Senior Study Site Engagement Manager
Takeda Pharmaceutical
Danvers, Massachusetts
senior
engagement
manager
team
sse
oversight
engagement
monitoring
lead
cra
startup
management
people
November 22, 2022
Takeda Pharmaceutical
Danvers, Massachusetts
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- Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine?
- Join us as a Senior Study Site Engagement Manager in our Cambridge, MA office or based remotely reporting to the Study Site Engagement Team Lead.
- At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company.
- To do this, we empower our people to accomplish their potential through life-changing work.
- Certified as a Global Top Employer, we offer stimulating careers and work toward excellence in everything we do.
- We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.
- Here, you will be a necessary contributor to our inspiring, bold mission.
- As the Senior Study Site Engagement Manager (Sr. SSEM) is the regional representative of Takeda for site relations and Clinical Research Associate (CRA) engagement, supporting study teams with startup and recruitment and fulfilling sponsor oversight activities.
- You will coordinate operational aspects of Takeda Sponsored studies from Study startup through CSR within the assigned region or countries across Takeda therapeutic areas.
- You will engage and provide additional value by advising and educating study sites, while building sustainable relationships with investigators and study site personnel.
- You will support country and site identification, feasibility, site selection, study recruitment strategies, and reduce barriers at the direction of Clinical Programs.
- The Sr. SSEM will work with field monitoring CRAs, local Clinical Research Organization (CRO) team, and global study team and supports Takeda study teams in their Sponsor Oversight responsibilities.
- You will also contribute to a partnership between Takeda study teams, study sites and the CRO, and communicate with regional/country Medical Affairs (MA) and provide and collect updates on site status.
- Early engagement - Country and Site Feasibility
- Support the Study Site Engagement Lead (SSEL)/ SSE Program Lead (SSE PL) with the development of study site list for feasibility - site selection and helps track feasibility progress and escalations for SSEL/LOC support.
- Report any discrepancy on CRO feasibility progress to SSEL/SSE PL.
- Communicate with regional/country SSEL, MA, local Clinical Operations team and CRO staff for site identification and feasibility support in alignment with global study team.
- Attend qualification visits (PSSVs (Pre Study Site Visits
- as requested or agreed upon with the SSEL.
- Help to follow up with country MA, local Clinical Operations team and keep track on country and site selection activities.
- Study Startup Phase - Post Site Selection to Site Initiation
- Support the SSEL/SSE PL in tracking startup hurdles escalated to the team and their resolution to ensure SIVs and site activations are achieved as planned.
- Attend and support site initiation visits (SIVs) and oversee CRA during SIVs agreed upon with the SSEL.
- Help SSEL/SSE PL in tracking resolution of any follow-up item needed post SIV until resolved by site or CRO/Takeda study team.
- As invited, attends Investigator Meetings (in the region) and liaises with sites / CRO.
- Enrollment and Study Conduct Phase
- Support recruitment strategy and activities when targets are not met (e.g. use of PR&R materials, booster visits, phone calls).
- Work with local CRO team throughout the lifecycle of the study.
- Help coordinate the SSE booster visit requests received from SSE PL.
- Help to maintain study specific trackers (booster visits).
- Sponsor Oversight Activities
- Review Site Monitoring Visit reports and in-house important documents.
- Arrange Takeda Monitoring Oversight Visit (MOV) related activities with the CRO CRAs.
- Partner with service provider to schedule the MOV. Provide relevant information and documentation to service provider to prepare for the visit.
- Schedule follow-up meeting with service provider and Takeda study team after the visit.
- Help SSE team keep track of items the function will need to address on future interaction with the site.
- Provide support to clinical studies to ensure study deliverables are met.
- Activities will vary depending on the needs of the clinical program or study phase and following the level of service agreed.
- Engage and provide additional value by advising and educating study sites, building sustainable investigator and site relationships, and maintaining site communication throughout the study.
- Support Takeda study teams in their Sponsor Oversight responsibilities through reviewing monitoring reports and arranging MOVs with the CRO-CRA during routine monitoring visits.
- Bachelor's Degree or international equivalent is required.
- A clinical or advanced degree (RN, MS, MA, MBA, or PharmD), preferred.
- 7+ years of relevant clinical research experience with a CRO or pharmaceutical company working on global clinical studies or clinical study site as Study Coordinator or Study Nurse worked closely with CRAs; Lead CRA/management experience preferred but not required.
- Experience ensuring GCP compliance and successful risk management of complex clinical studies.
- Experience in all study phases and in multiple indications
- Experience conducting GCP or other training
- Experience communicating with site staff including KOLs.
- Experience with oversight and regulatory inspection.
- Site management and monitoring experience across a range of complex disease areas.
- Demonstrated capability of site oversight.
- Solid knowledge of clinical development processes with emphasis on site management.
- Comprehensive and current regulatory knowledge, including GCPs.
- Frequent travel in assigned region (required travel may be as high as 50% during busy period).
- 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
- Location(s): Cambridge, MA or remote.
- This posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. � 8-5-101 et seq.
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- Massachusetts - VirtualWorker Type
- Full time #LI-Remote
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