The Role:
Reporting to the Vice President, Clinical Operations, the Director, Clinical Operations Excellence successful candidate will be skilled at both understanding and applying global clinical compliance regulations and processes relating to clinical trials as they advance through clinical development.
Collaborate and develop strong partnership with the Quality Assurance organization and other cross functional team members across the organization, vendors, and clinical sites. The candidate will support inspection readiness efforts to manage and support a culture of proactive inspection readiness, data quality, integrity, and regulatory compliance. The successful candidate will assist the Clinical team with the development and revision of Standard Operating Procedures, Work Instructions and Templates as well as assisting with the effective development and resolution of deviations, CAPAs, audit, and regulatory inspection findings.
Responsibilities:
- Manage the development, deployment and maintenance of processes and standards, including risk assessment, adherence to regulatory requirements and guidelines.
- Remain current with new and revised regulations and trends in industry standards; support the development and implementation of internal GCP clinical compliance process improvement strategies, and create tools, initiatives or workstreams.
- Identify compliance and quality trends and areas of potential compliance risk, propose resolutions, oversee implementation of resolutions, and ensure the effectiveness of solutions across studies.
- Perform review Site Monitoring Visit reports, review issues, compile trending reports and perform Study Oversight Visits, when needed.
- Contribute to the development of tracking and reporting on KRIs/QTLs for Clinical Development.
- Ensure appropriate escalation of quality issues, potential misconduct, and significant deviations to Nuvalent Quality Assurance and relevant stakeholders.
- Liaise with Clinical Study Teams to facilitate Risk Based Quality Management activities including creation, delivery and implementation of risk assessment plans and comprehensive oversight strategies.
- Manage TMF QC, deliverables and oversight activities, quality assessments, TMF health metrics, and overall TMF lifecycle management.
- Assist Clinical Operations with inspection readiness activities by coordinating, tracking, and participating in the completion of tasks and deliverables necessary to ensure successful inspection outcomes.
- Coordinate with clinical study leads to evaluate and manage site-specific issues, ensuring escalation to Quality Assurance for serious or persistent non-compliance. Assist with the identification of audit targets at clinical investigator sites, and clinical vendors.
- Assist the Clinical Operations team with clinical trial oversight plans, review key study documents, team workflows and trial outputs to ensure clinical compliance.
- Support the Clinical Operations department and partner with Quality Assurance for the preparation of audits of internal and external partners/vendors.
- Manage and ensure consistent practices, oversight, and tracking across Clinical Operations to ensure compliance with applicable regulations, guidelines.
Competencies:
- Strong interpersonal and communication skills.
- Ability to think critically with strong attention to detail.
- Recognized leader who exhibits effective communication, EQ, and influencing skills, within a matrix operating environment.
- Demonstration of strategic thinking and high-level planning while also balancing the ability to manage and execute operational details.
- Ability to effectively manage multiple projects with competing priorities.
Qualifications:
- Minimum of 10+ years relevant experience in clinical research with direct clinical compliance oversight.
- Bachelor’s level degree in life sciences or related field or related experience.
- Experience in Inspection Readiness preparation required.
- Documented training, advanced working knowledge, and application of current Regulations, and ICH GCP guidelines.
- Identify areas for process improvement and lead discussions to implement change.
- Build strong relationships with peers and partners both within and across function teams.
