Takeda Pharmaceutical Prague Czechia
2 weeks ago
• 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.
CORE ELEMENTS RELATED TO THIS ROLE:
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.
• 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 ).
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