Data Manager needed in Bridgewater, New Jersey!

Data Manager needed in Bridgewater, New Jersey!

RESPONSIBILITIES:

- Candidates must have at least two years of senior/lead clinical data management experience. Experience should include DM activities from start-up of clinical trial to database lock: protocol review; case report form design; development of corresponding CRF completion guidelines; database design (general concepts); development of annotated CRF; development of data management plan which including data validation checks, coding guidelines, serious adverse event reconciliation, external data reconciliation, quality control of database.
- Also, experience in CRO management is required. Candidates should be able to plan, coordinate, conduct, and oversee data management (DM) activities of USMA studies subcontracted to a CRO/ARO, in accordance with agreed timelines and in compliance with quality and standards.
- Responsibilities will include but are not limited to: assist in selection of vendors; development of scopes of work; review clinical data transfers to ensure data integrity and conformance to established specifications; review and approve all DM deliverables from vendors; collaborate with appropriate functions to assure that required study documentation filing/archiving steps are completed.
- Review internal SOPs and processes. Provide input on revising process/SOPs/standardization efforts. Collaborate with external functions to oversee data management audits and assure that appropriate measures are implemented to address audit findings if needed.

REQUIREMENTS:

- Candidate must be experienced in a lead role
- Candidate should be able to work independently with little supervision
- Excellent knowledge of data management systems and processes
- Strong knowledge of clinical research procedures and FDA regulations
- Strong communication and interpersonal skills; ability to work effectively in a cross-functional environment
- Attention to detail and strong organizational skills
- Education: Bachelor of Science Degree in Life Science or equivalent Nursing/medical background preferred 2+ years of senior/lead data management experience in pharmaceutical industry
- Experience in CRO management required