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11 days old

Senior Clinical QA & PV Manager

Kelly Services
San Francisco Bay Area, CA
Clinical QA & PV Senior Manager

Hybrid

San Francisco Bay area

6+ month contract (Possibility to go perm)

In this role, you will provide direct support to the Associate Director Clinical Quality Assurance (CQA) in managing compliance related to cGCP, pharmacovigilance and other related activities.

The individual will provide compliance support to Clinical Development (Clinical Operations, Data Management, Biometrics Data Science, Safety/PV), overseeing the GCP audit programs and developing, maintaining, and continuously improving the GCP Quality System.

You will provide input and oversight to ensure all documentation, processes and systems meet our compliance requirements and are effectively monitored and maintained.

You will use your expertise in FDAs (21 CFR parts 11, 50, 54, 56 & 312) and global compliance standards (ICH- E6 R1 & R2, ICH E2A, E3, & E8) to ensure compliance across and interpret the requirements to Clinical-Ops, Data Management, RA Quality Assurance and Safety/PV department.

You will also plan requirements, identify risks, manage schedules, and communicate clearly with all project and clinical stakeholders.


**Essential Duties and Responsibilities:**


+ Support continuous improvement of quality processes and systems that assure compliance of clinical study-related activities, and in collaboration with contract research organizations and in-house clinical development.

+ Ensure all safety reports are triaged, processed, reviewed, and submitted in accordance with global regulatory requirements and standard operating procedures.

+ Lead the quality review of SAEs and SUSARs following safety case data entry by Santen or vendors providing Safety services. Specific focus on the accuracy of narrative to reflect source documentation, MedDRA coding, and appropriateness of queries to seek follow-up from the clinical sites

+ QA Oversight of reconciliation of safety data with external teams (Drug Safety &, Biostatistics)

+ Support preparation Reviews of periodic safety reports (e.g., PADER, PSURs, DSURs) in accordance with regulatory requirements

+ CQA to ensure global internal and clinical site and service provider compliance with current GCP & GVP regulations.

+ Provide safety content review of clinical protocols, study reports, Investigators Brochure, informed consent forms, and other related documents, as applicable

+ Track & Ensure PV compliance metrics

+ Design Clinical QA folders for all development studies that is easy to navigate and identify. Locate current and archive files from Quality documentation system (VQD-Veeva vault) and file into new filing system. Maintained Clinical Quality documentation

+ Support preparations for and follow-up of effective audits of investigator sites, essential documents (Protocol, IB, Master Template Inform Consent, CSR), Trial Master Files, vendors, and internal processes.

+ Provide effective oversight of systems cross-functionally in clinical research and development in collaboration with matrix team members (attend internal Study Team Meetings and corresponding external study meetings

+ Ability to identify, evaluate, and communicate risks to Clinical Quality Assurance processes and/or systems with recommendations for resolution

+ Support training staff and external partners in compliance, current clinical practices and procedures

+ Maintained annual Internal audit schedule and external Audit Schedule into Annual audit plan. Manages corresponding workflows ensures documentation is maintained per procedures. Assist in vendor audits and CAPA follow-ups and closure.

+ Promote collaboration internally and with external partners to ensure all systems, processes, and their outcomes comply with applicable international and national standards, regulations, and guidelines.

+ Support GCP inspection readiness & Provide in-house GCP training.


**Qualifications:**


+ Bachelors degree in a scientific field preferred

+ 6+ years of experience in Clinical Quality Assurance, Quality Assurance or Clinical Operations Role (Pharmaceuticals or Biotechnology).

+ Broad knowledge of risk-based quality systems approaches consistent with ICH E-6(R1 &R2) for Good Clinical Practice.

+ Experience with all phases of clinical trials

+ Knowledge of Good Clinical Practices (FDA and ICH), a solid understanding of 21 CFR Part 11, 50,54,56, & 312 with respect to clinical systems, including database, eCRF validation procedures, eCTD Quality Assurance, and eTMF requirements

+ Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner.

+ Attention to detail as well as a crisp, clear and concise style in written and oral communications.

+ Demonstrated ability to work independently and flexibly in a fast-paced, high growth environment

+ Experience supporting inspection-readiness activities (FDA, Health Canada, & EMA) is a plus.


\#P2


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

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Posted: 2022-09-19 Expires: 2022-10-20

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Senior Clinical QA & PV Manager

Kelly Services
San Francisco Bay Area, CA

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