Clinical Trial Project, Manager

1 month ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Support Clinical Operations activities for assigned clinical studies including study planning, study start-up activities, protocol execution and study close-out as directed by and in collaboration with the Sr./Director Clinical Projects. Ensure global clinical studies are managed according to Good Clinical Practice, local regulations, guidelines, and Standard Operating Procedures (SOP). Responsibilities Ensure appropriate oversight and management of the Contract Research Organization (CRO)/vendors including : o Review and approve project plans (e.g., communication plans, risk management plans, project plans, safety management plans) in accordance with study objectives o Review status reports provided by CRO/service providers and highlight issues to facilitate decision making, including KPIs/Study Metrics o Participate in meetings review minutes, and provide support to the Director Clinical Projects so that CRO issues are proactively identified, communicated, and resolved in a timely manner o Review Monitoring visit reports to ensure homogeneous monitoring of the study and identify risks/trends o Conduct co-monitoring visits to ensure proper adherence to study protocols, develop/enhance site relations as needed which may include travel to a limited number of sites. o Supervise service provider/CRO’s country feasibility and site selection process in collaboration with Medical Affairs and Sr./Director Clinical Projects to identify and approve high quality investigators. Including review of preselection visit reports as applicable Contribute to the writing/updating/ review of essential documents such as ICF, Protocols/Amendments, Clinical Study Reports. Support for Investigator Meetings, including slide creation and presentation(s) Participate in study system set-ups including EDC, eCOA; perform UATs as needed Responsible for the negotiation of Site Budget and CTAs in partnership with CRO and DBV Legal Oversight of overall study budget and invoice review to ensure study remains within budget and invoices are approved on a timely manner. Work cross-functionally, using clinical operations expertise to ensure effective contributions, execution, and delivery of study activities ensuring a common understanding of activities across all stakeholders/line functions Support DSMB charter creation, attend/ prepare for DSMB meetings Provide clinical support for Data Management including functional review of data. Actively contribute, as needed to the preparation of clinical parts of IND/NDA/BLA/AMM/IMPD/DSUR dossiers Perform QC of TMF Mentor other members of Clinical Operations, including CTAs. Qualifications Minimum of B.A or B.S degree or higher degree (M.S., MPH, M.D., Pharm D, PhD etc.) Minimum 5-years-experience in a Clinical Operations role working on international/global Clinical studies within the Pharmaceutical/Biotechnology Industries or with a CRO, particularly with trial management experience. Experience/track record of having worked effectively in a multi-cultural environment Experience working in a matrix/cross-functional corporate organization Required Skills Good understanding of the drug development process and knowledge of Pharmaceutical Industry Knowledge and experience of GCP/ICH practice, and the regulatory and ethical environment of Clinical Studies Excellent organizational and management skills Scientific rigor, ability to analyze, interpret, write and report Good verbal and written communication skills 4C's Curiosity: Demonstrated desire to learn, explore, and understand new things. Courage: Ability to confront fear, uncertainty, and challenges with confidence and resolve. Collaboration: Working with others to achieve a common goal. Credibility: Builds trust, is reliable, acts with ethics and integrity. Must be available to work in the Warren County NJ office 3 days a week Seniority level

Seniority level Associate Employment type

Employment type Full-time Job function

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