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.
Reporting Relationship: Vice President, Research and Development Operations
- 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.
- May Mentor other team members.
- Perform other duties as requested by the senior management.
- Proven leadership skills, executive presence, maturity, emotional intelligence, and written/oral communication skills.
- Demonstrated skills working within a matrix environment.
- Ability to work collaboratively with others within and external to the company, including investigators, CROs, vendors and team members in parent company in Japan.
- Interpersonal skills and influence to accomplish work without formal authority and to ensure optimal team performance.
- S./M.S./Ph.D. in a related life science discipline is preferred.
- Thorough understanding of the oncology arena.
- Minimum of 3-5 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.
- Sound judgment, problem solving, leadership, and collaboration in selecting methods and techniques for obtaining solutions to problems.
- Familiarity with the design and conduct of clinical trials and project management in relevant therapeutic areas
- Experience evaluating outcomes of clinical trials and basic knowledge of clinical trial outcome standards.
- Strong analytical skills with a data driven approach to planning, executing, and problem solving
- Working knowledge of current global regulatory requirements and guidelines for clinical trials.
Job Location: Cambridge, MA
Please send resumes to firstname.lastname@example.org