Senior Study Site Engagement Manager
Company: Takeda Pharmaceutical
Posted on: November 22, 2022
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to the best of my knowledge.Job DescriptionAre 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.GOALS:
- 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
- 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
- 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.ACCOUNTABILITIES: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
- 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
- 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
- Work with local CRO team throughout the lifecycle of the
- Help coordinate the SSE booster visit requests received from
- Help to maintain study specific trackers (booster
visits).Sponsor Oversight Activities
- Contribute to the Sponsor Oversight activities:
- Review Site Monitoring Visit reports and in-house important
- 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.Site Engagement:
- 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
- Engage and provide additional value by advising and educating
study sites, building sustainable investigator and site
relationships, and maintaining site communication throughout the
- Support Takeda study teams in their Sponsor Oversight
responsibilities through reviewing monitoring reports and arranging
MOVs with the CRO-CRA during routine monitoring visits.EDUCATION
- Bachelor's Degree or international equivalent is required. A
clinical or advanced degree (RN, MS, MA, MBA, or PharmD),
- 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
- 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
- Frequent travel in assigned region (required travel may be as
high as 50% during busy period).WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution
- Tuition reimbursement Company match of charitable
- Health & Wellness programs including onsite flu shots and
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach ProgramsLocation and Salary Information:
- Location(s): Cambridge, MA or remote.
- Base Salary Range: $155K-$175K based on candidate professional
experience level.This posting is made in compliance with Colorado's
Equal Pay for Equal Work Act, C.R.S. - 8-5-101 et seq.Empower Our
People to ShineDiscover more at takedajobs.comNo Phone Calls or
Recruiters Please.EEO StatementTakeda is proud in its commitment to
creating a diverse workforce and providing equal employment
opportunities to all employees and applicants for employment
without regard to race, color, religion, sex, sexual orientation,
gender identity, gender expression, parental status, national
origin, age, disability, citizenship status, genetic information or
characteristics, marital status, status as a Vietnam era veteran,
special disabled veteran, or other protected veteran in accordance
with applicable federal, state and local laws, and any other
characteristic protected by law.LocationsMassachusetts -
VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Hamilton , Senior Study Site Engagement Manager, Professions , Hamilton, Ohio
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