Alkermes
Description
Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company 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 neurological disorders.
Roles and 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.
Qualifications
- Science background, BS or healthcare degree required, Masters preferred.
- Experience: 5+ years clinical research experience in a pharmaceutical/biotech, CRO setting.
- 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%.
