at Takeda Pharmaceuticals in Springfield, Illinois, United States
Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Study Site Engagement Lead in our Cambridge, MA office or based remote 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.
+ Study Site Engagement Lead (SSEL) is the regional face of Takeda for site relations and monitor engagement, supporting study teams with feasibility, startup, and recruitment across Takeda therapeutic areas.
+ The SSEL will advise and educate study sites, while building and maintaining sustainable relationships with investigators and study site personnel. The SSEL supports country and site identification, feasibility, site selection, study recruitment strategies, and mitigates barriers at the direction of Clinical Programs.
+ The SSEL contributes to the partnership between Takeda study teams, study sites and the CRO. The SSEL establishes communication with regional/country Medical Affairs (MA) and provides updates on study/site status.
+ The SSEL supports Takeda study teams in their Sponsor Oversight responsibilities trough feedback from attending site qualification, initiation and booster (performed together with the CRO CRA) visits.
Study start-up phase – Country and site feasibility
+ Provide input to the study site list for feasibility and site selection.
+ May be consulted for country selection and may provide input to country specific feasibility questions.
+ Inform and communicate with regional/country MA staff for site identification and feasibility support with study team.
+ Attend qualification visits (PSVs) as requested or agreed upon.
+ Provide regional/country MA with information on country and site selection.
Study startup phase – Post site selection to site initiation
+ Attend and support site initiation visits (SIVs) and oversee CRA during SIVs where needed.
+ Reduce identified start up and enrollment barriers.
+ As invited, attend investigator meetings (in the region), and communicate with sites / CRO.
Enrollment and study conduct phase.
+ Implement recruitment support when targets are not met (e.g., booster visits, phone calls).
+ Work with study team throughout the lifecycle of the study.
+ Provide written feedback to the Associate Program Lead (APL)/Clinical Operations Program Lead (COPL) after every site visit and escalates any site or CRA concerns.
+ Facilitate regional/country MA engagement where needed, with study team.
Participation in following activities may vary depending on assignment by Line Manager:
+ Establish communication with regional/country Medical Affairs (MA) and provide updates on planned and ongoing global clinical studies, with a focus on upcoming feasibilities, study status and enrollment updates, specific site issues and HCPs contacted in the region/country.
+ Distribute quarterly reports generated by GCDO to the Local Operating Companies (LOCs) in the assigned region.
+ Attend study meetings, as applicable, and provide relevant updates to SSEL team members.
+ Attend kick-off meetings, investigator meetings (in region)
EDUCATION AND EXPERIENCE:
+ Bachelor’s degree or international equivalent is required in pharmaceutical science, chemistry, biology, medical/healthcare or comparable background. Advanced degree preferred.
+ 8+ years of experience in related roles in pharmaceutical industry in R&D, Clinical Operations or Medical Affairs.
+ Can work and communicate in a global setting.
+ Must have clinical research experience with knowledge of FDA or other local regulations and ICH GCP Guidelines.
+ Must have knowledge of clinical trial processes.
+ Knowledge base of outsourcing and CRO partnership/management
+ Frequent travel in assigned region (required travel may be as high as 50% during busy period).
WHAT TAKEDA CAN OFFER YOU:
+ Base Salary Range: $143,500 to $205,000. 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.
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.
USA – MA – Virtual