Study Manager at Whippany

Job Description

Title: Study Manager in Whippany, NJApprox Contract Duration: Target 1 year.Description: Manages and is responsible for all activities related to complex phase I and extended phase I/IIa clinical trials from the approved study concept to the clinical study report. Manages the selection and oversight of External Suppliers (e.g. site management and monitoring CROs, Central Labs, central ECG reading center, etc.). Manages all Study Team activities as defined per SOPs/OIs and ensures the organization of regular Study Team meetings. Develops and manages budget, timelines and quality of the study and its deliverables. Responsible for forecasting and tracking of study costs. Ensuring all relevant IT-systems are updated with current and accurate information (e.g. IMPACT) Responsible for all start up activities e.g. CRO selection, CRF development, drug forecasting, study manuals, monitoring plan, data management plan, definition of end points, selection of safety and efficacy assessments, recruitment planning and oversight. Write protocols and amendments in collaboration study team members Responsible for feasibility and site selection to meet study enrollment and timelines. Responsible for developing the total external study budget and accountable for providing monthly and yearly estimates, tracking study budget, initiating payments, providing monthly information to controlling, OPL, CPL, identifying budget/estimate issues and proactively developing a plan for resolving study finance issues. Tracks and compiles patient enrollment, data cleaning progress and overall study progress and ensures study timelines are met Responsible for training and oversight of CROs to ensure compliance with timelines and budget. Develops appropriate study related training for monitors and site personnel according to GCP and standards Ensure accurate data collection, protocol adherence, patient safety, PK, PD, biopsy sample integrity and GCP compliance Point of contact for managing/answering questions related to trial procedures and patients eligibility Ensures clinical trial registry and results posting, manages the study insurance according to required timelines Ensures set-up, maintenance and Quality Control of the study Trial Master File (TMF) Conducts lesson learned at any point in time when requested by management or any Study Team member and mandatory at study closure. Escalates severe deviations to a key parameter (i.e. recruitment, timelines, patient safety, protocol compliance, data collection/cleaning, budget) after discussing and in alignment with the Study Team to CPL and functional manager CHI

Job Requirements

 
Country: USA, State: New Jersey, City: Whippany, Company: InVentiv Health.