Clinical Data Programmer for EDC System
Logistics Manager; Director Level 40 hours per week for 2 months Remote, ideally from Watertown, MA preferred, or EST-based Travel Requirements: N/A Hourly rate: $85 - $150 About Clora's client is a clinical-stage biopharma company developing precision medicines to redefine the treatment of serious diseases across oncology, neurology, and immunology. The Client is looking for a Clinical Database EDC Programming consultant with proven expertise in Medidata RAVE. For the initial scope of this project, this consultant will set-up and program all of the data validation edit checks (600-800 edit checks) for 1 study. While this project will be billed hourly (actuals / Time & Materials), the consultant should anticipate 7 weeks for approx. 250 hrs in total. These estimated hours are subject to fluctuations based on the final number of edit checks and complexity of each edit check. Client anticipates a programming edit checks phase (~5 weeks), a Client's user acceptance testing phase (~1 week), and an updates phase (~1 week). This 7-week contract opportunity has the potential to extend, subject to project demands and mutual interest.
Responsibilities
- Program the initial edit checks for 1 clinical trial for the client's EDC system, Medidata RAVE (approx. 600-800 edit checks)
- Triage client's feedback during UAT and address updates
- Potential for future ongoing EDC updates and EDC builds
- Collaborate with client's internal clinical team and CRO partners
Ideal Candidate
- 7+ years in clinical programming for sponsor companies. Biotech/Pharma experience preferred.
- Ideal candidate should have a strong background in Clinical Programming with experience in Medidata RAVE. Responsibilities include overseeing database builds, creating edit checks, and ensuring adherence to industry standards to support clinical trials.
- Comfortable working in a fast-paced environment, be an efficient and independent problem solver, and be able to make and communicate decisions effectively.
- Oncology experience is preferred.