Clinical Trials Manager Job in Weston 02493, Massachusetts US
It is important that this individual have Clinical Trial Manager experience, and preferably global experience and has worked with Asia Pacific.
As a key member of the clinical operations team , this individual will play a critical role in advancing our hemophilia programs on a global basis with the overall goal of significantly improving treatment options for patients and their families. Relying on a strong understanding of effective clinical trial management, this individual will translate program strategy into actionable clinical operations plans and then ensure cross-functional execution.
Key responsibilities include:
• Plans program feasibility, developing strategies for country selections, CRO/vendors use and evaluations and planning for contingencies for a global Hemophilia program.
• Establishes effective working relationships with study investigators and coordinators to ensure that timelines and accrual targets are met and site processes comply with SOPs, Regulatory regulations and ICH/GCP guidelines.
• Coordinates all relevant Clinical Development activities/documents related to Regulatory Submissions (e.g., IB, IND, Annual Reports, BLA, NDA or other regulatory filings).
• Builds strong relationships with individuals and groups across Biogen Idec to identify opportunities for sharing of best practices and to align activities and process where appropriate.
• Provides input into creation of program budget and manages Clinical Development elements with an emphasis on identification, resolution and/or escalation of discrepancies.
• Interacts frequently with external partners, including expert panels, physicians and investigators, CROs, contract laboratories, advisory committees, clinical trial consultants, and cross-functional counterparts from development partner.
Typically requires at least 5+ years of global drug development with experience managing clinical projects within time, budget, and quality expectations.
•Experience in Hemophilia and clotting disorders. hematology/oncology clinical research and development very desirable.
•Prior experience with complex, Phase3 global clinical trials is required.
Candidate must have very strong project management experience leading global clinical project efforts
NDA/BLA or MAA experience desirable, particularly within an orphan/rare disease therapeutic area.
•Thorough knowledge of GCP, ICH guidelines and awareness of global regulatory requirements/differences for clinical development.
•Detail and process oriented, with excellent project management skills, including risk assessment and contingency planning.
•Demonstrated leadership, communication, and organizational skills, along with problem solving, conflict resolution, and team building skills.
•Proven excellence in cross-functional matrix and/or cross-cultural partnership setting preferred.
Education Bachelor’s degree or equivalent combination of education/experience in science or health-related field required