TMAC Outsourced Opportunity.

Territory coverage: NY, NJ, MA, CT, VT, NH

Serving as a value-added resource and extension of Medical Affairs the Clinical Trial Liaison (CTL) will support the Company’s Neurology Clinical Development program in the United States. The CTL will work full time to educate, analyze, and resolve issues with clinical research sites and investigators. The CTL will serve as a liaison between Company, the clinical study sites and the clinical research associates (CRAs). The CTL 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.

This position will include compliance, regulatory and study specific training.Documentation of all interactions, process, 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:

• 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 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 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.
• 2+ years of clinical research experience within academic, healthcare system or industry setting (e.g., clinical research coordinator, research manager, clinical research associate, study coordinator, research director). Qualified individuals will have a strong familiarity of and experience with clinical research and study site logistics.
• Prior Pharmaceutical or Device industry experience as a Medical Liaison or Clinical Trial Liaison highly regarded. Candidates should have a solid understanding of scientific exchange in the context of a compliance landscape.
• 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
• Excellent oral and written communication skills and interpersonal skills
• Exceptional organizational and time management skills are essential
• Knowledge of FDA compliance and regulatory requirements
• Ability to integrate and work in cross functional network
• 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