Job Description

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Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Senior Manager, Study Site Engagement based remotely in Canada 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.

GOALS:

• Senior Study Site Engagement Manager (Sr. SSEM) is the regional representative of Takeda for site relations and Clinical Research Associate (CRA) engagement, will support study teams with startup and recruitment, and fulfill sponsor oversight activities. You will coordinate operational aspects of Takeda Sponsored studies from Feasibility through CSR within the assigned region or countries across Takeda therapeutic areas.
• The Sr. SSEM will advise and educate study sites while building and maintaining sustainable relationships with investigators and study site personnel. You will support country and site identification, feasibility, site selection, study startup, study recruitment strategies, and reduce barriers at the direction of Clinical Programs.
• The Sr. SSEM will partner with field monitoring CRAs, local Clinical Research Organization (CRO) team, and global study team and support Takeda study teams in their Sponsor Oversight responsibilities.
• The Sr. SSEM will contribute to the partnership between Takeda study teams, study sites and the CRO. You will communicate with regional/country Medical Affairs (MA) and provide/collect updates on site status.

ACCOUNTABILITIES:

Early engagement - Country and Site Feasibility

• Support 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
• Help track feasibility progress and escalations for SSEL/LOC support.
• Report any discrepancy on feasibility progress to SSE-PL/SSE-SL.
• Partner with SSE-PL/SSE-SL, MA, local Clinical Operations team and CRO staff for site identification and feasibility support 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 on country and site selection activities.

Study Startup Phase - Post Site Selection to Site Initiation

• Support the SSE-PL/SSE-SL in tracking startup hurdles escalated to the team and their resolution to ensure SIVs and site activations are achieved as planned.
• Attend and supports site initiation visits (SIVs).
• Help 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, attend Investigator Meetings (in the region) and liaises with sites/CRO.

Enrollment and Study Conduct Phase

• Support recruitment strategy and activities when targets are not met (e.g. utilization of PR&R materials, booster visits, phone calls).
• Work with local CRO team throughout the lifecycle of the study.
• Help coordinate and attend the SSE booster visit requested by SSE-PL/SSE-SL.
• Work with priority sites in assigned trials.
• Help to maintain study specific trackers (booster visits).

Training:

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

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 Senior Manager, Study Site Engagement regularly interacts with internal and external stakeholders. Key stakeholders for this role include Takeda Clinical Operations, Takeda Clinical Study Start-up and Engagement (CSSE) functions, Takeda Clinical Science, Takeda Medical Affairs, local R&D functions, site and CRO personnel.

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 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.
• Comprehensive and current regulatory knowledge, including GCPs.

Locations

CAN - Remote (Quebec)

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Takeda