Search Jobs
Associate Director, Clinical Operations Compliance - GCP
700 Saginaw Drive Redwood City, CA 94063 US
Job Description
Associate Director, Clinical Operations Compliance - Contractor GCP
The Opportunity:
Seeking a Contractor - Associate Director, Clinical Operations Compliance, who will play a key role within Clinical Operations and is responsible for providing compliance support for sponsored clinical trials with respect Standard Operating Procedures, applicable regulatory requirements (FDA, EU, ICH & country-specific), and current industry standards and practices.
-
Support the development, revision and maintenance of applicable SOPs, processes and procedures that comply with applicable GCP standards and guidelines to support inspection readiness.
-
Identify and provide recommendations to mitigate risks to clinical study processes.
-
Be the SME for Clinical Operations personnel for issues relating to GCP, SOPs, non-compliance surveillance, Quality Events, audit/inspection responses and process optimization.
-
Partner with Clinical Operations and QA on remediation of quality issues and implementation of continuous improvement initiatives.
-
Perform quality review of clinical trial documents with a focus on compliance / regulatory requirements and risk management.
-
Provide support for Inspection Readiness activities (e.g., TMF activities, study documentation).
-
Provide strategic quality operational guidance to ensure that clinical trials are properly defined, planned, and executed across all assigned clinical stage programs through tracking, creation, deployment, and management of systems, process and procedures, training programs, GCP compliance, and regulatory inspection-readiness activities.
-
Other assigned Clinical Operations Compliance or GCP activities, as appropriate.
Required Skills, Experience and Education:
-
RN or bachelor’s or master’s degree in biological sciences or health-related field required.
-
A minimum of 8 years in GCP Quality and/or Clinical Operations experience in the pharmaceutical or biotech industry. Relevant indirect experience may also meet this requirement.
-
Experience in Quality Assurance, SOP writing, inspection readiness, CAPA preparation and successful closure.
-
Intimate working knowledge of FDA Regulations, ICH Guidelines, and GCP related to late stage or post marketed products.
-
Ability to bridge the gap between different interdisciplinary departments, and provide guidance on a compliant clinical development operations structure and team.
-
Ability to deal with time demands, incomplete information, or unexpected events.
-
Outstanding organizational skills with the ability to multi-task and prioritize.
-
Excellent interpersonal, verbal, and written communication skills, with ability to interact with colleagues and partners at all levels of experience are expected.
-
Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities.
-
Demonstrated proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint, Visio); MS Project and/or Smartsheet a plus.
-
Travel may be required (~25%).
Preferred Skills:
-
Has familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS)
-
Oncology experience, early and/or late stage, strongly preferred.
-
Knowledge and/or familiarity with Ex-US region(s) clinical trial operations.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
Share This Job:
Related Jobs:
About Redwood City, CA
Are you sure you want to apply for this job?
Please take a moment to verify your personal information and resume are up-to-date before you apply.