Full Job Description
Office Based USA (Whippany, NJ)
Experience in Women's Health Studies
Covance is seeking a Study Manager to work in Whippany, NJ. In this role, the selected candidate will manage and be responsible for all activities related to global and/or local clinical trials from the study concept to the clinical study research report; Lead the Study Team, from the request of core Study Team members to study close-out contributes to the Study Concept development with regard to its operational aspects, if assigned already; develops the comprehensive overview and operational plans for the study by developing and maintaining the Study Plan.
Additionally, the selected candidate will be responsible for the following: Contributes to risk management activities of GCT and responsible for study specific oversight and risk mitigation activities as described in the Study Plan. Supports the strategic study feasibility and manages operational study feasibility conducted by country organization to determine study feasibility and final country selection based on the feasibility summary, develops study timelines, milestones, outsourcing plan and proposed external study budget in close collaboration with the study team assists in the development of the core study documents and processes. Assists in the preparation of the study protocol. Responsible for developing the total external study budget and accountable for providing monthly and yearly estimates. Responsible for tracking study budget, initiating payments, forecasting and providing monthly information to controlling and GCL, identifying budget/estimate issues. Verifying all relevant IT-systems are updated with current and accurate information (e.g. IMPACT). Identifies, implements, leads and manages a cross-functional core Study Team for the duration of the study, working with functional line management to identify team members and resolve issues. The Core study team members include: Study Medical Expert, Study Statistician, Study Data Manager and the Study Lead Monitor disseminates relevant information to team members in effective and timely manner. Represents the study team as a member of the Global Clinical Team. Manages, tracks, and is responsible for verifying ongoing study activities, study execution and timelines are met. Tracks and compiles patient enrolment, data cleaning progress and overall study progress. Assesses and analyses study information for variances and takes necessary actions within his/her responsibility to resolve variances, if necessary. Initiates action with functional heads to resolve variances. Develops appropriate study related training for study team representatives (in particular for Monitors) and site personnel according to GCP and BHP global development standards to confirm quality and requirements necessary for global regulatory approvals and marketing needs are met. Act as Responsible Outsourcing Person in outsourced studies and manages the selection and oversight of other external suppliers (e.g. Central Labs, central ECG reading center, etc.). Selects and develops contract specifications for external supplier in collaboration with global strategic sourcing manager. Responsible for defining outsourced tasks, developing outsourcing plan, training and managing external suppliers to confirm compliance with timelines and budget. Identifies milestone achievements to initiate payments to external suppliers. Advises and manages Study Committees and external expertise. Education/Qualifications: Required: University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution
Master or other advanced degree
PMP certification Experience: Minimum Required:
7 – 8 years of relevant healthcare experience and 3 years clinical operations experience in the Pharmaceutical Industry
1 – 2 years of Monitoring and/or Clinical Trial/Study Management experience preferred.
Responsible for management of Phase II – IV global clinical trials, requiring an in-depth knowledge of Good Clinical Practice (GCP), Federal Regulations and International Regulations (International Harmonization Committee-ICH Regulations).
Women's Health experience required