Company description we are the company that cares - for our staff, for our clients, for our partners and for the quality of work we do. a dynamic, global company founded in 1995, we bring together more than 2,200 driven, dedicated and passionate individuals. we work on the frontline of medical science, changing lives, and bringing new medicines to those who need them. **job description**: you will contribute to statistical programming activities related to global clinical trials, work closely with international teams of statisticians, programmers and data managers, program data sets and summaries. **you will**: - develop analysis data sets structure - develop program requirements and specifications - be involved in sas programming of ads and tables, listings and figures - support sas program validations - prepare and review program documentation - produce tfl - communicate with project teams and company departments with regard to statistical programming of clinical research projects **qualifications**: - university and master's degree in applied science, mathematics, statistics or the like - knowledge of sas software (sas base/sas stat/sas graph) and experience of work in sas system - good knowledge of programming logic, sql and macro programming is preferred - proficient in english, spoken and written - experience within clinical trials and/or biostatistics - good analytical skills - excellent communication and interpersonal skills **please submit your cv in english** additional information our mission is to be the best cro in the world as me...
Company description psi is a leading contract research organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. we focus on delivering quality and on-time services across a variety of therapeutic indications. **job description**: psi **medical monitors **provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being. only cv's in english will be considered **responsibilities**: - advise clients, project teams, sites, data safety monitoring boards, regulatory agencies and third-party vendors on medical matters - collaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and different scientific presentations - review and analysis of clinical data to ensure the safety of study participants in clinical studies - ensure that the reported data is accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the currently approved protocol/amendments - address safety issues across the study from sites and the study team - review listings for coded events to verify medical dictionary for regulatory activities - participate in bid defense meetings - assist in pharmacovigilance activities - identify program risks, and create and implement mitigation strategies with clinical operations - ability to organize and lead clinical development advisory bo...
**company description** we are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. a dynamic, global company founded in 1995, we bring together more than 2,800 driven, dedicated and passionate individuals. we work on the frontline of medical science, changing lives, and bringing new medicines to those who need them. join our international team and be the key support to clinical research projects, streamlining communication, maintaining systems and managing documents & information. **only cvs in english will be accepted.** **you will be responsible for**: - being the main point of contact between site personnel and cra involved in the project helping on query resolution and edc completion - serves as the primary sites’ contact point for vendors, study supplies, and access management - ensure that pre-study testing (scans, mri/ct qualification questionnaires, test ecgs, etc.) of local site facilities is completed - act as the one who will ensure the order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies - ensures regulatory and ethics committee submissions and notifications, meaning you will need to be up to date on local regulations and dispositions - coordinate preparation for and follow-up on site, tmf and systems´ audits and inspections - manage the tmf on a site and a country level regularly and file documents. prepare, distribute, and update investigator site files (isf) and isf checklists - arrange and track initial and on-going project training ...
Company description we are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. a dynamic, global company founded in 1995, we bring together more than 2,000 driven, dedicated and passionate individuals. we work on the frontline of medical science, changing lives, and bringing new medicines to those who need them. **job description**: you will: - lead all biostatistics activities related to clinical trials as responsible project statistician - communicate with project teams, clients and vendors on statistical questions - develop and review statistical sections of protocols, including sample size calculations - develop statistical analysis plans - develop and document analysis database structures (i.e. sas analysis data set structures) - develop sas program requirements and specifications - sas programming and program validation - review and qc of statistical deliverables (tables, listings, figures, etc.) - perform statistical analysis and report results - consult on experimental design, statistical methods and approaches for the purpose of assessing safety and efficacy of drug products - liaise with dm on statistical questions related to data issues, including coordination of data transfers from dm to statistics - participate in bid defense meetings and kick-off meetings - train statisticians and sas programmers - prepare and deliver presentations at investigators' meetings - address audits findings/recommendations, and follow-up on and resolution of audit findings - participate in the developme...
Company description we are the company that cares - for our staff, for our clients, for our partners and for the quality of work we do. a dynamic, global company founded in 1995, we bring together more than 2,000 driven, dedicated and passionate individuals. we work on the frontline of medical science, changing lives, and bringing new medicines to those who need them. **job description**: you will contribute to statistical programming activities related to global clinical trials, work closely with international teams of statisticians, programmers and data managers, program data sets and summaries. home-based position **you will**: - develop analysis data sets structure - develop program requirements and specifications - be involved in sas programming of ads and tables, listings and figures - support sas program validations - prepare and review program documentation - produce tfl - communicate with project teams and company departments with regard to statistical programming of clinical research projects **qualifications**: - university degree in applied science, mathematics, statistics or similar - strong knowledge of and experience with sas software - good knowledge of programming logic, sql and macro programming is preferred - full proficiency in english, spoken and written - previous experience working with clinical trials - good analytical skills excellent communication and interpersonal skills **please submit your cv in english.** additional information make the right call and take your career to a whole new level. join the company that focu...
**company description** we are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. a dynamic, global company founded in 1995, we bring together more than 2,700 driven, dedicated and passionate individuals. we work on the frontline of medical science, changing lives, and bringing new medicines to those who need them. take your career to the next level and be involved in study startup processes in colombia. you will provide direct operational support to project teams and ensure that psi clinical projects start smoothly and on time. home-based you will: - oversee and coordinate the processes critical for clinical trial sites activation - communicate with project teams, investigative sites, review bodies, vendors, and clients regarding startup matters till the moment of site activation - support site identification and selection process - collect, review, and submit documents for ethics and regulatory review and approval - prepare packages of site documents for drug release to clinical sites - develop and negotiate site contracts and budgets - monitor startup metrics and timelines - coordinate initiatives for startup process improvement, analyze best practices and challenges **qualifications** - college/university degree or an equivalent combination of education, training and experience - minimum 3 years of industry experience in clinical research with practical startup experience in the country/ region - excellent knowledge of ich gcp, local laws and applicable regulations in the region - full w...
Company description we are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. a dynamic, global company founded in 1995, we bring together more than 2,500 driven, dedicated and passionate individuals. we work on the frontline of medical science, changing lives, and bringing new medicines to those who need them. if you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then psi is the right choice for you. **job description**: **only cvs in english will be considered.** **you will**: - facilitate regional projects as lead monitor and supervise study activities, timelines and schedules - train monitors in annotated monitoring visit reports - review monitoring reports and support monitors in their activities - act as the main communication line between monitor and regional lead - facilitate site budgets and contract negotiations - be a point of contact for in-house support services and vendors - communicate with internal project teams regarding study progress and lead project team calls on the country level - participate in quality control and compliance monitoring - may need to monitor and manage sites (if applicable) - may need to supervise monitors on site - oversee and maintain study-specific and corporate tracking systems at site and country level **qualifications**: - college/university degree in life sciences, pharmacy, rn or an equivalent combination of education, training & experience - participation in clinical project...
Company description we are the company that cares - for our staff, for our clients, for our partners and for the quality of work we do. a dynamic, global company founded in 1995, we bring together more than 2,200 driven, dedicated and passionate individuals. we work on the frontline of medical science, changing lives, and bringing new medicines to those who need them. job description you will contribute to statistical programming activities related to global clinical trials, work closely with international teams of statisticians, programmers and data managers, program data sets and summaries. **you will**: - develop analysis data sets structure - develop program requirements and specifications - be involved in sas programming of ads and tables, listings and figures - support sas program validations - prepare and review program documentation - produce tfl - communicate with project teams and company departments with regard to statistical programming of clinical research projects qualifications - university degree in applied science, mathematics, statistics or the like - experience in the clinical research industry (cro experience preferred) - knowledge of sas software (sas base/sas stat/sas graph) and experience of work in sas system - good knowledge of programming logic, sql and macro programming is preferred - experience within clinical trials and/or biostatistics - good analytical skills - excellent communication and interpersonal skills - intermediate english skills additional information make the right call and take your career to a whole n...
Company description we are the company that cares - for our staff, for our clients, for our partners and for the quality of work we do. a dynamic, global company founded in 1995, we bring together more than 2,000 driven, dedicated and passionate individuals. we work on the frontline of medical science, changing lives, and bringing new medicines to those who need them. **job description**: you will contribute to statistical programming activities related to global clinical trials, work closely with international teams of statisticians, programmers and data managers, program data sets and summaries. home-based position **you will**: - develop analysis data sets structure - develop program requirements and specifications - be involved in sas programming of ads and tables, listings and figures - support sas program validations - prepare and review program documentation - produce tfl - communicate with project teams and company departments with regard to statistical programming of clinical research projects **qualifications**: - university degree in applied science, mathematics, statistics or similar - strong knowledge of and experience with sas software - good knowledge of programming logic, sql and macro programming is preferred - full proficiency in english, spoken and written - previous experience working with clinical trials - good analytical skills excellent communication and interpersonal skills **please submit your cv in english.** additional information make the right call and take your career to a whole new level. join the company that focu...
Site management associate i psi cro ag bogota, d.c., capital district, colombia join our international team as a site management associate i, supporting clinical research projects by streamlining communication, maintaining systems, and managing documents and information. responsibilities include: acting as the main contact between site personnel and cras, assisting with queries and edc completion. serving as the primary contact for vendors, study supplies, and access management. ensuring pre-study testing of local site facilities is completed. assisting monitors with documentation in ctms and tracking site issues and actions. managing clinical supplies' order, receipt, storage, distribution, return, and reconciliation. handling regulatory submissions and notifications, staying updated on local regulations. coordinating audits and inspections. managing the tmf at site and country levels, including document filing and updates. organizing and tracking training for site teams on vendor systems. reviewing study documentation and translation statuses. ensuring proper safety information flow with investigative sites. qualifications: degree in life sciences. experience in administrative roles, preferably internationally. experience as a cta in cros and in clinical research. knowledge of local regulations. proficiency in english and spanish. skillful in ms office. ability to work dynamically in a team and communicate effectively. additional information: advance your career in clinical research by coordinating tasks and growing with the company. details: seniority level: entry level ...
Job description join our international team and be the key support to clinical research projects, streamlining communication, maintaining systems and managing documents & information. only cvs in english will be accepted. you will be responsible for: being the main point of contact between site personnel and cra involved in the project helping on query resolution and edc completion. serves as the primary sites’ contact point for vendors, study supplies, and access management. ensure that pre-study testing (scans, mri/ct qualification questionnaires, test ecgs, etc.) of local site facilities is completed assists the monitors in their prompt completion of all subject event and site event information in ctms. track the resolution status of site issues and action items in ctms. act as the one who will ensure the order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies. ensures regulatory and ethics committee submissions and notifications, meaning you will need to be up to date on local regulations and dispositions. coordinate preparation for and follow-up on site, tmf and systems´ audits and inspections. manage the tmf on a site and a country level for regularly and file documents. prepare, distribute, and update investigator site files (isf) and isf checklists. arrange and track initial and on-going project training for site teams in all vendor-related systems. document management and translations status review of the study. ensures proper safety information flow with investigative sites. qualifications college/university degr...
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