Clinical Research Associate, Global Medical Affairs Oncology

Takeda Pharmaceutical Company • Cambridge, MA

261d • $28 - $44 • Remote

About The Position

As a member of Takeda Oncology, your work will contribute to our bold, inspiring vision: We aspire to cure cancer. Here, you'll build a career grounded in purpose and be empowered to deliver your best. As part of the Global Medical Affairs Oncology Evidence Generation team, you will report to the Lung Evidence Generation Lead/ Medical Affairs Company Sponsored (MACS) Program Leader and work with various departments and functions.

Requirements

• Bachelor's degree in a science and/or engineering field preferred
• 2+ years of clinical research experience
• Thorough understanding of FDA, EMEA, ICH, and GCP guidelines preferred
• Understanding of cross-functional clinical processes including data management, biostatistics, budgeting, medical writing, drug safety, regulatory affairs, and legal affairs
• Working knowledge of MS Office Software including Excel and Word
• Ability to manage multiple priorities

Responsibilities

• Assists with study tasks under the supervision of Investigator-Initiated Research (IIR), Externally Sponsored Collaborative Research, and MACS Study Leads
• Works closely with field staff, local representatives, principal investigators and his/her staff to ensure appropriate submissions of all required study documents
• Responsible for processing and facilitating activities associated with Concept, Protocol and Protocol Amendment Reviews
• Manages internal study designated website/database systems, including but not limited to: business requirements, administration, and processes
• Ensures communication and information sharing occurs between cross functional groups and study sites as appropriate
• Coordinates with investigator/site for study updates and receipt of publications/study report
• Study drug management and tracking
• Submits and maintains purchase order requests, supplier registrations, and invoices in central finance system for IIR, Collaborative Research, and MACS
• Assists in the preparation and documentation of the Fair Market Value (FMV) Analysis of research budgets for IIR, MACS, and Collaborative Research studies
• Assists with budget management and reporting for GMAO Evidence Generation activities
• Coordinates the execution of Confidentiality Agreements and contracts via a legal tracking system

Benefits

• Medical, dental, vision insurance
• 401(k) plan and company match
• Short-term and long-term disability coverage
• Basic life insurance
• Tuition reimbursement program
• Paid volunteer time off
• Company holidays
• Well-being benefits
• Up to 80 hours of sick time per calendar year
• Accrual of up to 120 hours of paid vacation for new hires

What This Job Offers

• Job Type: Full-time
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree