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Senior Manager, Study Site Engagement

Remote
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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 R0136091 Date posted 10/28/2024 Location Remote

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Job Description

Are you looking for a patient-focused company to inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as the Senior Manager, Study Site Engagement reporting to the Associate Director, Study Site Engagement based in Brazil.

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 work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers and work towards for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

GOALS:

  • The Senior Manager, Study Site Engagement is the local face of Takeda by contributing to an effective partnership between Takeda study teams, study sites and the Clinical Research Organization (CRO) (i.e., the Clinical Research Associate (CRA)). The Senior Manager, Study Site Engagement establishes communication with regional/country Associate Director, Study Site Engagement, and the Medical Affairs (MA), provides updates on study/site status, and establishes site engagement study specific strategies.
  • The Senior Manager, Study Site Engagement supports study teams with trial operations from Feasibility through Clinical Study Report (CSR) within the assigned region or countries across Takeda therapeutic areas.
  • The Senior Manager, Study Site Engagement enhances engagement and offers added value by providing guidance and sharing knowledge with study sites, while establishing and nurturing long-term relationships with investigators and study site personnel. The Sr. Manager, Study Site Engagement supports country and site identification, feasibility, site selection, study start-up, study recruitment strategies, and mitigates barriers at the direction of Clinical Programs. 
  • The Senior Manager, Study Site Engagement supports Takeda study teams as part of their day-to-day responsibilities and may act as a SSE-Study Lead (SSE-SL).

ACCOUNTABILITIES:

Study Specific Engagement Activities:

Early engagement - Country and site feasibility

  • Supports the Study Site Engagement Lead (SSEL)/ SSE Program Lead (SSE-PL)/SSE Study Lead (SSE-SL) 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 feasibility progress to SSE-PL/SSE-SL
  • Liaises with SSE-PL/SSE-SL, MA, local Clinical Operations team (if available) and CRO staff for site identification and feasibility support in alignment with global study team.
  • Attends Pre-Study Visit (PSV) as requested or agreed upon with the SSE-SL.
  • Helps to follow up with country MA, local Clinical Operations team and keep track country and site selection activities.

Study startup phase - Post site selection to site initiation

  • Supports the SSE-PL/SSE-SL in tracking start-up hurdles escalated to the team and their resolution to ensure Site Initiation Visits (SIVs) and site activations are achieved as planned.
  • Attends and/or supports SIVs.
  • Helps SSE-PL/SSE-SL 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 contacts).
  • 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/SSE-SL.
  • Regularly interacts with priority sites in assigned trials.
  • Helps to maintain study specific trackers (booster visits) as needed or requested.

Training

  • Applicable local regulations.
  • SOP trainings (Takeda and CRO, as applicable).
  • TA/Study specific training.

Non-Study Specific Engagement Activities (participation in following activities may vary depending on assignment by line manager):

SSE Study Lead for assigned programs

  • Helps to develop the global Site Engagement Strategy for the assigned trial, adapting it as necessary to meet specific requirements of each country.
  • Attends program and study level meetings, as applicable, and provides relevant updates to SSE team members.
  • Attends kick-off meetings, investigator meetings (in region).

Development of Strategic Site Relationships

  • The Senior Manager, Study Site Engagement, may be responsible for developing and maintaining long-term strategic relationships with selected sites/site networks to improve the site and Takeda experience.

Conferences, Congresses, Other Site Facing Events

  • The Senior Manager, Study Site Engagement may be tasked to help the Associate Director, Study Site Engagement with developing and executing the SSE strategy for non-study specific activities within their designated Therapeutic Area (TA) or Country.
  • Through participation in conferences or congresses, the Sr. Manager, Study Site Engagement utilizes these key site-facing events to connect with sites beyond their physical locations. This role involves engaging with new clinical trial investigators or those unfamiliar with Takeda, thereby promoting support for the advancement of our pipeline.

EDUCATION & 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, PharmD) is preferred.

  • 7+ years of experience in clinical research, either with a CRO or a pharmaceutical company, focusing on clinical trials. Experience may also include roles such as Study Coordinator or Study Nurse, where close collaboration with Clinical Research Associates was involved. While experience in a Lead CRA or managerial role is preferred, it is not mandatory. The total cumulative work experience of the candidate may also be taken into consideration.

  • 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.
  • Proven experience in effectively communicating with site staff including KOLs.
  • Experience in all study phases and in multiple indications preferred.
  • Good organizational skills and ability to deal with competing priorities.

  • Effective communication skills (written, verbal 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.

  • Comprehensive and current regulatory knowledge, including GCPs.

.

Locations

BRA - Brazil Remote

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

#LI-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

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

Penny Carlson - Head, Global Clinical Development Operations

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 17 companies to receive Top Global Employer® status for 2024.
  • 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

Patient


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

People


Create an exceptional people experience.

Planet


Protect our planet.

Data & Digital


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

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