Experienced Manager, Clinical Data Management (Emerging Pharma) – Top $/Direct Hire
Our client, an emerging clinical stage Pharmaceutical company in the RTP area, is actively recruiting for an experienced, knowledgeable and hands-on Clinical Data Manager to lead DM activities.
This is a growing company that focuses on developing and commercializing drugs in the rare disease space. We are seeking a skilled and highly capable Data Manager to drive all DM activities for the Biometrics team. Company will pay excellent wage to attract and retain the right person.
This role will involve leading and performing data management activities to support ongoing clinical trials. This will include ensuring data management activities for clinical trials are completed in a timely and accurate manner and by providing oversight of CROs performing core data management functions. Experience overseeing outsourced vendors, as well as the ability to do the DM work brought inhouse, will be needed.
Specific responsibilities will include:
- Overseeing data integrity, quality, and consistency at database lock
- Developing and reviewing clinical trial and data management documents (protocols, CRFs, edit checks, data management plans)
- Ensure accuracy and consistency of clinical trial data, SAE data fields and content and data systems
- Oversee and support CRO partners, to include technical review, evaluation and selection
- Along with Statisticians, prepare datasets for in-house analyses and abstract submissions
- Contribute to the compilation and review of datasets for Regulatory Submission
- Develop SOPs for Data Management function.
Much of the data management work is outsourced to CROs, however some of this work will be brought in-house. Quality execution will be dependent upon this Data Manager’s ability to effectively manage the sponsor/vendor relationship. Outstanding project management skills will be critical.
Additional DM responsibilities could include:
- EDC and IWRS user acceptance testing
- Data cleaning
- Data quality review
- Identification of data discrepancies
- Database lock
The ideal candidate will offer a BS in a scientific discipline and 5+ years of experience handling data management functions within the pharmaceutical /CRO industry, to include 2+ years in a Lead Data Management role in phase I-IV clinical trials. Experience working in a Pharma company overseeing CRO partners is a plus, but not required.
Experience will the following will be needed:
- CRF development
- Database design
- EDC systems
- Data management plans
- Data cleaning
- Implementation of CDISC standards.
- Proficiency in SAS to review and work with clinical datasets.
Further, this is a young company that is still developing its Data Management policies and practices. The right candidate will enjoy helping to create a Best Practices approach to Data Management. Finally, given the growth and pace, experience in a start-up, emerging setting, and the demonstrated ability to help build structure, practices and standards for a high quality data management group, is essential.
This is a direct hire full-time, office based position and a great opportunity for a skilled professional who seeks a challenging and rewarding position. Please forward resume for prompt consideration. Local candidates only.