Senior Clinical QA Manager
Proclinical is currently recruiting for a Senior Clinical QA Manager with a leading pharmaceutical company located in New York, NY. As the Senior Clinical QA Manager, you will provide quality and compliance support across all clinical projects. Additionally, the position will be responsible for designing and implementing quality plans to include external Clinical QA audits of CROs/Vendors, as well as internal audit of clinical processes and procedures.
- Develop GCP compliance strategy and provide advice for assigned programs or studies.
- Support the assessment of GCP compliance risk areas and supports/implements risk mitigation measures.
- Develop and prioritize an audit strategy for assigned programs or studies.
- Plan and lead Clinical QA audits (US and international), including clinical investigator sites and CROs/Vendors to determine compliance status and identify compliance risks.
- Report audit findings to management with recommendations for resolution and verifies appropriate corrective actions have been implemented and documented.
- Partner with Clinical Development, Clinical Operations, Nonclinical, Data Management, Biostatistics, Pharmacovigilance, Legal and Regulatory Affairs stakeholders regarding compliance issues and provide compliance guidance.
- Serve as a resource in the interpretation of GCP regulatory requirements and expectations.
- Performs Clinical QA reviews of project related clinical study documents and provides feedback as appropriate.
- Support inspection readiness efforts.
- Support the development and implementation of standards, policies, and procedures for GCP regulatory compliance.
Skills and Requirements:
- BS/BA degree in scientific discipline or a minimum of 7-10 years of experience in GCP Quality Assurance.
- Experience with all phases of clinical trials.
- Strong knowledge of Good Clinical Practices (FDA and ICH) and the ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner.
- Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks.
- Ability to multi-task and shift priorities quickly while working under tight deadlines.
- Skilled in developing collaborative internal and external relationships.
- Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
- 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.
- Ability to travel both domestic and internationally, as needed.
If you are having difficulty in applying or if you have any questions, please contact Ysabel Capitan at (+1) 347-293-1123 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.