SENIOR SPECIALIST, CLINICAL QUALITY ASSURANCE (GCP)
Position Summary:
As a key member of the Clinical Quality Assurance function, this individual will serve as a tactical quality professional in supporting compliance related to Good Clinical Practice (GCP), Good Pharmacovigilance Practices (GVP) and other related activities. The individual will be critical in providing compliance support to Clinical Development (Clinical Operations, Data Management, Biometrics, Regulatory Affairs, Clinical Science, Pharmacovigilance and Risk Management, and Medical Affairs). Scope also includes assisting with the GCP/GVP audit programs and developing, maintaining and continuously improving the GCP/GVP Quality Systems.
Essential Duties and Responsibilities:
- Promote a culture of compliance and quality
- Coordinate and participate in continuous improvement of quality processes and systems that assure compliance of clinical study-related activities conducted by and in collaboration with contract research organizations
- Contribute to effective oversight of systems cross-functionally in clinical research and development in collaboration with matrix team members. Attend Study Execution Team (SET) Meetings as required
- Administer and support execution of the Clinical Development Compliance Charter
- Administer and support execution of Clinical Quality Agreements
- Administer and support execution of Clinical Quality Oversight Plans
- Participates in the administration of Audits and CAPA system. Ensures adherence to the approved Annual Internal Audit Schedule and External Audit Schedule. Ensures the corresponding workflows and documentation are maintained per procedures
- May train company staff on clinical practices and procedures, such as initiating internal deviations and CAPA and requirements of vendor owners
- 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 and administer the planning, execution and follow-up of effective audits of investigator sites, pharmacovigilance vendors, documents (Protocol, IB, Master Template Inform Consent, CSR), Trial Master Files, and internal processes
- Support GCP and GVP inspection readiness
Qualifications:
- Bachelor’s degree preferred
- 7+ years of experience in Clinical Quality Assurance, Quality Assurance or Clinical Operations Role. Broad knowledge of risk-based quality systems approaches consistent with ICH E6 for Good Clinical Practice. Experience with all phases of clinical trials
- Knowledge of Good Clinical Practices (FDA and ICH), Pharmacovigilance (FDA and EMA), a solid understanding of 21 CFR Part 11 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 resulting in successful agency (FDA, EMA) inspections
- Ability to travel both domestic and internationally, as needed. Expected travel up to 10%