Senior Manager, Study Site Engagement

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 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:

• Be 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)). Establish communication with regional/country Associate Director, Study Site Engagement, and Medical Affairs (MA), provides updates on study/site status, and establishes site engagement study specific strategies.
• Support study teams with trial operations from Feasibility through Clinical Study Report (CSR) within the assigned region or countries across Takeda therapeutic areas.
• 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. Supports country and site identification, feasibility, site selection, study start-up, study recruitment strategies, and mitigates barriers at the direction of Clinical Programs. 
• Support 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.
• Attend 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).
• Interact closely with local CRO team throughout the lifecycle of the study.
• Helps coordinate and/or attend 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 training (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

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

Development of Strategic Site Relationships

• 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

• 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, utilize 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.

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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, 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/Prior Oncology Clinical Trial Experience Required.
• 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 preferred.
• Comprehensive and current regulatory knowledge, including GCPs.
• Demonstrates flexibility in schedule and willingness to travel frequently in assigned region (required travel may be as high as 50% during busy period.