Clinical Trial Programming Specialist
6 days ago
We are seeking a highly skilled and experienced Statistical Programmer Lead to join our team at Everest Clinical Research Services Inc. As a key member of our programming team, you will be responsible for leading complex statistical programming projects and ensuring the delivery of high-quality results.
Key Responsibilities- Lead projects with higher levels of complexity, challenge, and difficulty, and lead efforts to resolve complex statistical programming issues or problems.
- Apply project management skills and statistical programming techniques to lead assigned projects, achieving on-time delivery of deliverables with quality, and earning client trust and repeat business.
- Represent the company in interactions with clients regarding statistical programming projects and relevant businesses, such as programming oversight, project cost estimates, and proposal development.
- Under supervision, represent the company to interact with regulatory agencies regarding matters relating to responsible projects/programs.
- Provide training, mentorship, and technical guidance to less experienced Statistical Programmers or Biostatisticians who perform statistical programming.
- Develop SDTM and ADaM dataset specifications for CSRs, ISS, and ISE following company or client Standard Operating Procedures (SOPs) and project-specific requirements.
- Program and validate SDTM and ADaM datasets following approved dataset specifications for CSRs, ISS, and ISE.
- Perform CDISC standard compliant checks on SDTM and ADaM datasets, generate, review, and resolve Pinnacle 21 validation issues, and perform additional QC checks using company Working Instruction (WI) checklists.
- Perform overall quality/consistency review of statistical TLGs before delivering them to the internal team or the client.
- Create SDTM and ADaM define.xml files, and table of contents, and perform QC review of these files prepared by others.
- Participate and/or lead programming teams in support of product regulatory submission related activities.
- Perform quality review/assessment on regulatory submission programming documents, datasets, computer programs, etc.
- Learn and maintain expertise in the use of the utilities and macros developed for the Statistical Programmers, and develop new macros and utilities.
- Program and perform QC/validation of complex data integrity checks to ensure data quality and ongoing scientific data surveillance.
- Complete job-required and project-specific training, comply with applicable company and trial Sponsor's Policies, SOPs, and WIs, document data and programming information in accordance with corporate SOPs and guidelines, and archive clinical trial data (SDTM and ADaM datasets) and programming information in accordance with corporate archival SOPs and guidelines.
- May lead programming efforts for assigned client clusters when required.
A Master's or Ph.D. degree in Statistics, Biostatistics, Epidemiology, and Computer Sciences, with at least 8 years of experience in clinical trial statistical programming, or a Bachelor's degree in the above fields with at least 10 years of experience in clinical trial statistical programming.
-
Clinical Trials Specialist
6 days ago
Toronto, Ontario, Canada Ozmosis Research Inc. Full timeAbout Ozmosis Research Inc.Ozmosis Research Inc. is a leading independent clinical trials management company in Canada, operating as a social enterprise. We are a trusted partner for biotechnology and pharmaceutical companies, as well as academic institutions and investigators.Job SummaryWe are seeking a highly skilled Clinical Trials Specialist to join our...
-
Clinical Trials Specialist
6 days ago
Toronto, Ontario, Canada Ozmosis Research Inc. Full timeAbout Ozmosis Research Inc.Ozmosis Research Inc. is a leading independent clinical trials management company in Canada, operating as a social enterprise. We are a trusted partner for biotechnology and pharmaceutical companies, as well as academic institutions and investigators.Job SummaryWe are seeking a highly skilled Clinical Trials Specialist to join our...
-
Clinical Trials Coordinator
6 days ago
Toronto, Ontario, Canada Ozmosis Research Inc. Full timeAbout the RoleOzmosis Research Inc. is a leading clinical trials management company that promotes a strong team environment and is seeking a highly skilled and experienced professional to join our team.We are seeking a Clinical Trials Specialist to participate in project management of clinical trials from protocol development and review through to...
-
Clinical Trials Coordinator
6 days ago
Toronto, Ontario, Canada Ozmosis Research Inc. Full timeAbout the RoleOzmosis Research Inc. is a leading clinical trials management company that promotes a strong team environment and is seeking a highly skilled and experienced professional to join our team.We are seeking a Clinical Trials Specialist to participate in project management of clinical trials from protocol development and review through to...
-
Clinical Trials Coordinator
3 days ago
Toronto, Ontario, Canada Ozmosis Research Inc. Full timeAbout Ozmosis Research Inc.We are a dynamic and innovative research organization dedicated to advancing critical care research.Job SummaryWe are seeking a highly motivated and experienced Clinical Trials Specialist to join our team. The successful candidate will have a strong background in critical care clinical trials management and project management.Key...
-
Clinical Trials Coordinator
3 days ago
Toronto, Ontario, Canada Ozmosis Research Inc. Full timeAbout Ozmosis Research Inc.We are a dynamic and innovative research organization dedicated to advancing critical care research.Job SummaryWe are seeking a highly motivated and experienced Clinical Trials Specialist to join our team. The successful candidate will have a strong background in critical care clinical trials management and project management.Key...
-
Clinical Trials IWRS Monitor I
7 days ago
Toronto, Ontario, Canada Everest Clinical Research Services Inc Full timeEverest Clinical Research Services Inc is a leading contract research organization (CRO) providing a broad range of expertise-based clinical research services to the pharmaceutical, biotechnology, and medical device industries. We serve some of the most renowned companies and work with many of the most advanced drugs, biologics, and medical devices in...
-
Clinical Trials IWRS Monitor I
6 days ago
Toronto, Ontario, Canada Everest Clinical Research Services Inc Full timeEverest Clinical Research Services Inc is a leading contract research organization (CRO) providing a broad range of expertise-based clinical research services to the pharmaceutical, biotechnology, and medical device industries. We serve some of the most renowned companies and work with many of the most advanced drugs, biologics, and medical devices in...
-
Lead Clinical Trial IWRS Specialist
4 weeks ago
Toronto, Ontario, Canada Everest Clinical Research Services Inc Full timeCompany Overview:Everest Clinical Research Services Inc. is a reputable contract research organization dedicated to providing a comprehensive array of clinical research solutions to the pharmaceutical, biotechnology, and medical device sectors globally. With an unwavering commitment to quality outcomes, exceptional client service, and adaptability, Everest...
-
Senior Project Manager
7 days ago
Old Toronto, Ontario, Canada Worldwide Clinical Trials Full timeJob Summary:We are seeking a highly skilled Senior Project Manager to join our team at Worldwide Clinical Trials. As a Senior Project Manager, you will be responsible for leading cross-functional teams and overseeing the execution of clinical trials from start to finish.About Us:Worldwide Clinical Trials is a leading global contract research organization...
-
Senior Project Manager
6 days ago
Old Toronto, Ontario, Canada Worldwide Clinical Trials Full timeJob SummaryWe are seeking a highly skilled Senior Project Manager to join our team at Worldwide Clinical Trials. As a key member of our organization, you will be responsible for leading complex clinical trials projects from start to finish.About UsWorldwide Clinical Trials is a leading global contract research organization (CRO) that partners with...
-
Senior Project Manager
6 days ago
Old Toronto, Ontario, Canada Worldwide Clinical Trials Full timeJob SummaryWe are seeking a highly skilled Senior Project Manager to join our team at Worldwide Clinical Trials. As a key member of our organization, you will be responsible for leading complex clinical trials projects from start to finish.About UsWorldwide Clinical Trials is a leading global contract research organization (CRO) that partners with...
-
Senior Project Manager
6 days ago
Old Toronto, Ontario, Canada Worldwide Clinical Trials Full timeJob Summary:We are seeking a highly skilled Senior Project Manager to join our team at Worldwide Clinical Trials. As a Senior Project Manager, you will be responsible for leading cross-functional teams and overseeing the execution of clinical trials from start to finish.About Us:Worldwide Clinical Trials is a leading global contract research organization...
-
Clinical Trials Manager
2 days ago
Toronto, Ontario, Canada Ozmosis Research Inc. Full timeAbout the RoleOzmosis Research Inc. is a leading clinical trials management company that promotes a strong team environment and is seeking a highly skilled and experienced professional to join our team.We are seeking a Clinical Trials Specialist to participate in project management of clinical trials from protocol development and review through to...
-
Clinical Trials Manager
2 days ago
Toronto, Ontario, Canada Ozmosis Research Inc. Full timeAbout the RoleOzmosis Research Inc. is a leading clinical trials management company that promotes a strong team environment and is seeking a highly skilled and experienced professional to join our team.We are seeking a Clinical Trials Specialist to participate in project management of clinical trials from protocol development and review through to...
-
Clinical Trials Coordinator
4 days ago
Toronto, Ontario, Canada Ozmosis Research Inc. Full timeAbout the RoleOzmosis Research Inc. is a leading clinical trials management company that promotes a strong team environment and is seeking a highly skilled Clinical Trials Specialist to join our team.Key ResponsibilitiesProject Management: Participate in the management of clinical trials from protocol development and review to activation, follow-up, and...
-
Clinical Trials Coordinator
4 days ago
Toronto, Ontario, Canada Ozmosis Research Inc. Full timeAbout the RoleOzmosis Research Inc. is a leading clinical trials management company that promotes a strong team environment and is seeking a highly skilled Clinical Trials Specialist to join our team.Key ResponsibilitiesProject Management: Participate in the management of clinical trials from protocol development and review to activation, follow-up, and...
-
Toronto, Ontario, Canada Everest Clinical Research Services Inc Full timeAbout the RoleWe are seeking a highly skilled and experienced Senior Clinical Trial IWRS Monitor to join our team at Everest Clinical Research Services Inc. As a key member of our Clinical Trials Technology (CTT) unit, you will play a critical role in ensuring the accuracy and quality of data generated within our IWRS/IRT and eDiary systems.Key...
-
Toronto, Ontario, Canada Everest Clinical Research Services Inc Full timeAbout the RoleWe are seeking a highly skilled and experienced Senior Clinical Trial IWRS Monitor to join our team at Everest Clinical Research Services Inc. As a key member of our Clinical Trials Technology (CTT) unit, you will play a critical role in ensuring the accuracy and quality of data generated within our IWRS/IRT and eDiary systems.Key...
-
Senior Project Manager
6 days ago
Old Toronto, Ontario, Canada Worldwide Clinical Trials Full timeJob SummaryWe are seeking a highly skilled Senior Project Manager to join our team at Worldwide Clinical Trials. As a key member of our organization, you will be responsible for leading complex clinical trials projects from start to finish.About UsWorldwide Clinical Trials is a leading global contract research organization (CRO) that partners with...
