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VENDOR MANAGEMENT COORDINATOR

Work schedule standard (mon-fri) environmental conditions office job description are you an ambitious and proven professional looking for an exceptional opportunity to showcase your strong work ethic and skills? thermo fisher scientific inc. is seeki...


SENIOR ICF MEDICAL WRITING PROJECT MANAGER

Work schedule standard (mon-fri) environmental conditions office job description thermo fisher scientific offers impactful work globally, enabling customers to improve health and safety. we have a vacancy for a senior icf medical writing project mana...


PV COORDINATOR

Work schedule standard (mon-fri) environmental conditions office job description at thermo fisher scientific, you’ll discover meaningful work that makes a positive impact on a global scale. join our colleagues in bringing our mission to life - enabling our customers to make the world healthier, cleaner and safer. we provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. with clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our ppd clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. discover impactful work: provides administrative safety support to the pharmacovigilance department. specifically in relation to submissions, tracking and subsequent filing and archiving or expedited and periodic safety reports. this includes other general administration tasks such as filing, photocopying, typing and performing reconciliation tasks. involved in projects relating to safety reporting. may mentor or train new central safety reporting admin staff. a day in the life: • responsible for the submission of safety reports to applicable parties, including subsequent scanning, indexing and filing (both electronic and paper), safety tracker completion and quality check, and archiving in accordance with ...


SR SAFETY REPORTING SPECIALIST - YQS336

Work schedule standard (mon-fri) environmental conditions office job description at thermo fisher scientific, you’ll discover meaningful work that makes a positive impact on a global scale. join our colleagues in bringing our mission to life - enabling our customers to make the world healthier, cleaner and safer. we provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. with clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our ppd clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. essential functions 1. receives, prepares and submits safety reports to applicable parties. 2. ensures that all reports are compliant with regulatory timelines and country legislation and monitors this on a regular basis. 3. leads large scale projects effectively, ensuring safety reports are submitted in accordance with the agreed processes and regulatory timelines. 4. provides input and feedback to aid the development of program and departmental procedural documents. 5. shares ideas and suggestions with team members. 6. takes an active role in the development and implementation of ideas and suggestions. 7. liaises with relevant departments around safety reporting tasks and attends vario...


SAFETY REPORTING COORD | TRB920

Work schedule standard (mon-fri) environmental conditions office job description at thermo fisher scientific, you’ll discover meaningful work that makes a positive impact on a global scale. join our colleagues in bringing our mission to life - enabling our customers to make the world healthier, cleaner and safer. we provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. with clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our ppd clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. discover impactful work: provides administrative safety support to the pharmacovigilance (pv) department. this includes other general administration tasks such as filing, photocopying, typing and performing reconciliation tasks. involved in projects relating to pv safety. may mentor or train new pv safety administration staff. a day in the life: •provides assistance and liaises with relevant teams and departments on a various range of administrative pv safety tasks, including audit readiness activities, meeting organisation, minute taking, filing, photocopying, work distribution, reconciling reports, end of day emails completing metrics and updating ppd systems with project allocation. •resp...


[DOJ982] | SR SAFETY REPORTING SPEC

Work schedule standard (mon-fri) environmental conditions office job description essential functions and other job information receives, prepares and submits safety reports to applicable parties. ensures that all reports are compliant with regulatory timelines and country legislation and monitors this on a regular basis. leads large scale projects effectively, ensuring safety reports are submitted in accordance with the agreed processes and regulatory timelines. provides input and feedback to aid the development of program and departmental procedural documents. shares ideas and suggestions with team members. takes an active role in the development and implementation of ideas and suggestions. liaises with relevant departments around safety reporting tasks and attends various meetings as required. provides input, feedback and guidance to other team members and mentors newstarters. produces metrics and has some involvement in financial project. qualifications: education and experience: bachelor's degree or equivalent and relevant formal academic / vocational qualification. previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to5+ years’). working conditions and environment: work is performed in an office/ laboratory and/or a clinical environment. exposure to biological fluids with potential exposure to infectious organisms. exposure to electrical office equipment. personal protective equipment required such as protective eyewear, garments and glove #j-18808-ljbffr...


[JBG583] - SAFETY REPORTING SPECIALIST

Work schedule standard (mon-fri) environmental conditions office job description at thermo fisher scientific, you’ll discover meaningful work that makes a positive impact on a global scale. join our colleagues in bringing our mission to life - enabling our customers to make the world healthier, cleaner and safer. we provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. with clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our ppd clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.our detailed, goal-oriented pharmacovigilance colleagues manage the safety profile of new drugs in clinical trials, oversee case-processing activities through all phases of development and perform regulatory reporting and medical monitoring.as part of your work with beginning-to-end trial experience, you will expand your knowledge and experience working on clinical trials through every stage of drug development. this includes management and oversight of all contracted services.discover impactful work:as a safety reporting specialist, you will be responsible for receipt, submission, and subsequent tracking of expedited and periodic safety reports pertaining to the department’s projects. you will assi...


PV COORDINATOR (HKR916)

Work schedule standard (mon-fri) environmental conditions office job description at thermo fisher scientific, you’ll discover meaningful work that makes a positive impact on a global scale. join our colleagues in bringing our mission to life - enabling our customers to make the world healthier, cleaner and safer. we provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. with clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our ppd clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.discover impactful work:provides administrative safety support to the pharmacovigilance (pv) department. this includes other general administration tasks such as filing, photocopying, typing and performing reconciliation tasks. involved in projects relating to pv safety. may mentor or train new pv safety administration staff.a day in the life:• provides assistance and liaises with relevant teams and departments on a various range of administrative pv safety tasks, including audit readiness activities, meeting organisation, minute taking, filing, photocopying, work distribution, reconciling reports, end of day emails completing metrics and updating ppd systems with project allocation.• responsible fo...


WEY206 - FIELD APPLICATIONS SCIENTIST NGS COLOMBIA & CENTRAL

Work schedule standard (mon-fri) environmental conditions office el especialista de aplicaciones en campo promueve el soporte científico en las áreas de biología celular y molecular a clientes, vendedores y representantes. además, brinda entrenamiento sobre los productos e instrumentos de thermo fisher scientific orientado en la satisfacción del cliente. principales responsabilidades: brindar soporte y entrenamiento, asistencia técnica, estandarización de protocolos, participación de eventos de marketing, apoyo en demostraciones de producto y resolución de problemas a los usuarios de los productos de thermo fisher. proporcionar informaciones sobre el mercado a través de oportunidades para apoyar el desarrollo de las estrategias de venta, además de actuar en actividades secundarias internas y externas administrando entrenamientos, participando de congresos (como orador, inclusive) y atendiendo en campo para aclarar dudas sobre aplicaciones y para resolver problemas con el uso de productos thermo fisher scientific. apoyo en la orientación al cliente en la elección del mejor producto y metodología, buscando el atendimiento de sus necesidades y la promoción de los productos del portafolio de thermofisher; participar de eventos comerciales y científicos donde thermofisher sea patrocinadora, aclarando dudas, analizando posibilidades de aplicación de soluciones y divulgando los productos y servicios del portafolio de la compañía. asumir responsabilidades operativas y desarrollarse en áreas de negocios corporativos a fin de viabilizar el crecimiento sustentable del d...


SAFETY REPORTING SPECIALIST

Work schedule standard (mon-fri) environmental conditions office job description at thermo fisher scientific, you’ll discover meaningful work that makes a positive impact on a global scale. join our colleagues in bringing our mission to life - enabling our customers to make the world healthier, cleaner and safer. we provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. with clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our ppd clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.our detailed, goal-oriented pharmacovigilance colleagues manage the safety profile of new drugs in clinical trials, oversee case-processing activities through all phases of development and perform regulatory reporting and medical monitoring.as part of your work with beginning-to-end trial experience, you will expand your knowledge and experience working on clinical trials through every stage of drug development. this includes management and oversight of all contracted services.discover impactful work:as a safety reporting specialist, you will be responsible for receipt, submission, and subsequent tracking of expedited and periodic safety reports pertaining to the department’s projects. you will assist manage...


PV COORDINATOR

Work schedule standard (mon-fri) environmental conditions office job description at thermo fisher scientific, you’ll discover meaningful work that makes a positive impact on a global scale. join our colleagues in bringing our mission to life - enabling our customers to make the world healthier, cleaner and safer. we provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. with clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our ppd clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.discover impactful work:provides administrative safety support to the pharmacovigilance (pv) department. this includes other general administration tasks such as filing, photocopying, typing and performing reconciliation tasks. involved in projects relating to pv safety. may mentor or train new pv safety administration staff.a day in the life:• provides assistance and liaises with relevant teams and departments on a various range of administrative pv safety tasks, including audit readiness activities, meeting organisation, minute taking, filing, photocopying, work distribution, reconciling reports, end of day emails completing metrics and updating ppd systems with project allocation.• responsible for extract...


SR SAFETY REPORTING SPECIALIST

Work schedule standard (mon-fri) environmental conditions office job description at thermo fisher scientific, you’ll discover meaningful work that makes a positive impact on a global scale. join our colleagues in bringing our mission to life - enabling our customers to make the world healthier, cleaner and safer. we provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. with clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our ppd clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. essential functions receives, prepares and submits safety reports to applicable parties. ensures that all reports are compliant with regulatory timelines and country legislation and monitors this on a regular basis. leads large scale projects effectively, ensuring safety reports are submitted in accordance with the agreed processes and regulatory timelines. provides input and feedback to aid the development of program and departmental procedural documents. shares ideas and suggestions with team members. takes an active role in the development and implementation of ideas and suggestions. liaises with relevant departments around safety reporting tasks and attends various meetings a...


(OC144) | SR SAFETY REPORTING SPECIALIST

**work schedule** standard (mon-fri) **environmental conditions** office at thermo fisher scientific, you’ll discover meaningful work that makes a positive impact on a global scale. join our colleagues in bringing our mission to life - enabling our customers to make the world healthier, cleaner and safer. we provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. with clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our ppd clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. essential functions receives, prepares and submits safety reports to applicable parties. ensures that all reports are compliant with regulatory timelines and country legislation and monitors this on a regular basis.leads large scale projects effectively, ensuring safety reports are submitted in accordance with the agreed processes and regulatory timelines.provides input and feedback to aid the development of program and departmental procedural documents.shares ideas and suggestions with team members. takes an active role in the development and implementation of ideas and suggestions.liaises with relevant departments around safety reporting tasks and attends various meetings as required.provides input, feedb...


LOGISTICS SPECIALIST I - [COM771]

**actividades**: coordinar y dar cumplimiento a las actividades relacionadas con los proyectos a nível local. esto implica realizar, verificar, asesorar, documentar, generar reportes y mantener el flujo de comunicación dentro del equipo del proyecto para los procesos de recepción, almacenamiento, preparación y embalado de envíos, despacho, devolución, etiquetado/re-etiquetado, reconciliación y destrucción de medicamentos y de suministros clínicos. revisar e implementar los procesos de operaciones logísticas y de control de gestión operativa del establecimiento tercerista contratado por fisher clinical services. estas actividades se realizarán siguiendo las buenas prácticas de fabricación, almacenamiento y distribución, minimizando la cantidad de desvíos en calidad. todas estas operaciones logísticas deberán ser llevadas a cabo de acuerdo a las especificaciones, procedimientos, instrucciones y herramientas informáticas/administrativas requeridas por la compañía y/o cliente. **requisitos básicos mínimos**: - conocimientos de normas gmp, bioseguridad, regulaciones locales y sops. - paquete microsoft office. **evaluación de excel intermedio.**: - experiência en actividad logística y almacenamiento en productos farmacéuticos. **educación/experiência**: - graduados en áreas de la salud, ingeniería, operaciones logísticas, administración. - experiência de hasta **2/3 años en tareas similares en industria farmacéutica, cros, o compañías similares de logística.** idiomas**:inglés oral y escrito nível intermedio-se evaluará escritura.** **habilidades y/o competencia...


C584 - PV COORDINATOR

**work schedule** standard (mon-fri) **environmental conditions** office...


VENDOR MANAGEMENT COORDINATOR (XAA-793)

Work schedule standard (mon-fri) environmental conditions office job description are you an ambitious and proven professional looking for an exceptional opportunity to showcase your strong work ethic and skills? thermo fisher scientific inc. is seeking an individual with a track record of success in vendor management to join our world-class team of researchers. as a leader in the scientific industry, we are dedicated to enabling our customers to make the world healthier, cleaner, and safer. responsibilities: - collaborate with cross-functional teams to determine vendor requirements and establish sourcing strategies. - manage vendor relationships and contracts, ensuring flawless execution and delivery. - conduct market research and competitive analysis to identify potential vendors. - develop and implement vendor performance metrics and conduct regular evaluations. - drive continuous improvement initiatives to optimize vendor management processes. requirements: - bachelor's degree in business administration or related field, or equivalent experience in the industry. - previous experience in vendor management or procurement. - strong analytical and negotiation skills. - excellent communication and interpersonal skills. - proven ability to successfully implement vendor management strategies. at thermo fisher scientific, we value diversity and inclusivity. we believe that collaboration and different perspectives drive innovation and lead to exceptional results. we are an equal opportunity employer and strictly prohibit discrimination based on race, c...


CLINICAL SUPPLIES OVERSIGHT MANAGER

Full time Tiempo completo

At thermo fisher scientific, you’ll discover meaningful work that makes a positive impact on a global scale. join our colleagues in bringing our mission to life - enabling our customers to make the world healthier, cleaner and safer. we provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. with clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our ppd clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. we are seeking a in our global clinical supplies team (based serbia or bulgaria ). the role can be fully homebased (or office, hybrid in sofia or belgrade) this role manages the full supply chain oversight for high complex global clinical trials. ensures project/study activities are in compliance with company and client requirements. mentors, trains and provides on-going support to junior team members. may act as main contact and escalation point for assigned clients. provides consultation services to clients and may develop and update client-specific manuals. builds and maintains client relationships. a day in the life develops study specific plans for each assigned project. meets with internal teams to coordinate efforts, provide recommendations and risks, and update project reports/s...


ASSOC IMPORT/EXPORT COORD

Full time Tiempo completo

• coordinates, supports and performs administrative work to support the department. • supports the day to day operations of the study drug, comparators and ancillaries management. • supports department project teams as assigned member. • completes role specific training compliance and timesheets completion and release. • may coordinate or serve as a liason cross-functionally. • executes import & export activities according to ppd requirements, client requirements and applicable regulations. • executes the import & export / trade compliance plan for each project assigned. • meet with the trade compliance manager to discuss import & export issues. provides appropriate recommendations and alerts. • participates in ongoing training on new regulations concerning import/exports activities. • maintain updated ppd owned metrics indicators reports. • works under supervision and on low complexity trials....


PROJECT & BUDGET ANALYST

Full time Tiempo completo

Summarized purpose: contributes to the achievement of financial and business objectives through timely monitoring and analysis of budgets and resource data for assigned project portfolio. works cross-functionally with other departments and functional project leads to complete assigned tasks on time. essential functions and other job information: essential functions administers the daily financial management of simple or moderately complex studies, for the functional area's portion of a project budget, as assigned with minimal supervision. performs review of contract and bidding assumptions. performs analysis of budget to actual data on monthly or other specified basis. works closely with project lead to update resource forecasts and unit grids, present and resolve pending issues with resource forecasts, unit grids and contract modifications. works closely with other departments and project lead to oversee financial aspects of functional area's portion of projects. assists project team to identify risks, define reasons for unsupported hours, and attends risk meetings as needed. prepares estimates for contract modifications. job complexity works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. job knowledge developing professional expertise, applies company policies and procedures to resolve a variety of issues. supervision received normally receives general instructions on routine work, detailed instructions on new projects or assignments. exercises judgment within defined procedures and practices to determine appr...


CLINICAL TRIAL COORDINATOR FSP LATAM

Full time Tiempo completo

Summarized purpose: provides administrative and technical support to the project team. supports audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's sop and department guidance document. provides administrative support for site activation activities. aids the development of the critical path for site activation within assigned projects in support of rapid site activations. represents crg personnel. may utilize local knowledge, organization systems, external site lists and sponsor directives to develop and review site lists that are suitable for the strategic needs of feasibility activities and to provide local input into the site tiering process. may act as a buddy during onboarding phase and provide training to new staff as needed. essential functions: according to the specific role (central or local), coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix. performs department, internal, country and investigator file reviews as assigned, and documents findings in appropriate system(s). ensures allocated tasks are performed on time, within budget and to a highquality standard. proactively communicates any risks to project leads. provides system support (, activate & etmf) and ensures system databases are always current. performs administrative tasks on assigned trials, including, but not limited to, timely processing of documents sent to client (e)tmf as assigned, performing (e)tmf reviews, distributing mass mailings and communications as needed, providing documents and ...


START-UP TEAM SPECIALIST (CLINICAL TRIAL)

Full time Tiempo completo

Summarized purpose: completes site activation or amendment deliverables within the assigned projects and ensures all project deliverables meet customer expectations, as well as, contracted deliverables by providing accurate projections, report updates, and ongoing risk assessments. essential functions: • collaborates with multiple team members in a matrix environment for the effective delivery of site activation or amendments within assigned projects. • assists with coordination of the flow of information between internal teams, clients, or functional departments involved in site activation or amendments. • participates in developing plans/guidelines for project implementation. • monitors and analyzes project status to ensure successful progress and completion of all assigned projects and provides metrics and status updates to senior team members and/or upper management. • performs risk identification and contingency planning. • collaborates with team members to manage financial and contractual aspects of the studies related to site activation or amendments. • participates in establishing appropriate controls to ensure that project resources and expenses are aligned with budgets. education and experience: bachelor's degree or equivalent and relevant formal academic / vocational qualification previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years’). in some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be conside...


MANAGER/SENIOR MANAGER REGULATORY AFFAIRS

Manager/senior manager regulatory affairs join to apply for the manager/senior manager regulatory affairs role at thermo fisher scientific manager/senior manager regulatory affairs 1 day ago be among the first 25 applicants join to apply for the manager/senior manager regulatory affairs role at thermo fisher scientific works with global regulatory lead(s), regulatory strategists, global regulatory sub-teams and project teams regarding the development and execution of regulatory strategy through the product development lifecycle. coordinate, develop and contribute to content and format of regulatory submissions and related supplements and amendments, including fda meeting requests, briefing books, inds, ctas, pediatric plans, dsurs, maa/bla/nda, etc. identify and assess regulatory risks for assigned projects or programs. senior manager may serve as point of contact with regulatory agencies relevant to assigned projects or programs, as appropriate. ability to work both independently and within project teams, committees, etc. to achieve group goals. accountable for tracking, following up and archiving correspondence, regulatory commitments, and queries from health agencies
work schedule
standard (mon-fri) environmental conditions
office here’s what you’ll do:
works with global regulatory lead(s), regulatory strategists, global regulatory sub-teams and project teams regarding the development and execution of regulatory strategy through the product development lifecycle. coordinate, develop and contribute to content and format of regulatory submis...


RESEARCH ASSOCIATE II

Full time Tiempo completo

Location/division specific information our multidisciplinary modelling and simulation experts design and implement health economic models that describe complex medical processes to understand and evaluate the implications of clinical trials; demonstrate the value of interventions beyond efficacy, and assess benefits, risks, and the economic consequences associated with healthcare interventions. this role offers 100% remote working flexibility. discover impactful work: if you have a passion for health economic modeling to conduct cost-effectiveness analyses of healthcare interventions and have experience conceptualizing and implementing simulation models (, discrete event simulation) and other decision-analytic models (, decision trees, markov, individual state-transition, survival partition), a position in modelling and simulation at evidera is waiting for you! a day in the life: implement simulation models (, discrete event simulation) and other decision-analytic models (, decision trees, markov, individual state-transition, survival partition) to assess the cost-effectiveness of healthcare interventions. support scientific and financial project management, scoping, tracking progress, and teamwork for multiple projects. implement one or more of the following under direction: design and development of health economic models to conduct cost-effectiveness and budget impact analyses of healthcare interventions. program models using microsoft excel with visual basic for applications (vba) or simulation specialised software. conduct literature reviews with emphasis on extracting...


RESEARCH ASSOCIATE I

Full time Tiempo completo

(other duties may be assigned): • assist with implementing one or more of the following (under supervision): • development of health economic models to conduct cost-effectiveness and budget impact analyses of healthcare interventions. • program models using microsoft excel with visual basic for applications (vba). • conduct analyses and presentation of results. • conduct literature reviews with emphasis on extracting data pertinent to health economic evaluations and cost-effectiveness analyses. • conduct basic statistical analyses (, descriptive statistics and regression analysis). • assist with drafting sections of project deliverables (, user guides, model specifications and technical reports). • participate in client meetings and draft meeting minutes. • assist with tracking budget and expenses and monitoring timelines and deliverables for projects when assigned. • support other "non-billable" activities as needed (, assist with developing sections of proposals). • travel may be required. education, professional skills & experience: • master’s degree in operations research or industrial engineering or bachelor’s degree in operations research or industrial engineering with more than one year of relevant work experience. • master’s or bachelor’s degrees in other fields will be considered (, mathematics, economics, epidemiology) with relevant experience of programming decision analytic models (, decision trees, markov, individual state-transition, survival partition) in microsoft excel with vba. computer skills • required: excel and vba ex...


SR CRA (LEVEL I)

Full time Tiempo completo

Summarized purpose: performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ich gcp, fda guidelines, local regulations and ppd sops. conducts site visits to assess protocol and regulatory compliance and manages required documentation. ensures that data will pass international quality assurance audits. represents ppd in the global medical research community and develops and maintains collaborative relationships with investigational sites and client company personnel. may assist project manager or clinical team manager on assigned projects. generally required to travel 60-80% but more for some individuals. essential functions and other job information: monitors investigator sites to ensure the accuracy and validity of crf entries in functions relation to patient records/clinic notes (source document verification). assess investigational product through physical inventory and records review. documents observations in reports and letters in a timely manner using approved business writing standards. escalates observed deficiencies and issues to clinical management expeditiously, proposes solutions and follow all issues through to resolution. maintains regular contact between monitoring visits with investigative sites to prove that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. conducts monitoring tasks in accordance with the approved monitoring plan. provides trial status tracking and progress update reports to the clinical team man...


FSP CLINICAL TRIAL COORDINATOR II

Full time Tiempo completo

At thermo fisher scientific, you’ll discover meaningful work that makes a positive impact on a global scale. join our colleagues in bringing our mission to life - enabling our customers to make the world healthier, cleaner and safer. we provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. with clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our ppd clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. our global clinical operations colleagues within our ppd clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies. discover impactful work: provides administrative and technical support to the project team. supports audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's sop and department guidance document. provides administrative support for site activation activities. aids the development of the critical path for site activation within assigned projects in support of rapid site a...


SAFETY REPORTING COORDINATOR

Full time Tiempo completo

At thermo fisher scientific, you’ll discover meaningful work that makes a positive impact on a global scale. join our colleagues in bringing our mission to life - enabling our customers to make the world healthier, cleaner and safer. we provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. with clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our ppd clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. discover impactful work: provides administrative safety support to the safety reporting team and pharmacovigilance department. responsible for tasks related to receipt and submission of expedited and periodic safety reports, including quality check tasks, pertaining to the department’s projects. assists management in producing project metrics as required. involved in projects and programs relating to safety reporting and may take a lead role on projects. alerts manager to any quality or timeline issues and takes a proactive approach in the identification and resolution of such issues. may also be involved in updates to procedures and other initiatives related to safety reporting. may mentor or train new central safety reporting staff. hybrid working type a day in the life: • recei...


SR KEY ACCOUNTS MANAGER HID

Work schedule standard (mon-fri) environmental conditions office job description the senior key account manager (kam) for human identification (hid) at thermo fisher scientific has a range of responsibilities, including: customer relations: developin...


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