This position is responsible for supporting data management activities on clinical studies. This includes, but not limited to, reviewing Case Report Form (CRF) and Data Validation process (including data reconciliation, query generation and resolution, and manual data review of listings), according to study specific Data Management Plan (DMP) and Standard Operating Procedures (SOP) as well as study protocol.
This position will report to the Sr. Manager, Clinical Data Management or higher.
- Support Data Managers on both in-house (RAVE) and outsourced studies through subject data reviews, data listings, identifying data discrepancies, verifying data query resolutions including resolution of data issues from clinical and Statistical groups.
- Assist with development or review of study specific DMP, CRF/eCRF development, edit check specifications, and other data management documents.
- Actively participate in study database setup and testing.
- Assist in other quality control activities related to clinical data management.
- Generate data listings and ad hoc reports to assist in data review.
- Must be proficient on all related regulations, GCP, and Good Clinical Data Management Practices
- Flexibility and agility to adapt to changing scope of work, able to propose thoughtful solutions to challenges and issues, proactively implement solutions, and communicate effectively with colleagues
- Experience with Clinical Data Management Systems related to EDC studies: RAVE (required), Inform, JReview and BOXI. eSource a plus.
- Incumbent must be organized, attention to timeline and details, good communication skills (verbal and written).
A BA or BS degree in a health-related field preferred (or equivalent work experience) with 3-5 or more years of related experience in clinical data management in the pharmaceutical/biotechnology industry or equivalent