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Clinical Trial Manager - Waltham, United States - Alkermes
Description
Job DescriptionPosition 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 OutsourcingOversees 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%
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.#LI-MB1
About Us
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.
Headquartered in Dublin, Ireland, Alkermes has a research and development center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.
For more information, please visit Alkermes' website atAlkermes, 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, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
Alkermes is an E-Verify employer.#J-18808-Ljbffr
