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Search for Jobs by Diane Brescia

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Associate Director - Clinical Trial Operations  (Science & Biotech)
South San Francisco , CA 94080
Recruited by: Diane Brescia | Recruiter | DOCS See all my Jobs

  • Hiring Company: DOCS
  • Industry: Science & Biotech
  • Compensation: To Be Determined
  • Expires: May 12, 2019
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Job Description

Oversee, lead, and manage cross-functional team resources and external service providers (including clinical operations, medical monitoring, safety, data management, auditors, and consultants) to conduct trials on time, on budget, in compliance, and of highest quality.
Coordination/execution of all operational aspects of clinical studies (including identification and management of vendors, availability of clinical supplies at the sites, review and approval of request for investigational test articles).
Work collaboratively with cross functional internal and external teams including regulatory affairs, medical writing and biostatistics
Identify, qualify, audit, and manage all external vendors, including CROs. Take initiative to continually monitor each external vendor in performance management, escalate issues where appropriate, and make the appropriate changes in order to ensure trial conduct is completed in compliance and meets company’s business objectives.
Ensure clinical trial team and clinical trial sites are properly trained and in compliance protocols, drive site selection, and patient recruitment programs that deliver enrollment targets. Performs site monitoring with field team, as needed.
Facilitates all start-up activities including but not limited to investigational site contracts, investigational site, and ethics committee submissions.
Facilitate confidentiality agreements, negotiate study agreements and budgets with sites and external vendors.
Responsible for writing, reviewing, and/or approving clinical project deliverables such as scope definition documents, investigational product labeling/kitting, Pharmacy Manuals, informed consent, IRB submissions/approvals, site activations, monitoring plan and tools, CRFs, DMP, edit checks, safety plan, DMC charter, close-out plans, and CSRs.
Assist with the development of presentations, handouts, and coordination of Investigator Meetings.
Drive site selection and patient recruitment programs that deliver enrollment targets.
Responsible for ensuring the trial is “audit ready” at all times.
Work with appropriate team members to ensure that all TMF-related documentation is current, on-file at respective site, CRO, and sponsor locations throughout trial conduct. Notify and prepare team for regulatory agency audit and address any audit observations appropriately and in a timely manner.
Advanced degree, or BS degree in science, nursing, health or related field
Experience and Skill Requirement:

Minimum of 10 years of clinical research and/or clinical project management experience in domestic and international clinical trials.
Excellent working knowledge of ICH GCP guidelines, CFR, EMA, and HIPAA regulations.
Able to work independently and make appropriate strategic decisions to operationalize and move the clinical trials forward.