Posted to MedZilla on 4/28/2017


The Medical Affairs Company

US-CA, Clinical Trial Liaison - Ophthalmology (West) 1612-MZ


 
 

Overview:

CTL position based in West (LA/San Fran) near major airport hub.

 

Serving as a value-added resource and extension of Medical Affairs, the Clinical Trial Liaison (CTL) will support the Company’s Clinical Development program in Retinal Vein Occlusion and potentially other ocular indications in the United States and Canada. The CTL will work full time to train clinical research sites in the suprachoroidal injection technique. The CTL will serve as a liaison between Company, the clinical study sites, and the contract research organization (CRO). 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’s interests.

 

As the initial focus for this team will be training the clinical sites, and end user, in delivering suprachoroidal injections, this individual must be comfortable with learning how to perform these ocular injections in animal models during the training period. The ideal candidate for this position possess a combination of Ophthalmology/Optometry clinical experience and clinical research experience within the academic, healthcare system or industry setting. 

 

This position will include compliance, regulatory, study specific and technique training. Company will be responsible for the delegation of investigators/study sites to the Clinical Trial Liaison based on geographic proximity, demand, availability, deadlines, priorities and other factors.

Accountabilities:

  • 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.
  • Perform suprachoroidal injection technique training to all clinical sites and/or investigator meetings as required.
  • 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 for the Contract Research Organization such as the site’s assigned study team members including field monitors.
  • Communicate any adverse event information, reports of concern or product complaints in accordance with Company’s policies.
  • Communicate on a regular basis with Company’s Clinical Development Department on study site status and PI relationships.
  • 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’s compounds can be appreciated by the healthcare practitioner, Thought Leader or investigator.
  • As assigned, attend regional and national medical conferences, to obtain new competitive information, stay informed of clinical trends and support, and maintain relationships with key investigators
  • Document all interactions and submit executed documents promptly.

Qualifications:

  • Candidates are required to be comfortable with learning how to perform ocular injections in animal models.
  • Relevant clinical trial experience and a healthcare background required
  • Medical or Allied Health degree/certification required
  • Experience in ophthalmology highly preferred
  • Ideal candidates will have 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 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 and possibly internationally is required; overnight travel is required as needed (60-70%).
  • Demonstrated project management ability.
  • Computer skills including Excel, Word, Power Point, Outlook and programs such as LiveMeeting® are expected.
  • Valid driver’s license and US Passport.


Please visit our website at themedicalaffairscompany.com

 
 


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