Clinical Trial Manager

Overall Summary: Responsible for oversight, coordination, and execution of clinical trials in support of clinical programs in Phases I‐IV of development.

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

Basic Requirements: 

• Science background: BS or healthcare degree required, Masters preferred
• Experience: 5+ years clinical research experience in a pharmaceutical/biotech, CRO setting

Preferred Requirements: 

• 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%

Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work.

 

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Why join Team Alkermes?

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.

Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified