TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence.
Our client, a leading Pharmaceutical company is hiring a Clinical Data Management on a contracting basis.
Work Location: Princeton
Summary:
- Provides clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projects
- Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects
- Responsible for end to end clinical data management activities and serves as a primary point of contact for internal and external study team members
- Provides strong quality and project oversight over third party vendor responsible for data management deliverables
- Takes a leadership role to gather content and integration requirements for EDC and close collaboration with partners supporting other data collection systems (eCOA, External Data, Safety Gateway)
- Enforces data standard conventions and quality expectations for clinical data per defined processes
- Authors, reviews/revises DM related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization
- Provides the relevant support and input to continuous improvement activities within clinical data management
- Provides support for CAPA implementation as required
Required Skills:
- Degree Requirements Bachelor's Degree required with an advanced degree preferred
- At least 5 years of relevant industry experience. Project management certification (e.g. PMP) is desirable
- Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors
- Sound knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management
- Strong knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills and well versed in industry trends and emerging technologies supporting data collection
- Strong project management; Exhibits expertise in metrics analysis and reporting methodologies
- Knowledge of submission requirements, [e.g. New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA)]
- Travel Required Yes, 5-10% Industry Conferences, Investigator Meetings, Regulatory Inspections (as needed)
Please contact me directly if you are interested in learning more about this opportunity or to discuss our referral program if you know anyone that may be interested.
Regards,
Dianne Weiss - provided by Dice