Associate Director, Clinical Project Manager

Responsibilities

  • Responsible for the overall operational setup and execution of clinical studies related to our dermatology/pruritus program; from study concept through study completion
  • Manage day-to-day activities associated with the conduct of clinical Phase 2 and Phase 3 clinical studies from implementation to study closure
  • Lead internal project team meetings and participate and present in investigator or project team trainings as required
  • Develop/review clinical trial budgets and ensure execution of deliverables within approved budget and timelines
  • Identify prospective investigative sites and participate in final investigative site selection or liaise with vendors to ensure quality site selection
  • Aware of both internal and external business environments with the ability to assess impact on clinical studies and make modifications, as necessary
  • Guide and oversee study protocol to anticipate potential problems that may arise during the clinical trial in close collaboration with a CRO.  A clear understanding of the study objectives is mandatory to ensure appropriate and accurate study performance and oversight
  • In collaboration with medical monitor for study and VP of R&D, create and lead the development of study plans and study-specific working practices
  • Develop, manage, and maintain relationships with CROs, clinical sites, CRAs and other partners/vendors, as applicable
  • Facilitate effective communication between study sites and study team members to ensure successful completion of clinical trials
  • Train CRAs, as applicable
  • Ensure adequate monitoring to meet study objectives, train CRAs as applicable and review/approve monitoring reports
  • Acts as point of escalation for study related issues
  • Provide input/review for clinical and regulatory documents (e.g., Protocol, Informed Consent Form, Case Report Forms and patient worksheets, Source document, Investigator’s Brochure, data management plan and edit specifications, monitoring plan, and Clinical Study Report), as appropriate
  • Work closely with Clinical Document Specialist to ensure collection of proper documents for compilation/reconciliation of Trial Master File

 Requirements:

  • BA/BS/MS degree or equivalent education
  • 7+ years in the pharmaceutical or biotech industry with 5+ years of experience as a clinical project manager and at least 1 year of clinical monitoring experience is desirable
  • Experience with the conduct and management of both Phase 2 and Phase 3 trials is required; experience with the conduct of global trials is desirable
  • Experience within the therapeutic area of dermatology/pruritus and/or dialysis patients is desirable
  • Excellent written, verbal communication and presentation skills in small and large group settings a must
  • Excellent knowledge of ICH/GCP and regulatory guidelines/directives for compliance with FDA, EMA and other international regulatory agencies, as required
  • Strategic thinking and good clinical and scientific judgment
  • Excellent organizational skills, effective at problem solving and strong leadership ability in negotiation, communication and networking
  • Must demonstrate leadership skills in order to direct clinical team in study preparation and execution
  • Ability to work with collaborators within a team structure
  • Ability to effectively multi-task and prioritize
  • Ability to travel ~20 % of time
  • Financial budgeting and forecasting skills
  • Solid computer skills requirement of MS applications including (but not limited to) MS Project, Word, Excel, Power Point
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