Job Description

About the Role

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
• Good computer literacy

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

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