Responsibilities
- Main point of client contact and study team for all DM related matters.
- Execute all DM start-up activities, including the development and maintenance of eCRFs.
- Build process and lead all DM activities.
- Define and create data listings, summary table validation, data specifications, and process data transfers for statistical review.
- Ensure clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock.
- Set and create the data base and support the development of the study eCRF and then validate them, assessing the correct functionality of the eCRF developed, in compliance with the applicable quality validation standards.
- Coordinate and execute the coding activities (by using the known dictionaries, e.g. MeDRA, WHO etc), drug safety reconciliation and data review
- Reconcile Safety and Efficacy Data.
Qualifications
- Bachelors or Masters in Science/Nursing or related fields with 7+ years relevant data management experience in the CRO/pharmaceutical industry.
- Experience in oncology trials preferred.
- EDC Designing and UAT experience.
- Experience in Phase 1, 2, 3 clinical data management and database lock.
- Demonstrates knowledge of GCPs and protocol.
- Strong time management and prioritization skills to meet deadlines.
- Knowledge of ICH-GCP.
- Excellent Microsoft Office Skills.
Job Type: Contract
Pay: $145,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Vision insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Experience:
- Clinical Data manager: 5 years (Preferred)
Ability to Commute:
- Redwood City, CA 94063 (Required)
Work Location: Redwood City, CA 94063 (Hybrid). USA candidate only