Job Description
Job Description
Clinical Data Manager who will work collaboratively with vendor Project Managers and Clinical Data Managers to assure that Data Management functions are performed in compliance with regulations and according to study protocol and the Study Data Management Manual (DMM). You will work with involved parties to assure that DMM is prepared according to company SOPs and in compliance with Company's data standards.
Serve as primary DM contact for assigned studies, including representation on project teams and working with CROs performing data management tasks for assigned study.
Coordinate, lead and perform clinical data management activities for assigned studies in accordance with Regeneron's SOPs and policies and practices including, not limited to:
Monitoring data clean-up process performed by CROs from study start-up through data archiving.
Providing data for analysis.
Coordinating activities including: medical coding; data validation checks and database snapshot.
Prepare and distribute project status reports to project team and management.
Function as DM team leader responsible for ensuring databases are validated and ready for transfer and/or analyses in accordance with Regeneron SOPs.
Create and maintain project documentation, including, but not limited to, Data Management Manual, CRF Completion Guidelines and validation specifications, and work instructions for assigned projects. Designs and modifies CRF.
Responsible for the initiation and approval of the building, testing and validation of clinical databases, subsequent changes in clinical databases and data validation activities.
Contribute to upkeep Regeneron DM outsourcing strategies and long-term relationships with outsourcing partners with objective of ensuring data quality and efficiencies through data and process standardization.
Work with study team and coordinates all data management functions. Manage coordination of CRO data manager and project team to ensure that tasks are performed according to policies and procedures.
Additional Skills & Qualifications
Bachelors Degree
7+ years of experience within Industry
EDC experience
great communication skills
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.