Manger, Clinical Quality Assurance (GCP)

Manager of Clinical Quality

Location : Palo Alto area

Hybrid - 3 days onsite

Overview

We are currently searching for a skilled professional to join a well-known client’s team in San Francisco, California as a Manager, GCP Quality Assurance.

This hybrid role will collaborate with cross functional teams on deliverables and provide GCP and compliance-related advice to Internal Clinical Study teams.

Your work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.

Responsibilities

• Identify and prioritize audit strategies for GCP programs
• Coordinate, plan, and / or conduct clinical study-related audits (Investigator Sites, Clinical Service Providers, Internal Systems, etc.)
• Report audit findings to management with recommendations for resolution and verify appropriate corrective actions have been implemented / documented
• Conduct training for staff (GCP, Inspection Readiness training, etc.)
• Interview, select, and train employees
• Prepare and host regulatory inspections
• Write and review Standard Operating Procedure (SOPs)

Experience

• Minimum of 6 years of experience in FDA- and ICH-regulated clinical research in GCP QA required
• Formal leadership experience preferred
• Oncology experience desired
• Detailed knowledge of and ability to interpret / apply GCP, EU, FDA, and ICH regulations / guidelines
• Ability to critically analyze and communicate compliance-related information and present associated risks
• Ability to coordinate internal / contract auditors and conduct audits
• Experience auditing Investigator sites, Clinical Service Providers, and Internal Systems Audits
• Experience with regulatory inspection and inspection readiness
• Experience with Quality Management Systems
• Experience reviewing study-related documentation (protocols, clinical study reports, informed consents) and communicate findings to appropriate team members
• Ability to work independently, manage multiple priorities, and execute on goals
• Excellent interpersonal and written communication skills
• Strong analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines
• Travel required up to 25% (domestically and internationally)

EDUCATION

Minimum of Bachelor’s Degree in a scientific discipline required

To Be a Best-fit Your Strengths Must Include

• Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
• Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
• Ability to work independently and with a team : You will be collaborating and often contributing to discussions amongst internal teams;

you also work effectively without a lot of support or structure.

• Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
• Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
• Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality and Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.

Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent and Client, visit

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application.

In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

It is Advanced Group’s practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity / expression, sexual orientation / sexual preference, pregnancy / maternity, genetic information, marital status, physical / mental disability, medical condition, military / veteran status, or any other basis protected by applicable federal, state, or local law.

If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.