Lead Clinical Data Manager

Smith Hanley Consulting Group is currently looking for a Lead Clinical Data Manager in the Bridgewater, NJ area to service a contract through the end of the year at a major pharmaceutical company. Job duties include:  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.   Skills sets and experience required:  Candidates must have at least two years of senior/lead clinical data management experience within the pharmaceutical industry.  Experience in CRO management required.  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.  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 required:  BS Degree in Life Science or equivalent Nursing/medical background. Reference Code:3019584