Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Manager, Clinical Research at our Cambridge, Massachusetts office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manager, Clinical Research working on the Oncology Global Medical Affairs Research team, you will be empowered to make meaningful contributions, and a typical day will include:
- Oversee and manage the operational planning and execution of phase 4 studies, including development of study protocols, project plans, budgets, and reports
- Contribute to vendor management, including contract negotiations, scope of work development, and oversight of study-related activities
- Contribute to the development of phase 4 trial management best practices within the Global Medical Affairs (GMA) oncology organization
- Manages Clinical Trial Working Group to ensure study goals and objectives are achieved and studies are executed within agreed timelines, budget, and in accordance with internal SOPs and GCP/GPP.
- Drives the cross-functional review of protocols/amendments, informed consent forms, case report forms, communication plans, training materials, and other trial-related documents, as necessary.
- Creates and manages study budget(s) by coordinating vendor and site budget negotiations, liaising with procurement/legal when necessary (e.g. Clinical Trial Agreement negotiation); establishing per patient cost assumptions; and anticipating ancillary costs. Develops and maintains tracking tools to ensure that trial costs are accurately predicted, tracked, and reported. Identifies cost savings.
- Manages or provides oversight to CRO(s) in preparation of study documentation (e.g. study manuals, monitoring plans, communication plans, investigator and patient-facing training materials); in investigator/site identification, feasibility, and start-up; in data management processes, inclusive of data entry and cleaning; in ensuring Trial Master File, maintained by CRO(s), is accurate and current.
- Monitors clinical trial progress according to study project plans.
- Consolidate and analyze data for trial progress reports for senior Oncology Business Unit (OBU) leadership.
EDUCATION, EXPERIENCE, BEHAVIORAL COMPETENCIES AND SKILLS:
- Bachelor s degree required in scientific or healthcare discipline; Master s degree preferred in scientific or healthcare discipline
- 5+ years in clinical development/research in the biotech/pharmaceutical industry and/or healthcare related field
- Thorough understanding of FDA, EMEA, ICH, and GCP guidelines, as well as a thorough understanding of cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, regulatory affairs, and legal affairs
- Working knowledge of MS Office software inclusive of Excel, Word, Project or other project management software preferred
- Ability to work effectively within or lead when appropriate cross-functional teams and in a matrix organization
- Ability to manage multiple priorities
- Experience in both interventional and observational studies preferred
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Empowering Our People to Shine
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please.