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 of this role includes:
Duties and Responsibilities:
1. Define and implement strategies for engaging clinical sites and investigators.
2. Characterize and understand the attributes of good clinical sites versus poor performing sites.
3. Engage clinical sites to develop, build, and maintain relationships with investigators and staff to ensure continued performance and capitalize on site expertise.
4. Evaluate, screen, and develop high-quality investigative sites to support the company's clinical development programs.
5. Ensure collaboration with key internal and external stakeholders, as well as third-party vendors.
6. Develop, communicate, and execute the Site Engagement Strategy/Plan in collaboration with the clinical team and stakeholders throughout the trial lifecycle.
7. Support clinical team in coordinating site engagement activities, understanding the competitive landscape, and addressing trial hurdles using motivational tactics.
8. Engage, evaluate, and develop a global network of high-performing sites through coordinated interactions to increase awareness and partnership interest.
9. Maintain relationships with site engagement organizations and identify high-performing sites and key opinion leaders for contributions to forums and discussions.
10. Act as a point of escalation for site issues, providing communication channels to the clinical team and stakeholders.
11. Assist sites with enrollment barriers by reinforcing recruitment plans.
12. Support regional and cultural aspects of studies and assist with quality-related visits.
13. Collaborate with partners to align systems and processes for site engagement.
14. Ensure communication with stakeholders regarding site visits and activities.
15. Train new investigators for clinical trials.
16. Participate in therapeutic and industry training sessions.
17. Serve as an internal advisor on site engagement, site selection, and patient recruitment.
18. Facilitate communication and information exchange among stakeholders.
19. Travel up to 50%, including overnight stays, possibly globally.
Qualifications:
* Terminal scientific degree (e.g., PhD, MD, DO, PharmD, PsyD, DNP, or equivalent), preferred.
* Master's and Bachelor's degrees considered based on experience and therapeutic expertise.
* Minimum of 5 years in pharmaceutical, biotech, or CRO industry, with experience in site engagement or investigator-facing roles.
* Strong familiarity with clinical research and site logistics.
* Preferred experience in Immunology or Autoimmune Diseases.
* Experience as a Clinical Trial Liaison or similar role is highly regarded.
* Understanding of scientific exchange within a compliance landscape.
* Fluency in English and local language.
* Proactive, motivated, and effective communicator with experience in scientific or healthcare presentations.
* Knowledge of FDA compliance, GCP, and regulatory requirements.
* Ability to operate in an international, dynamic environment and manage a regional territory remotely.
* Strong problem-solving, conflict management, and cross-functional collaboration skills.
* Proficient in MS Office and virtual communication tools (LiveMeeting, Zoom, MS Teams).
Posted: Monday, December 23, 2024
Job # 3546
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