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Job Description

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 remote reporting to the Study Site Engagement 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:

• Senior Study Site Engagement Manager (Sr. SSEM) is the regional representative of Takeda for site relations and Clinical Research Associate (CRA) engagement, will support study teams with startup and recruitment, and fulfill sponsor oversight activities. You will coordinate operational aspects of Takeda Sponsored studies from Feasibility through CSR within the assigned region or countries across Takeda therapeutic areas.
• The Sr. SSEM will advise and educate study sites while building and maintaining sustainable relationships with investigators and study site personnel. You will support country and site identification, feasibility, site selection, study startup, study recruitment strategies, and reduce barriers at the direction of Clinical Programs.
• The Sr. SSEM will partner with field monitoring CRAs, local Clinical Research Organization (CRO) team, and global study team and support Takeda study teams in their Sponsor Oversight responsibilities.
• The Sr. SSEM will contribute to the partnership between Takeda study teams, study sites and the CRO. You will communicate with regional/country Medical Affairs (MA) and provide/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 and site selection.
• Help track feasibility progress and escalations for SSEL/LOC support.
• Report any discrepancy on CRO feasibility progress to SSEL/SSE PL
• Partner with regional/country SSEL, MA, local Clinical Operations team and CRO staff for site identification and feasibility support 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 site initiation visits (SIVs) and site activations are achieved as planned.
• Attend and support SIVs and oversee CRAs 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, attend Investigator Meetings (in the region) and partner 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 and attend the SSE booster visit requested by SSE PL.
• Work with priority sites in assigned trials.
• Help to maintain study specific trackers (booster visits).

EDUCATION AND EXPERIENCE:

• Bachelor's Degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences or drug development is required. A clinical or advanced degree (BSN, 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.
• Demonstrated site management experience across a range of complex disease areas.
• Knowledge of clinical development processes with emphasis on site management.
• Experience ensuring GCP compliance and successful risk management of complex clinical studies.
• Experience communicating with site staff including KOLs and experts.
• Experience in all study phases and in multiple indications.
• Comprehensive and current regulatory knowledge, including GCPs.
• Previous oversight and regulatory inspection experience preferred.
• Experience conducting GCP or other training preferred.

TRAVEL REQUIREMENTS:

• Frequent travel in assigned region (required travel may be as high as 50% during busy period).

WHAT TAKEDA CAN OFFER YOU:

• Base Salary Range: $130,200 - $186,000. Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.
• The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

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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EEO Statement

Takeda 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.

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