Sr Clinical Trial Manager/Clinical Trial Manager II
Alkermes plc is a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to develop innovative medicines that improve patient outcomes. The company has a diversified portfolio of more than 20 commercial drug products and a substantial clinical pipeline of product candidates that address central nervous system (CNS) disorders such as addiction, schizophrenia and depression. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Mass. and manufacturing facilities in Athlone, Ireland; Gainesville, Ga.; and Wilmington, Ohio. For more information, please visit Alkermes' website at http://www.alkermes.com/.
Position Summary: Responsible for coordination and execution of clinical trials in support of large Phase III global clinical program
Duties and Responsibilities:
- Clinical project team member: works closely with the Clinical Program Manager and is responsible for oversight and execution of assigned clinical studies, timelines, and key deliverables.
- Clinical Study Team leader: Coordinates and participates in internal and external cross-functional clinical team meetings; serves as main point of contact study-level status updates.
- Provides oversight and mentorship to Clinical Trial Associate(s) assigned to trials
- Tracks study status and timelines and feeds data into performance metrics reporting for assigned clinical projects.
- Provides input and participates in development of clinical study documents including protocol, ICF, monitoring plans, recruitment plans, and other program/study related documents.
- Participates in selection of CROs and vendors, RFP process, contract and budget negotiations.
- Works closely with Outsourcing and Study-Start-up Teams: Responsible for coordinating study start-up activities including feasibility, study product and materials preparation, trial master file set-up, CRFs, investigational documents, and site contracts in conjunction with relevant departments.
- Works directly with CROs, vendors, investigators, monitors and other external partners.
- Responsible for developing, maintaining and tracking study budgets and financial reporting, including invoice and PO management/reconciliation, accrual tracking and reporting, and re-forecasting, with Finance and Project Management.
- Supports tasks related to data management, participates in database creation and user acceptance testing, input for edit checks and monitoring guidelines, data cleaning activities between study sites, data management and field monitors.
- Supports Clinical Biometrics in coordination of receipt of all ancillary data e.g. safety lab data, analytic lab data, IVRS randomization data to ensure data is received at the time of database lock.
- Participate in process improvement and development: SOP development, training, process mapping, and other departmental activities.
Education/Skills and Experience Requirements:
- Science background BS or healthcare degree
- Experience minimum 3-5+ years in a pharmaceutical/biotech, CRO setting, monitoring experience a plus for Clinical Trial Manager II
- Experience minimum 7-10+ years in a pharmaceutical/biotech, CRO setting, monitoring experience a plus for Sr. Clinical Trial Manager
- Strong knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials
- Strong interpersonal, organizational, and multi-tasking skills
- Excellent attention to detail and problem solving skills
- Ability to work effectively work in a team setting
Physical Demands and Work Environment:
● Travel domestic and international – up to 20%
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law