Clinical Trial Leader

South San Francisco, CA 94080

Posted: 01/18/2019 Employment Type: Contract Industry: Drug Development - Med/Clinical Affairs Job Number: 5442

Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world' s leading biotech companies, with multiple products on the market and a promising development pipeline.

 

Duties: 
  • Serves as a member of one or more global cross-functional
  • Protocol Execution Team(s) (PETs) through all study stages (start-up, conduct, close-out) to contribute to the accomplishment of studies outlined by the clinical development plan: Participates in developing and finalizing cross-functional activities to ensure delivery of critical clinical trial documents such as informed consent forms (ICFs), protocols, site and country budget templates, EDC, IxRS, central / specialty lab, ECG, imaging, and PRO specifications, drug supply and biomarker / sample management plans, TMF, and CSRs.
  • Liaises with cross-functional team members including the PET members to solicit input.
  • Drafts and implements study plans including; vendor oversight, risk, quality, safety, communication, trial/medical monitoring, TMF.
  • Ensures TMF creation and QC completion.
  • Supports EDC and CTMS systems and data maintenance.
  • Tracks budget, timelines, milestones, and critical study activities, identifies issues and proposes potential resolutions.

 

Skills:    

  • The capabilities required for this role are for a proven leader with the ability to manage delegated aspects of the study with minimal direction, is self-aware and takes initiative to fix and learn from mistakes, demonstrates good judgment in seeking guidance and exercises professionalism.
  • Experienced in managing aspects of one or more early development phase (I and II), global, complex, clinical studies and generally experienced in clinical research/development.
  • Highly effective verbal (including oral presentations) and written communication skills in English; effectively delivers key messages; aptitude to independently communicate with teams and stakeholders.
  • Demonstrates an aptitude to distill information from multiple sources to create meaningful insights and induces collaboration and innovative thinking study-wide.
  • Demonstrated experience in at least one therapeutic area.

 

Education:          

  • Bachelor’s degree or equivalent required (scientific or healthcare discipline preferred).
  • 5+ years of study management experience in clinical and drug development.
  • Working knowledge of GCP/ICH requirements, international regulatory guidelines, and the drug development process.
  • Other (e.g. Travel): Willingness to travel domestically.
  • Visual acuity and sufficient dexterity to constantly operate a computer and other office productivity machinery (i.e., a calculator, copy machine, and computer printer) in a stationary position.
  • Work on nights or weekends is not typically required, however, interaction on global clinical studies requires flexibility for occasional teleconferences / meetings outside of core working hours.
Apply Online
Apply with LinkedIn Apply with Facebook Apply with Twitter

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.