Responsible for the planning, implementation, execution and management of multiple clinical studies by overseeing day-to-day operations and directly managing outside Clinical Research Organizations.
Represents and leads the study team to design, develop and deliver the clinical study to agree upon timelines.
Leads planning and communication with cross-functional teams to ensure proper execution and conduct of the clinical trial; generates quality clinical data.
Serves as primary contact and resource for CRO and vendor personnel in overarching functions as well as team members in parent company.
Provides oversight and management of CROs, consultants and vendors.
Oversees and monitors the management of clinical studies ensuring they are conducted in compliance with the agreed study plans through regular CRO and/or investigator site contact.
Monitors progress of clinical activity and reports on the progress of assigned clinical trials including budget and timelines.
Monitors the status of clinical data collection of assigned clinical trials.
Prepares potential investigator site lists and assists with their evaluation for inclusion in the study.
Prepares and reviews study-related documents when required.
Reviews and approves study-related plans generated by CROs and vendors, and ensures the documentations are in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies.
Participates in the review and finalization of clinical study-related documents such as protocols, protocol amendments, clinical study reports (CSRs), regulatory submissions and other publications as required.
Participates in meetings – i.e. Study Team Meetings, Investigator Meetings, Monitors’ workshops and CRO Training.
Reviews correspondences and monitoring reports relating to the studies.
Prepare and deliver program/study updates.
Coordinates the delivery of clinical trial supplies in collaboration with CRO and other team members.
Monitors budget for clinical study, and review budgets and contracts with CROs, vendors and investigator sites (as applicable) in collaboration with Finance and Legal team.
Requests and critically evaluates proposals and change orders from CROs, vendors and investigator sites (as applicable).
Provides input into contracts, work orders and/or change orders.
Manages escalation of study related issues and communicates as appropriate with management and other R&D functions.
Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight.
Ensures assigned studies adhere to all applicable regulations and requirements.
Provides input as the subject matter expert for the assigned studies during regulatory inspections.
Establish collaborative and productive relationships with parent company, internal/external partners and relevant affiliates.
Evaluates issues found in clinical studies, communication and oversight of CROs and vendors, and suggests and implements solutions and mitigations as required.
Evaluate CRO and vendor performance and support the improvement initiatives.
Participate in the preparation, review, updating and training of SOPs.
Maintain knowledge of oncology therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities.
B.S./M.S./Ph.D. in a related life science discipline is preferred.
Thorough understanding of the oncology arena.
Minimum of five years of industry experience in clinical drug or program development or equivalent academic experience in clinical trials.
Strong experience facilitating project team meetings, cross-functional communication and decision making, and ensuring alignment with internal and external stakeholders
Strong attention to detail and the ability to establish priorities, schedule and meet deadlines.