We're currently working with an established Biotech company that is looking to add a Senior Clinical Data Manager to expand their growing team and small company team environment. They're currently looking for someone with previous Senior Clinical Data Management experience working with prior early phase/phase II clinical trial experience. Prior history working with Inflammatory Disease and Immuno-Oncology would be a bonus.
This Sr Clinical Data Manager position will:
- Represent Data Management at Study Team Meetings
- Lead the development of data edit checks specification and data listings
- Provide input of data-sets, validation plan specification, as well as performing data submission review.
- Develop or lead the development of the Data Management Plan for a clinical study.
- Perform reconciliation of data from external data sources against the clinical database
- Perform quick hypothesis generation and perform UAT testing
The Sr Clinical Data Manager should have:
- 8+ years experience in Clinical Data Management clinical trials in a Biotech/Pharma environment.
- Experienced working with Various EDC's (Medidata Rave, Oracle, Inform)
- Experience with Clinical development/trial conduct, including ICH-GCP
- Inflammatory Disease and Immun-Oncology experience (A Bonus)
- CRO Oversight/Vendor Management experience
- Experienced working in Study Start-up through Close-Out
Benefits/perks:
- Remote Opportunity
- Benefits; (Health, Dental, Vision)
- W2 Only, No C2C
