Serving as a value-added resource and extension of Medical Affairs the Clinical Trial Liaison Team Lead (CTL) will support the Company’s Neurology Clinical Development program in the United States. The CTL Team Lead will work full time to educate, analyze, and resolve issues with clinical research sites and investigators. The CTL Team Lead will serve as a liaison between Company, the clinical study sites and the clinical research associates (CRAs). The CTL Team Lead will be responsible for identifying and conducting outreach to clinical investigators and site staff to develop relationships, support education, and enrollment initiatives and represent Company interests.

The CTL Team Lead is responsible for mentoring and coaching the CTL team and assisting in the development and oversight of CTL field activities.  The Team Lead is also responsible for ensuring the CTL team attains their stated goals and objectives and providing activity updates to the management team as requested.

This position will include compliance, regulatory and study-specific training. Documentation of all interactions, processes, metrics, and reporting will be directed and executed in accordance with Company policy. The delegation of investigators/study sites to the Clinical Trial Liaison based on geographic proximity, demand, availability, deadlines, priorities, and other factors.

Duties and Responsibilities:

• Assist CTLs in development of business plans and ensure execution and alignment with client’s priorities
• Execute regular teleconference consultations with CTLs to coach, mentor, and ensure compliance
• Assess and identify training gaps for individual CTLs and for CTL team
• Execute training activities as directed including but not limited to new hire orientation, activity tracking system, scientific/therapeutic subject matter, and compliance policies.
• Participate in evaluation and development of professional competencies and skills of CTLs
• Ensure CTL performance and compliance through regular review of activity reports.
• Assist in development and refinement of activity reports
• Provide routine updates and reports to Senior Director, Field Medical (TMAC) and Company management.
• Complete internal education/training on all assigned SOPs, study protocols, and relevant products. Comply with all applicable laws, regulations, policies, procedures, and training relevant to the position.
• Identify and conduct outreach to clinical investigators, site staff and referring physicians to develop relationships, support enrollment initiatives and represent the Company’s interests.
• Prepare for and present study information via formal presentations to investigators, site staff and referring physicians to generate interest for participation in company-sponsored studies or related activities and/or to confirm understanding of a specific protocol.
• Engage site staff and investigators in discussion to understand and report challenges in subject enrollment and retention and offer potential solutions.
• Upon request, educate clinical trial sites and referring physicians about clinical trial protocol, disease state or study design.
• Interact and build positive relationships with key stakeholders on the Clinical Research team such as the site’s assigned study team members including field monitors and CRAs.
• Communicate any adverse event information, reports of concern or product complaints in accordance with the Company’s policies.
• It is expected, that the CTL be solidly versed in the clinical data such that the full range of innovative science and clinical aspects of Company compounds can be appreciated by the healthcare practitioner, Thought Leader or investigator.
• As assigned, attend local, regional and national medical conferences, to obtain new competitive information, stay informed of clinical trends and support and maintain relationships with key investigators
• Communicate investigator/study coordinator inquiries requiring follow-up to designated contacts within Company and/or the Clinical Research team.
• Document all interactions and submit executed documents promptly.

Qualifications:

• Significant relevant clinical trial experience and a healthcare/science background inclusive of PharmD, PhD, and MD (or equivalent) required.
• 5 + years prior Pharmaceutical experience as a Medical Liaison or Clinical Trial Liaison required. Candidates should have a solid understanding of scientific exchange in the context of a compliance landscape.
• Neurology experience
• Established track record of effective and influential oral presentations within the healthcare profession
• Experience presenting to both large and small audiences is required for success in this position
• Knowledge of FDA compliance and regulatory requirements
• Ability to manage a geographically assigned territory from a home-based office
• Willingness to travel within the assigned region is required; overnight travel is required as needed (estimated at 5-10 per month)
• Valid driver’s license