Clinical Trial Liaison

hace 7 días

Madrid, Madrid, España Syneos Health Clinical A tiempo completo

Overview
The Clinical Trial Liaison is responsible for providing non-promotional scientific, educational, and research support for

client's clinical studies. The CTL should be highly trained in assigned therapeutics area and well-versed in clinical research

and practice. A primary focus of this role and basis for measuring CTL performance is the ability to identify appropriate

patients with Agitation in Alzheimer's Disease (AAD) and their treating physicians, support acceleration of clinical studies

completion through identification of new clinical sites, collaboration with existing sites, and/or enrollment of appropriate

patients in client-sponsored clinical trial.

The CTL will work with the clinical investigators and site staff to support patient enrollment and retention initiatives, identify,
mitigate and provide solutions to enrollment hurdles, disseminate product/trial information and training to sites as needed,
by providing the clinical study team with insights and information regarding site-specific feedback or recruiting best
practices, and representing company interests through appropriate consistent responses to study specific questions or
more detailed discussions or resolution as directed).

investigators and research staff to ensure full engagement throughout the course of the study. The focus will be to enhance
clinical trial execution and enrollment through building deep relationships with study investigators and research staff.

Responsibilities

Summary of Responsibilities - Feasibility Support

  • Establishes and maintains strong working relationships with Principal Investigators (PIs) and clinical trial sites to support the enrollment and conduct of clinical studies
  • Identifies physicians currently managing patients with Agitation in Alzheimer's Disease (AAD) and cultivates a network of experts in treatment of AAD at academic and community centers to identify new trial sites and/or drive patient referrals and rapid enrolment
  • Delivers medical / scientific training to clinical study sites and provides input to key internal stakeholders on training materials for clinical trials, products in development, therapeutic areas, and disease state as outlined by the sponsor

Post Site Activation/Patient Recruitment Support

  • Provides field insight to the study teams related to trends for the identification and recruitment of the patients
  • Prepares and gives internal presentations on the status of enrollment and recruitment activities
  • Follows up with site post initiation to ensure patient enrolment is run smoothly, identifies challenges, issues and barriers and reports back to SH & Avanir and works with study teams and sites to develop solutions
  • Gathers and shares 'Best Practices' and tactics for rapid patient enrolment among trial sites
  • May participate in site visits with investigators, site staff and CRAs in support of clinical trial execution

Other Duties

  • As requested by sponsor, attends key medical, science and advocacy meetings to identify potential investigators and/or referring physicians
  • Develops a network and heat maps of HCPs/hospitals involved in study specific diagnosis and management of patients
  • Participates in the review of study related documents and plans, as applicable (i.e. recruitment plans)
  • Communicates investigator/study coordinator inquiries requiring followup to designated contacts and collaborates with clinical teams prior to providing approved responses to site inquiries appropriately to ensure focused and balanced clinical and scientific information
  • Adhere to regulatory and compliance guidelines and company policies.
  • Address administrative and reporting needs on a timely basis or as requested by management, including documenting of CTL activities into Customer Relationship Management (CRM) as required

Job Requirements

  • Advanced degree in clinical specialty (PharmD, PhD, MD) with clinical experience
  • 5+ years experience as an MSL/CTL or senior clinical development role
  • 3+ years CNS (ideally Alzheimer) experience required
  • 3+ years of experience in pharmaceutical industry with knowledge of clinical research design and conduct.
  • Existing solid relationships in AAD diagnostic and treatment centers with proven ability to develop relationships with referral physicians
  • Experience in clinical research, patient recruitment, and investigator sponsored trials
  • Strong oral and written communication skills, skilled at presenting scientific content
  • Selfstarter, highly accountable, and skilled problem solver
  • Very good understanding of networking and patient enrolment strategies
  • Passionate about making a meaningful difference for patients
  • Ability to manage a geographically assigned territory from a homebased office. Will be responsible for large geography, requiring 7580% travel
  • Should be fluent in 2 or more languages, including English
  • ICH/GCP guidelines and all applicable regulatory requirements
Inter

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