Study Site Engagement Lead
Company: Takeda Pharmaceutical
Posted on: May 13, 2022
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in my employment application is true 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 Study Site Engagement Lead in our Cambridge, MA or
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, encourage innovation, 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:
- Study Site Engagement Lead (SSEL) is the regional face of
Takeda for site relations and monitor engagement, supporting study
teams with startup and recruitment and ensuring qualified CRO-CRAs
are assigned to monitor clinical trial sites. The SSEL provides
support across Takeda CDO therapeutic areas.
- The SSEL engages and provides additional value by advising and
educating study sites, while building 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
- The SSEL contributes to a partnership between Takeda study
teams, study sites and the CRO. The SSEL establishes communication
with regional/country Medical Affairs (MA) and provides updates on
- The SSEL supports Takeda study teams in their Sponsor Oversight
responsibilities. through engaging with the Clinical Research
Organization - Clinical Research Associate (CRO-CRA) on-site during
routine monitoring visits.
- The purpose of this Monitoring Oversight Visit (MOV) is to
ensure that CRO-CRA can perform clinical monitoring
responsibilities according to the study protocol and
- Provide input to the study site list for feasibility and site
- May be consulted for country selection and may provide input to
country specific feasibility questions.
- Inform and partner with regional/country MA staff for site
identification and feasibility support with study team.
- Attend qualification visits (PSVs) as requested or agreed
- Provide regional/country MA with information on country and
- Attend and support site initiation visits (SIVs) and oversee
CRA during SIVs where needed.
- Reduce identified start up and enrollment barriers.
- As invited, attends investigator meetings (in the region) and
partner with sites / CRO.
- Implement recruitment support when targets are not met (e.g.
booster visits, phone calls).
- Work with study team throughout the lifecycle of the
- 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
- 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
- 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.Monitoring
Oversight Visit oversite:
- Review site monitoring visit reports and in-house essential
- Perform a pre-MOV assessment during a pre-MOV interview with
- Assess whether the CRO-CRA performs monitoring activities
according to the study protocol and ICH-GCP
- Escalate issues/queries to the COPL/APL and Clinical Quality
- Create MOV report / summary and shares with CRO Partner and
Takeda study team
- Recommend and agree next steps with COPL/APL and CQA following
- Work with service provider to schedule the co-monitoring visit.
Provide relevant information and documentation to service provider
to prepare for the co-monitoring visit.
- Schedule follow-up meeting with service provider and Takeda
study team after the co-monitoring visit.
- Review co-monitoring visit report and share with Takeda study
- Hands over open action items to Takeda study team and CRO
partner.EDUCATION AND EXPERIENCE:Education
- Scientific degree (MD, PhD, MA/MS, BA/BS) in pharmaceutical
science, chemistry, biology, medical/healthcare or comparable
- 8 or more years of relevant job experience in related roles in
pharmaceutical industry in R&D, Clinical Operations or Medical
- Have adequate clinical trial monitoring experience with a
knowledge of FDA or other local regulations and ICH GCP
- Have knowledge of Clinical trial processes.
- Knowledge of regional and country clinical trial
- Advanced knowledge of ICH-GCP.
- Healthcare industry knowledge.
- Common computer programs and databases.TRAVEL REQUIREMENTS:
- Travel up to 60%. Domestic and international travel is expected
for this position following regional assignments and location of
meetings, congresses and training.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 or remote.
- Base Salary Range: $155K-$165K 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
Keywords: Takeda Pharmaceutical, Newark , Study Site Engagement Lead, Other , Newark, New Jersey
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