Hybrid: GCP Consultant (234599)

Clinical Research & Clinical Affairs | Life Sciences & Technology
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Duration

2-3 months with likely extensions

Job Description

Pharmaceutical client needs a Sr. Manager of GCP for at least 2-3 months as a consultant with very likely extensions who has some experience with clinical operations, clinical trials and quality assurance to build out their GCP audit management program. Schedule, plan, implement, and track their audits. Work with the clinical operations, and research vendors at the CMO sites to plan the audit schedules and scopes. Having experience as a study coordinator or study monitor would be helpful in the role. Big focus is on audit management. There are currently 5-6 sites that need to be coordinated with and scheduled. Along with the auditing program this person needs to work on their SOP revision project. There are over 30 GCP and safety SOPS that need to go from their paper based system to their electronic system. Many of the SOPS require strong revision and many documents need formatting to be done. Having a good background with editing documents in MS Word is a must. All of this project is being tracked in Smartsheet. Person must work with the clinical, biostats, and operations teams to ensure documents are being tracked and are moving along and edits and revisions are being completed and are organized properly so having document control experience is helpful.

Skills

  • GCP, Audit management, SOPs

 

Hybrid: GCP Consultant (234599)

About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
ASAP
Location
US On-Site

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