Sr. Clinical Trial Manager (Sr. CTM)
Department: Clinical Development
Reports to: Director, Clinical Development Operations
Location: Woburn Office
Summary of Job Description:
The Sr. Clinical Trial Manager (Sr. CTM) is responsible for the planning, implementation and conduct of large, global Phase I-III clinical trials, or multiple smaller early-phase studies. The Sr. CTM is expected to provide leadership and guidance in managing clinical activities at the project level. This includes meeting company and regulatory requirements according to written processes and procedures, timelines, quality and budget.
- Manage clinical studies from concept through Clinical Study Report completion
- Manage study execution, including management and oversight of CROs, vendors and consultants that are involved with the clinical trial and program
- Develop and track study timelines, milestones, budget, and quality metrics
- Organize, lead and manage the clinical project team to ensure adherence to overall project timelines and budget; lead regularly scheduled cross-functional study team meetings with internal and external resources
- Ensure GCP and regulatory compliance is maintained
- Assist in preparation and review of study-related documents, including study protocols, informed consents, Investigator Brochure, study manuals and plans.
- Participates in CRO and other vendor selection, negotiation and management, including monitoring of associated budgets and contracts.
- Manage clinical trial budgets, providing ongoing financial reporting and projections to finance group.
- Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews.
- Participate and respond to Quality Assurance and/or regulatory authority inspection audits.
- Proactively identifies and resolves issues, and participates in process improvement initiatives as required
- Manages, mentors, and develops direct reports
- Maintains professional expertise through familiarity with therapeutic area and clinical research literature
- Aides in the training and development of all clinical staff members
- Performs other duties as assigned
- Bachelor’s degree in health sciences or related field
Experience and Skill Requirements
- Five or more years’ experience in study management; 1-3+ years of clinical study management experience in global clinical studies
- Experience in management of CROs, vendors and consultants
- Experience leading cross-functional teams
- Able to collaborate effectively with the study team, cross-functional team members and external partners (including investigator and site staff)
- Solid understanding of FDA and other regulatory requirements that may impact global clinical studies
- Thorough knowledge and application of GCP and ICH guidelines, current FDA and other regulatory requirements for clinical trial management
- Therapeutic experience in oncology
- Proficient written and verbal communication skills
- Computer skill should include proficiency with Microsoft Office software
- Position may require some travel
EEO & Employment Eligibility:
Replimune is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, ancestry origin, disability or veteran status. Replimune also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
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