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)
Ensure effective oversight and management of Contract Research Organizations (CROs) and vendors by reviewing and approving key project documentation in alignment with study objectives, monitoring status reports and study metrics to support informed decision-making, participating in meetings and supporting the Director of Clinical Projects to proactively identify and resolve issues, ensuring consistent study monitoring through review of visit reports and co-monitoring activities, and overseeing country feasibility and site selection processes in collaboration with Medical Affairs to identify and approve high-quality investigators.
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.

Requirements

+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
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.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Clinical OperationsGood Clinical Practice (GCP)Clinical Study ReportsElectronic Data Capture (EDC)eCOASite Budget negotiationData ManagementIND/NDA/BLA/AMM/IMPD/DSUR preparationQuality Control (QC) of TMFProtocol execution

Soft Skills

Organizational skillsManagement skillsAnalytical skillsCommunication skillsMentoringCross-functional collaborationProblem-solvingCultural awarenessTeamworkPresentation skills