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Sr. Study Site Engagement Manager

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  • Job Type: Full Time
  • Job Level: Senior
  • Travel: Minimal

At Takeda, we exist to create better health for people and a brighter future for the world. While we continually evolve science and technology, our ambition remains steadfast — we move science forward so we can transform more lives. The Global Development Office (GDO) maintains a laser focus on Study Management and Site Engagement, Clinical Trial Innovation, Clinical Supply Chain and Patient Safety to ensure absolute quality and enable the predictable delivery of our innovative pipeline.

Through its collaborative process, the GDO team leverages data, digital and analytics to improve speed, quality, performance and predictability within every area of clinical development. We’re building a platform to visualize operational data and enable predictive analytics, while leveraging digital technologies to support clinical supply chain and patient safety. GDO also partners with external organizations and leading academic institutions, such as MIT, to spark innovation in AI and Machine Learning focused on better patient outcomes.

At the heart of GDO are our people: we are committed to building a more diverse, equitable and inclusive culture not only within our own walls and our communities, but also across our clinical trials. It is our passion for people that transforms our work into meaningful action. Come join a team that has earned trust for more than two centuries and advances transformative therapies with honesty, integrity and fairness.

Job ID R0105446 Date posted 09/29/2023 Location Remote

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Job Description


  • Sr. Study Site Engagement Manager (SSEM) is the regional representative of Takeda for site relations and Clinical Research Associate (CRA) engagement, supporting study teams with timely start-up and recruitment, and helping to fulfill sponsor oversight activities. SSEM coordinates operational aspects of Takeda Sponsored studies from Feasibility through CSR within the assigned region or countries across Takeda therapeutic areas.
  • The SSEM engages and provides additional value by advising and educating study sites while building and maintaining sustainable relationships with investigators and study site personnel. The SSEM supports country and site identification, feasibility, site selection, study start-up, study recruitment strategies, and mitigates barriers at the direction of Clinical Programs. 
  • The SSEM interfaces with field monitoring CRAs, local Clinical Research Organization (CRO) team, and global study team and supports Takeda study teams in their Sponsor Oversight responsibilities.
  • The SSEM contributes to an effective partnership between Takeda study teams, study sites and the CRO. The SSEM contributes to the efficient communication with regional/country Medical Affairs (MA) and provides as well as collect updates on site status.


Early engagement - Country and site feasibility

  • Supports the Study Site Engagement Lead (SSEL)/ SSE Program Lead (SSE PL) with the development of study site list for feasibility - site selection and aids in tracking feasibility progress and escalations for SSEL/LOC support.
  • Reports any discrepancy on CRO feasibility progress to SSEL/SSE PL
  • Liaises with regional/country SSEL, MA, local Clinical Operations team and CRO staff for site identification and feasibility support in alignment with global study team.
  • Attends qualification visits (PSSVs (Pre Study Site Visits)) as requested or agreed upon with the SSEL.
  • Helps 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

  • Supports the SSEL/SSE PL  in tracking start-up hurdles escalated to the team and their resolution to ensure SIVs and site activations are achieved as planned.
  • Attends and/or supports site initiation visits (SIVs) and oversees CRA during SIVs agreed upon with the SSEL.
  • Helps SSEL/SSE PL in tracking resolution of any follow-up item needed post SIV until resolved by site and or CRO/Takeda study team.
  • As invited, attends Investigator Meetings (in the region) and liaises with sites / CRO.

Enrollment and study conduct phase

  • Supports recruitment strategy and activities when targets are not met (e.g. utilization of PR&R materials, booster visits, phone calls).
  • Interacts closely with local CRO team throughout the lifecycle of the study.
  • Helps coordinate and/or attends the SSE booster visit requested by  SSE PL.
  • Regularly interact with priority sites in assigned trials.
  • Helps to maintain study specific trackers (booster visits) as needed or requested.

Study specific training

  • Protocol, therapeutic area, investigational product, competitive landscape, processes & procedures – class room and self-training based on available training materials


  • Applicable local regulations
  • SOP trainings (Takeda and CRO, as applicable)

Help SSE team keep track of items the function will need to address on future interactions with the site.


The SSEM provides 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 in line with the level of service agreed. The SSEM engages and provides additional value by advising and educating study sites, building sustainable investigator and site relationships, and maintaining site communication as needed throughout the study.

Technical/Functional (Line) Expertise

Understanding of clinical trials and advanced knowledge of ICH-GCP, Clinical trials regulations, and applicable global and regional/country requirements. 

Decision-making and Autonomy

Able to make sound decisions after identification of an issue and being able to make careful consideration of various courses of action towards resolution. Considers the short and long-term impact of those decisions in terms of risk to Takeda from a regulatory, legal, financial and business acumen perspective. Influencing and motivational skills are needed for tactful and business smart communication with key internal- and external stakeholders.


The SSEM regularly interacts with internal and external stakeholders. Key stakeholders for this role are SSEL/SSE-PL, Takeda Clinical Operations, Takeda Clinical Study Start-up and Engagement (CSSE) functions, Takeda clinical scientist, investigators and study site personnel, CRO-CRAs and CRO-CPMs, CQA, Medical Affairs, local R&D functions and third-party vendors.


Working knowledge of research objectives, protocol design, clinical monitoring and data collection standards. Understanding of processes across Global Clinical Operations.


Possesses inter-cultural competences and ability to work cross-functionally in a complex global organization.


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, PharmD) is 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.

Essential qualifications:

  • Extensive site management and/or monitoring experience across a range of highly complex disease areas
  • Demonstrated capability of effective site oversight
  • Solid knowledge of clinical development processes with strong emphasis on site management
  • Ability to lead, troubleshoot and influence for quality and delivery
  • A track record of ensuring GCP compliance and successful risk management of complex clinical studies is expected
  • Proven experience in effectively communicating with site staff including and including KOLs and thought leaders
  • Experience in all study phases and in multiple indications (rare medical conditions preferred)
  • Previous oversight and regulatory inspection experience preferred
  • Comprehensive and current regulatory knowledge, including GCPs
  • Experience conducting GCP or other training is a plus

Good organizational skills and ability to deal with competing priorities Effective communication skills (written, verbal and presentation in English and local language).

Creative thinker, curious and unafraid to ask questions Innovator, willing to initiate changes, introduce new ideas, and creatively problem solve Proficient with MS Office Suite (Excel, Word and PowerPoint).

Demonstrates flexibility in schedule and willingness to travel frequently in assigned region (required travel may be as high as 50% during busy period ).


TUR - Turkey Remote

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Where you fit in

As a member of GDO, you will play an important role in bringing forward our rich pipeline of life-changing products to help patients. You will find enriching engagement and a mindset of continuous improvement through creativity, innovation and diversity.

We are a global organization present in the U.S., Europe and Asia with colleagues located in several additional countries to strategically support our business needs. But our people, and the culture they build, are the foundation that sets GDO apart. Our belief in putting people first extends beyond patients. It includes their families and communities, and also our Takeda colleagues and our families.

Working closely with GDO colleagues and key stakeholders across R&D, you will leverage our new operating model and innovative technologies to accelerate the development of our current and future portfolio to bring medicines to patients faster.

  • Advance clinical research

  • Deliver clinical analytics and study insights using innovative technologies to improve trial accessibility and patient centricity

  • Enable end-to-end management of clinical supply

  • Ensure safety management and inspection readiness

One of the main reasons I came to Takeda is because of the people I would be working for.We all use PTRB as our North Star. I think that makes it easier to delegate decisions and empower each level of the organization to contribute in a meaningful way.

Marisa Rackley - Head, Clinical Site Startup & Engagement, Global Development Office

It’s leveraging technology, it’s leveraging data in a very different way. It’s not just about using the data that we generate, but using real world data and having access to a much more holistic set of data in order to drive the way we work and deliver medicines to patients.

Penny Carlson - Head of Innovation and Data, Global Development Office

The culture at Takeda is very unique. It’s a culture that’s extremely collaborative in nature, requiring people from diverse backgrounds to come together, speak up, and really think about the most important thing we need to do for our patients.

Saurabh Awasthi - Executive Director, Trial Insights & Performance Optimization, Global Development Office

The heart of our work

Shining a light on new perspectives

Our pipeline

Our internal research capabilities and external partnerships contribute to an R&D engine that has produced exciting new molecular entities (NMEs) across our core Therapeutic Areas. Check out our pipeline and see how we’ll continue delivering a steady stream of next-generation therapies.

Learn more

What we believe in

Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

  • Integrity

  • Fairness

  • Honesty

  • Perseverance

Working at Takeda

  • Inclusion

    Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
  • Collaboration

    A strong, borderless team, we strive together towards our priorities and inspiring mission.
  • Innovation

    Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
  • Top Workplace

    Recognized for our culture and way of working, we’re one of only 15 companies to receive Top Global Employer® status for 2023.
  • Work-Life

    Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
  • Empowerment

    Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

We're Steadfast In Our Commitment to Four Key Imperatives


Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.


Create an exceptional people experience.


Protect our planet.

Data & Digital

Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.

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