Bank CV's - Incyte - Clinical Data Coordinator

The Clinical Operations Lead supports the Clinical Trial Manager/operational team in execution of the trial (s). The
position includes direct liaison with CROs and other ancillary vendors, as appropriate, to manage relevant trial(s)
operational tasks. The Lead maintains effective communication with project team through oral and written
correspondence, status reports to ensure alignment with study timelines.

• Assist in the review, development and writing of clinical trial documents and manuals, including but not
  limited to study manuals, laboratory or biomarker plans, and other supporting documents.
• Create Master ICF template and review/approve site changes (in consultation with legal, safety when
  warranted). Update template for new risks and new amendments information.
• Participate in the feasibility and evaluation of investigative sites; working closing with the Clinical Trial
  Logistics group.
• Coordinate and monitor activities at investigational sites; review monitoring trip reports and support the US
  monitoring organization.
• Assist in the development and management of study timelines and priorities, including recruitment
  tools/strategy and patient retentions plan.
• Plan and organized meetings with team support (eg. investigator/coordinator meetings, DMC, SMC, safety
  call, etc.).
• Assist in the development of the IP and co-medication strategy (Quantities, labels, depots, tracking, etc.)
  working closely with other departments.
• Participate in data review and discrepancy resolution.
• Participate in coordinating efforts with internal Pharmacovigilance, and safety group.
• Monitor study-specific timelines and key deliverables; focus on management of all external vendors (e.g
  Monitoring, Sample management, IVRS, Laboratory, etc).
• Participate as a member of the multi-disciplinary trial(s) team.
• Develop relationships with investigational sites and institutions to enhance conduct of the trial.
  Acts as preliminary liaison for study sites to convey trial information, answer questions and in accordance
  with the escalation pathway.
• Assume responsibility to participate as a member of a working group and perform special projects, as
  assigned, to improve the efficiency, effective and quality of the functioning of the Development Operations
  Department.

• BS/BA degree or a relevant degree with strong emphasis on science.
• Minimum of three years of experience in the biopharmaceutical industry or other relevant clinical research
  experience.
• Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority
  experience.
• Ability to effectively manage multiple priorities across several protocols and therapeutic areas
  simultaneously.
• Prior experience in assisting the conduct and management of multinational clinical trials is preferred.

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