TMAC (The Medical Affairs Company (TMAC)) - null, Spain
The Site Engagement Manager (SEM) is responsible for providing operational expertise to sites through ownership and management of the Site Engagement Strategy. The scope includes :
Duties and Responsibilities :
* Define and implement strategies for engaging clinical sites and investigators.
* Characterize and understand attributes of good versus poor performing clinical sites.
* Engage with clinical sites to develop and maintain relationships with investigators and staff, ensuring ongoing performance and leveraging site expertise.
* Evaluate, screen, and develop high-quality investigative sites to support clinical development programs.
* Collaborate with internal and external stakeholders, including third-party vendors.
* Develop, communicate, and execute the Site Engagement Strategy / Plan in coordination with the Clinical Team and stakeholders throughout clinical trial cycles.
* Support clinical team in coordinating site engagement activities, understanding the competitive landscape, overcoming trial hurdles, and motivating sites for timely trial delivery.
* Build and maintain a global network of high-performing sites through coordinated interactions across communication channels, raising awareness of the Company's activities.
* Maintain relationships with site engagement organizations and identify key opinion leaders for contributions to company forums and discussions.
* Serve as an escalation point for site issues, facilitating communication between sites and the clinical team, stakeholders, and vendors.
* Assist with site enrollment barriers by reinforcing recruitment plans.
* Support studies from regional and cultural perspectives and assist with quality visits.
* Align with partners on systems and processes for site identification and engagement.
* Ensure communication with stakeholders regarding site visits and activities.
* Train and interact with new investigators for clinical trials.
* Participate in therapeutic and industry training sessions.
* Act as an internal advisor on site engagement, site selection, and patient recruitment.
* Travel up to 50%, including overnight stays, possibly globally.
Qualifications :
* Terminal scientific degree (e.g., PhD, MD, DO, PharmD, PsyD, DNP) preferred; Master's or Bachelor's considered based on experience.
* Minimum 5 years' experience in Pharma, biotech, or CRO, especially in site engagement or investigator-facing roles.
* Strong familiarity with clinical research and site logistics.
* Experience in immunology or autoimmune diseases preferred.
* Experience as a Clinical Trial Liaison or similar role is highly regarded.
* Understanding of scientific exchange within a compliance framework.
* Fluency in English and the local language of residence.
* Proactive in engaging and motivating investigators and sites.
* Effective communicator with strong presentation skills.
* Knowledge of FDA regulations, GCP, and compliance standards.
* Ability to work independently in a dynamic environment.
* Skilled in conflict management and consensus building.
* Capable of managing a geographically dispersed territory from a home office.
* Willing to travel extensively, including overnight stays.
* Proficient in MS Office and virtual communication tools (LiveMeeting, Zoom, MS Teams).
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