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:
* Define and implement strategies for engaging clinical sites and investigators.
* Characterize and understand the attributes of good clinical sites versus poor performing sites.
* Engage clinical sites to develop, build, and maintain relationships with investigators and staff to ensure continued performance and capitalize on site expertise.
* Evaluate, screen, and develop high-quality investigative sites to support the company's clinical development programs.
* Ensure collaboration with key internal and external stakeholders, as well as third-party vendors.
* Develop, communicate, and execute the Site Engagement Strategy/Plan in collaboration with the clinical team and stakeholders throughout the trial lifecycle.
* Support clinical team in coordinating site engagement activities, understanding the competitive landscape, and addressing trial hurdles using motivational tactics.
* Engage, evaluate, and develop a global network of high-performing sites through coordinated interactions to increase awareness and partnership interest.
* Maintain relationships with site engagement organizations and identify high-performing sites and key opinion leaders for contributions to forums and discussions.
* Act as a point of escalation for site issues, providing communication channels to the clinical team and stakeholders.
* Assist sites with enrollment barriers by reinforcing recruitment plans.
* Support regional and cultural aspects of studies and assist with quality-related visits.
* Collaborate with partners to align systems and processes for site engagement.
* Ensure communication with stakeholders regarding site visits and activities.
* Train new investigators for clinical trials.
* Participate in therapeutic and industry training sessions.
* Serve as an internal advisor on site engagement, site selection, and patient recruitment.
* Facilitate communication and information exchange among stakeholders.
* 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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