Description
An exciting mid-size Oncology focused company located in the heart of San Francisco is looking for a Sr. Manager/Associate Director level Clinical Complaince manager. Not only will will this person be doing audits and mentoring direct reports, but they will also be spear heading the entire clinical QA efforts. The bill rate/salary is very flexible as this role is very urgent! High level consultants are also able to apply as it can be worked as a contract or contract to hire basis!Requirements:
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Expert knowledge of technical concepts required for all aspects of GCP and GVP auditing, to include all types of GCP and GVP audits; e.g., Study Sites, Vendors, essential study documentation, Pharmacovigilance operations and databases -
Solid understanding of domestic and international pharmaceutical/Biotechnology process and auditing standards -
Extensive experience supporting regulatory authority inspections of clinical research and pharmacovigilance activities -
Hands-on experience managing quality and compliance projects and programs -
Proven ability in driving quality process improvement initiatives -
Strong leadership experience and mentoring skills to ensure CQA team members have the coaching and mentoring to increase accuracy and productivity -
Thorough knowledge and application of international requirements of Good Clinical Practice (GCP) and ICH Guidelines and GVP compliance initiatives and regulations globally -
Strong global knowledge and understanding of regulations applicable to the conduct of clinical trials and Pharmacovigilance operations -
Experience managing/supporting regulatory authority inspections -
Strong working knowledge of clinical development and operations -
Effective and balanced management skills in building and supporting highly effective teams -
Strong communicator with strong verbal, written communication and presentation skills -
Experience in providing training on key quality and regulatory compliance information -
Strong Partnering and collaboration skills -
Balanced approach to issue management and mitigation planning -
Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint) -
Clinical Quality System and Clinical computerized systems; e.g., EDC, IxRS, Drug Safety Database functionality, etc.
Education:
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Bachelor of Science Degree or higher -
Experience: Accomplished knowledge of global and local GCP and GVP regulations -
Licenses or Certifications: RQAP-GCP or other certifications are highly desirable -
Minimum of 8 to 10+ years' experience in the pharmaceutical/biotechnology industry -
Minimum of 7+ years' auditing in one of the following areas: GCP & GVP
To find out more about Real please visit www.realstaffing.com