Alkermes · 3 days ago
Clinical Trial Manager
Greater Boston
Full-time
Hybrid
Senior Level
$146K/yr - $160K/yr
5+ years expAlkermes is a global biopharmaceutical company focused on developing medicines for complex psychiatric and neurological disorders. The Clinical Trial Manager will oversee, coordinate, and execute clinical trials, ensuring adherence to timelines and budgets while collaborating with various stakeholders to meet recruitment and study objectives.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Clinical project team member: works closely with the Sr. CTM and/or Clinical Program Manager and is responsible for oversight, planning, and execution of assigned clinical studies, timelines, and key deliverables
Works closely with Clinical Outsourcing on selection of CROs and vendors, RFI, RFP and bid defenses, and contract & budget negotiations. Participates in CRO and other vendor selection along with CPM and Director Clinical Outsourcing
Oversees and works directly with CROs, vendors, field monitors and other partners. Establishes relationships with investigators, study coordinators, site personnel and other external key stakeholders
Accountable for developing and managing study budgets and financial reporting, including month end and quarterly flash reporting, financial reconciliation, accruals, and re‐forecasting, with Clinical Outsourcing, Finance and Project Management
Responsible for study status and timelines, and feeds data into performance metrics reporting for assigned clinical projects
Works with Patient Recruitment department and is responsible for overall recruitment strategy, enrollment projections, and meeting established targets
Coordinates and/or participates in development of clinical study documents including ICF, monitoring plans, recruitment plans, and other program/study related documents
Leads and participates in internal cross‐functional clinical team meetings; serves as main point of contact for study‐level status updates
Presents at clinical team meetings and other forums on study progress
Works with Study Start‐up and coordinates study start‐up activities including feasibility, investigational product and materials preparation, trial master file set‐up, CRFs, regulatory documents, and site contracts in conjunction with other relevant departments
Participates in database creation and user acceptance testing, provides input for edit checks, monitoring guidelines, and data cleaning activities between study sites, data management and field monitors
Participates in SOP development, process mapping, training of junior CTMs and CTAs, and other departmental activities
Direct line management and supervision of CTAs. Responsible for performance reviews and supporting professional development for direct reports
Qualification
Required
Science background: BS or healthcare degree required, Masters preferred
Experience: 5+ years clinical research experience in a pharmaceutical/biotech, CRO setting
Preferred
Monitoring experience, a plus
Strong knowledge and understanding of GCP/ICH guidelines for conducting clinical trials
Strong leadership, interpersonal, organizational, and multi-tasking skills
Excellent attention to detail and problem solving skills
Ability to work effectively in a team setting
Travel domestic and international – up to 25%
Benefits
Annual performance pay bonus
Competitive benefits package
Company
Alkermes
Alkermes is a biotechnology company that develops, manufactures and commercializes medicines for the treatment of chronic diseases.
1001-5000 employees
H1B Sponsorship
Alkermes has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (32)
2024 (20)
2023 (21)
2022 (14)
2021 (27)
2020 (22)
Funding
Current Stage
Public CompanyTotal Funding
$250MKey Investors
Primecap Management
2017-11-20Post Ipo Equity
2014-01-13Post Ipo Equity· $250M
2011-09-16IPO
Leadership Team
Craig Hopkinson
EVP, Research and Development, CMO
Recent News
2026-01-03
2025-12-30
Genetic Engineering News
2025-12-24
Company data provided by crunchbase