Skip to Main Content

Assistant Director of Clinical Operations

Green Key Resources Remote, OR

  • Posted: over a month ago
  • Full-Time
  • Benefits: vision, dental, medical
Job Description

Responsibilities:

  • Global experience with Rare Disease, Neurology, or CNS preferred.
  • Managing all operational aspects for implementation of clinical trial activities from study start-up through database lock, ensuring GCPs, regulations and relevant SOPs are met.
  • Coordinating the negotiation of budgets and providing oversight for payments per vendor contracts.
  • Reviewing monitoring reports, protocol deviations and data listings for sponsored studies to ensure reliable quality data are delivered; coordinating with CROs on site selection, IRB submissions, site initiation and close-out planning.
  • Tracking patient recruitment and progress to study timelines; supporting safety reporting; maintaining and reporting metrics for clinical study and CRO delivery performance.
  • Performing and/or overseeing site monitoring visits for clinical trials as needed Ensuring clinical supplies accountability records are maintained.
  • Providing oversight to staff maintaining clinical trial master files to ensure their compliance with required regulatory and GCP quality standards and consistency with company SOPs.
  • Participating with CROs and providing support to sites to prepare for clinical audits and to respond to audit findings conducted by internal QA and external regulatory agencies.
  • Compile study progress reports to upper management.

Qualifications:

  • Bachelor Degree in health or biologic science (BS/BA/ BScN or higher).
  • A minimum of 8+ years clinical study management experience in biopharmaceutical industry; global clinical trial experience is highly preferred.
  • Advanced knowledge of Good Clinical Practices and current knowledge of FDA regulations for IND clinical trials is required; international clinical trial experience and knowledge of other country regulatory requirements is preferred.
  • Effective oral and written communication, and interpersonal skills are required.
  • Advanced computer skills including proficiency in MS Office are required.

 

Company Description
Premier executive recruitment firm specializing in permanent placement, contract consulting, temp-to-hire and temporary staffing within the following specialty areas: accounting-finance, healthcare nursing & allied health, pharmaceutical, financial service operations, information technology, creative, hospitality, office/legal support and human resources across our offices nationwide.

Our recruiters are highly-specialized consultants who only recruit within specific job disciplines. Each of our division leaders has over a decade of direct experience working in the industries they serve. The bottom line is that we understand your business, your challenges – and most importantly what it takes to source and successfully hire top talent. When you’re looking to hire people who make an immediate impact, unlock your potential with Green Key Resources.

Green Key Resources

Premier executive recruitment firm specializing in permanent placement, contract consulting, temp-to-hire and temporary staffing within the following specialty areas: accounting-finance, healthcare nursing & allied health, pharmaceutical, financial service operations, information technology, creative, hospitality, office/legal support and human resources across our offices nationwide. Our recruiters are highly-specialized consultants who only recruit within specific job disciplines. Each of our division leaders has over a decade of direct experience working in the industries they serve. The bottom line is that we understand your business, your challenges – and most importantly what it takes to source and successfully hire top talent. When you’re looking to hire people who make an immediate impact, unlock your potential with Green Key Resources.

Green Key Resources's Logo

Address

Remote, OR
USA

Website

View all jobs at Green Key Resources

What email should the hiring manager reach you at?

By clicking the button above, I agree to the ZipRecruiter Terms of Use and acknowledge I have read the Privacy Policy, and agree to receive email job alerts.