By clicking the Apply button, I understand that my employment application process with Takeda will commence and that I agree with Takeda s Privacy Notice, Privacy Policy and Terms of Use. Job DescriptionPOSITION OBJECTIVES: - Manages the operational components of investigator initiated sponsored research (IISR), including the review, approval, maintenance and close-out processes.
POSITION OBJECTIVES: - Works closely with field staff, local representatives, principal investigators and his/her staff to ensure appropriate submissions of all required study documents
- Ensures communication and information sharing occurs between cross functional groups and study sites as appropriate
- May contribute to preparation for, or participate in internal review and governance committees for IISR concepts and protocols and Study Progress Review Meetings
- Coordinates with investigator/site for study updates and receipt of publications/study report
- Obtains Confidentiality Agreements
- Assists with performing and/or follows up to gain additional information for Fair Market Value Assessments
- Manages the operational components of investigator initiated sponsored research (IISR), including the review, approval, maintenance and close-out processes.
- Budget review, payment schedule, and budget reconciliation at study closure
- Assist with study drug management and shipments
- Submits and maintains milestones in the IISR system
- Contributes to creation of study drug and budget projections
- Provides training to internal cross-functional colleagues
EDUCATION, EXPERIENCE, BEHAVIORAL COMPETENCIES AND SKILLS: - BS degree with 3+ years of progressive experience in Medical Affairs and/or Clinical Operations
- Thorough understanding of FDA, ICH and GCP guidelines as well as an understanding of cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, regulatory affairs, legal, clinical supply, corporate communications, medical affairs and commercial
- Excellent interpersonal and negotiation skills
- Strong verbal and written communication skills
- Proven problem solving and decision making skills
- Ability to work in a team environment and independently
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. LocationsBoston, MA Worker TypeEmployee Worker Sub-TypeRegular Time TypeFull time |
