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. enablin...
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. enablin...
Description - external ppd’s mission is to improve health. it starts as an idea to find a cure. it becomes a life saved. all in-between, it’s you! we know that meaningful results not only require the right approach, but also the right people. we invite you to re-imagine health promoting protocols with us, working alongside our talented, bright, and energetic teams. from purchasing to global inventory management and from distribution to destruction, ppd’s integrated global clinical supplies (gcs) services are designed to increase speed and efficiency, without sacrificing the quality you expect. a procurement and logistics executive provides support to clinical supplies operations and administrative activities in all areas of clinical supplies lifecycle of low to moderate complexity studies. **activities** - actively participates in global project calls and lead discussions on assigned supply chains and liaises with global supply vendors. - makes global purchases, global distributions and deposit processes. - oversees post-sale services and process distribution. - must poses a solid understanding of the clinical supply process, such as manufacturing, handling, importing, shipping, exporting, auditing, labeling, and packaging - ensures all activities are executed in compliance with company good practices and client requirements. qualifications - external **requirements**: - bachelor degree - advanced english and good communication skills both written and verbal - proficient in microsoft office programs - strong customer service orientation and attention t...
Ppd’s mission is to improve health. it starts as an idea to find a cure. it becomes a life saved. all in-between, it’s you! we know that meaningful results not only require the right approach, but also the right people. we invite you to re-imagine health promoting protocols with us, working alongside our hardworking, bright and energetic teams. from purchasing to global inventory management and from distribution to destruction, ppd’s integrated global clinical supplies (gcs) services are designed to increase speed and efficiency, without sacrificing the quality you expect. as a project manager in clinical supplies, you will be r esponsible for providing overall global coordination of the entire clinical supplies lifecycle for the projects assigned. responsible for leading the more complex clinical supplies studies. at ppd we hire the best, develop ourselves and each other, and recognize the power of being one team. we offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees. summarized purpose: responsible for providing overall global coordination of the entire clinical supplies lifecycle for the projects assigned. responsible for running the more complex clinical supplies studies. these studies require primary and/or secondary packaging and labeling design, drug projections, drug distribution and returns, drug inventory management, budgeting and developing project specific material for multiple projects at the same time. provides consultation services to clients regarding global packaging, la...
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**: provides contracted project coordination and safety support on global and domestic programs with an emphasis on serious and non-serious adverse events, protocol inquiries, physician assessment of diagnostics, data and safety monitoring boards and endpoint adjudication committe...
A senior vendor management coordinator provides supply chain oversight for third party vendors. selects and contracts with appropriate vendors for scope of client's study. provides complete oversight of vendor supply chain for high complexity global clinical trials in multiple regions. provides financial control and oversight of pass-through budgets. ensures that vendors execute activities in accordance with contracted strategy. maintains close collaboration of i/e activities to ensure that appropriate regulations are followed for all countries imports and exports. acts as a representative for the vendor management department on all assigned projects. sets vendor strategy with external partners for procurement and depot vendors for particular clients. collaborates with vendors to improve processes and improve supply chain oversight, delivers trainings to vendor management team. mentors and provides guidance to junior members of the vendor management team....
**objetivo de la función** brindar soporte científico a clientes, vendedores y distribuidores. las principales responsabilidades incluyen: 1) actuar en preventa, cuando sea necesario, siendo un consultor tecnico ofreciendo a los clientes potenciales información técnica y demostraciones de productos que les ayuden en su decisión de compra; 2) brindar capacitación, asesoramiento tecnico y solución de problemas a los usuarios de productos thermo fisher scientific, ya sea en campo o de forma remota; 3) capacitar a los clientes internos; 4) participar en congresos y eventos científicos del área (incluso como disertante). **responsabilidades** brindar capacitación y soporte tecnico-científico a clientes internos y externos a traves de visitas técnicas, telefono o por correo electrónico, además de actividades secundarias como: visitas técnicas con el equipo comercial y participación en eventos de marketing. participar en eventos virtuales o presenciales realizados por la casa matriz para demostración de nuevas aplicaciones de productos y servicios. orientar al cliente en la elección del mejor producto y metodología, con el objetivo de satisfacer sus necesidades. ser capaz de asistir al cliente en la resolución de problemas de moderada complejidad relacionados con el uso de los productos de la empresa. demostrar equipos y reactivos en el centro de capacitación de la empresa o en los laboratorios de los clientes. asumir responsabilidades operativas y desarrollarse en las áreas de negocios corporativos a traves de la ejecución de sus proyectos internos y demandas interdepartame...
**work schedule** standard (mon-fri) **environmental conditions** office **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 mínimal 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...
Performs and coordinates all activities required to finalize site contracts (including, contractual terms and conditions, associated investigator grant budget(s) payment schedule terms and conditions, ancillary and site-specific documents), with investigator sites, pharmacies, laboratories or other relevant contractual parties during the lifecycle of the study. reviews ppd and/or client site contract, budget, payment schedule and ancillary documents templates for compliance with local legislation and practices. adapts the site contract template to client and investigational site requirements in collaboration with key stakeholders to include the project team and the ppd legal team. facilitates effective budget negotiation with site personnel in collaboration with key stakeholders. performs and coordinates all amendments to site contracts and financial agreements with investigator sites, pharmacies, laboratories or other relevant contractual parties during the lifecycle of the study. serves as contact with investigative sites for contractual issues and negotiations throughout the lifecycle of a study. assumes responsibility for any ongoing contract or budget amendments....
**responsibilities** - participates in kick-off meeting calls to create the best global strategy and recommend best proposals for procurement of supplies or depot services. - provides complete oversight of supply chain for global protocols, ensuring compliance in a dynamic environment throughout the lifecycle of the projects. - identify and mitigate potential risks that may impact project success and develop contingency plans to minimize the impact of risks. - monitors all activities are executed in compliance with sops, client requirement, and gxp. - primary point of escalation for intricate situations, consistently delivering swift resolutions. - participate in calls with suppliers and vendor oversight managers to explore and expedite solutions. - develops, implements, and provides training for tools centered around process improvement. - lead calls with vendor management team to provide guidance on vendor management process, tools, vendor issues, etc - oversees project financial control at client level with a focus on purchase orders (po) budget ensuring compliance with financial objectives. - identify areas for improvement and suggest new methods and approaches. **job qualification**: - bachelor's degree in business, supply chain management, finance, economics, or related field - at least years 3 of experience in a procurement/sourcing role - excellent communication skills both verbal and written - ability to develop and maintain supplier relationships - proficient in microsoft office suite - knowledge of erp systems and other procurement systems...
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. **location/division specific information**: our project delivery colleagues within ppd® clinical research services direct, coordinate and manage the technical and operational aspects of projects, securing the successful completion of clinical trials. through our diverse team, our members engage in variety of initiatives and projects, or are part of global project teams gaining cross-cultural experience. therapeutic scope include hematology/oncology. **discover impactful work**: the clinical team manager (ctm) combines deep knowledge, therapeutic expertise, and robust tools to help our clients deliver life-changing therapies to market. the ctm takes ownership of clinical deliverables, anticipates problems, finds solutions and delivers results. **a day in the life of a ctm**: ...
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 currently seeking a senior regulatory affairs specialist to join our growing regulatory affairs department - regulatory liaison team. this is a fantastic opportunity to further your regulatory career and develop your expertise in this field. **senior regulatory affairs specialist - reg liaison** in this role you will be a pivotal team member with ideally with regulatory experience. you will provide innovative solutions including global regulatory therapeutic area expertise and client interface to provide strategic regulatory intelligence, guidance and regulatory expertise for product development from preclinical through registration and product optimization. you will feel confident providing regulatory advice and carry out projects in the provision of regulatory affairs ser...
**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 crecim...
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. **location/division specific information**: our project delivery colleagues within ppd® clinical research services direct, coordinate and manage the technical and operational aspects of projects, securing the successful completion of clinical trials. through our diverse team, our members engage in variety of initiatives and projects, or are part of global project teams gaining cross-cultural experience. therapeutic scope includes: hematology/oncology, vaccines, infectious and respiratory diseases, general medicine, neurosciences and cardiovascular/metabolic. **discover impactful work**: the clinical team manager (ctm) combines deep knowledge, therapeutic expertise, and robust tools to help our clients deliver life-changing therapies to market. the ctm takes ownership of clinical...
**(senior) project manager/lead (delivery)** 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 project delivery colleagues within our ppd® clinical research services direct, coordinate and manage the technical and operational aspects of projects, securing the successful completion of clinical trials. this includes collaborating with functional area leads to identify and evaluate fundamental issues on the project and to ensure that solutions are implemented. project delivery is vital to helping our customers deliver life-changing therapies. through our global team, you may engage in diverse initiatives and projects, or be part of a virtual international project team gaining cross-cultural experience. **the therapeutic scope includes general medicine-** **the therapeutic scope includes general medicine-** dermatology, gi, (uc...
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 project delivery colleagues within our ppd® clinical research services direct, coordinate and manage the technical and operational aspects of projects, securing the successful completion of clinical trials. this includes collaborating with functional area leads to identify and evaluate fundamental issues on the project and to ensure that solutions are implemented. project delivery is vital to helping our customers deliver life-changing therapies. through our global team, you may engage in diverse initiatives and projects, or be part of a virtual international project team gaining cross-cultural experience. therapeutic scopes include oncology/hematology. **discover impactful work**: we are seeking a **project manager/lead** in our **delivery team (therapy area**). this role wi...
We are vital links between an idea for a new medicine and the people who need it. we are the people of ppd — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. you will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients. our **global clinical supplies** team cover all aspects from purchasing to global inventory management and from distribution to destruction. we have a new vacancy for **project manager/senior project manager** (depending on experience) for our **global clinical supplies team** to be based in the **latam** **region**. this can be office based or home based. **key responsibilities**: a project manager (pm) in the gcs team is responsible for providing overall global coordination of the entire clinical supplies lifecycle for the projects assigned. also responsible for managing the more complex clinical supplies studies. these studies require primary and/or secondary packaging and labelling design, drug projections, drug distribution and returns, drug inventory management, budgeting and developing project specific material for multiple projects at the same time. the pm provides consultation services to clients regarding global packaging, labelling, and distribution requirements. this person also serves as the main point of contact between the client, clinical project teams, third party vendors, and study sites. **education and experience**: - bachelor's degree in a science or related disci...
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...
• 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....
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...
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 ...
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 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...
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...
(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...
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...
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...
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. enablin...
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