Clinical Trial Manager

Highly Competitive
  1. Permanent
  2. Clinical Trial Assistant (CTA)
  3. United States
Foster City, California
Posting date: 14 Mar 2019
CR.AS.22216_1552568534

ProClinical is advertising a vacancy for a Clinical Trial Manager position with a global biopharmaceutical company. This organization, which prides itself on its scientific research that has resulted in 15 marketed products and a pipeline of late-stage drug candidates and unmatched patient access programs, is seeking a driven and talent employee to join their team in California.

Reporting to the Program Manager of Clinical Trials, the Clinical Trials Manager will oversee all aspects of trial conducts, including study start-ups, enrolment, study conduct, and closeout. They will also be expected to remain knowledgeable on clinical research operations, including interpretation and implementation of FDA regulations and ICH guidelines.

Job Responsibilities:

  • Overseeing all operational aspects of assigned clinical trial(s).
  • Overseeing clinical trial conduct including study start-up, enrolment, study conduct, and close-out.
  • Preparing and reviewing study-related and essential clinical study start-up documents. This includes:
    • Clinical protocols
    • Informed Consent Forms
    • Investigator Brochures
    • Pharmacy Manuals
    • Monitoring Plans
    • Laboratory Manuals
    • Patient Diaries
    • Clinical Site Procedures Manuals
    • Pharmacy Manuals
    • Case Report Forms (CRFs)
    • CRF Completion Guidelines
    • Other relevant study plans and charters.
  • Managing the study project plan, including timelines and budget.
  • Working with CROs to develop and revising study specific plans and detailed timelines and ensuring that transferred obligations and performance expectations are met.
  • Proactively identifying potential study issues/risks and recommends/implements solutions.
  • Reviewing site study documents (informed consent template and study tools/worksheets).
  • Serving as a liaison and resource for investigational sites.
  • Attending cross-functional meetings as needed to represent Clinical Operations and study-specific issues.

Skills and Requirements:

  • At least a bachelor's degree in nursing, science or health related field required.
  • At least 5 years of related clinical trial management experience.
  • Clinical research knowledge and cross-functional understanding of clinical trial methodology.
  • Proficiency in developing trial plans including site monitoring plans, risk mitigation strategies, site selection, and clinical supplies management.
  • An ability to deal with time demands, incomplete information or unexpected events
  • Must display strong analytical and problem-solving skills
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.
  • Mid-Senior Level.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Allison Stevens at a.stevens@proclinical.com, or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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