I am Swetha, a Technical Recruiter with Della Infotech. I am reaching out to see if you d be open to reviewing a role we re currently supporting. I ve included the key details below if the position aligns with your experience, feel free to share your updated resume
Job Tile: Clinical Quality Project Manager
Location : Remote
Duration : 1 year
Job Description
Primary Function of Position
The Project Manager, Clinical Affairs Clinical Quality is responsible for providing oversight for clinical quality and compliance activities across U.S. and global clinical studies, including first-in-human, pivotal trials intended for regulatory submission, and post-market studies.
This individual will support the development, maintenance, and continuous improvement of clinical quality processes, operating procedures, best practice guidelines, and oversight frameworks to ensure alignment with internal requirements and applicable external regulations, including 21 CFR, ISO 14155, and other regional or local requirements.
As a key cross-functional partner, this role will collaborate closely with Regulatory Affairs, Quality Compliance, Program Management, Clinical Affairs, Post-Market Surveillance, Regulatory Compliance, Training, Legal, and other stakeholders to strengthen inspection readiness, support compliance execution, and enable achievement of business and clinical quality objectives.
Roles and Responsibilities
Accountable for supporting assigned clinical quality compliance activities, including:
- Audit & Monitoring: Conduct routine internal/external audits and ongoing clinical file or documentation reviews to identify compliance discrepancies to ensure sponsor audit/inspection readiness.
- Regulatory Compliance: Provide internal oversight of clinical studies to ensure compliance to Good Clinical Practice (Google Cloud Platform) guidelines, FDA regulations, ISO14155 standards, and other applicable global requirements.
- CAPA Management: Assist project teams with develop, implement, and track Corrective and Preventive Action (CAPA) plans to resolve audit findings and prevent future non-compliance.
- Risk Management: Identify potential clinical quality risks, escalate compliance issues to leadership, and facilitate root cause analyses (RCAs).
- Policy & Training: Support the development of Standard Operating Procedures (SOPs), best practice guidelines, clinical quality processes and tools and deliver training to ensure clinical staff are educated on quality frameworks.
- Partner with internal stakeholders to develop internal processes, KPIs and drive identified initiatives.
- Support the development and execution of a proactive, risk-based clinical quality and compliance program that safeguards participant safety, supports data integrity, and promotes continuous improvement across all clinical studies.
Qualifications
Skill/Job Requirements
Competency Requirements
(Competency is based on education, training, skills and experience.) In order to adequately perform the responsibilities of this position the individual must have:
- Minimum Education: Bachelor's degree in a scientific/bioengineering field (B.S.) with a minimum of 5 years of experience in clinical research.
- Strong organizational and project management skills, with strong experience of collaborating with cross-functional teams.
- Prior experience working in Clinical Quality Compliance.
- Strong knowledge of 21 CFR Part 812, Good Clinical Practice (ICH/Google Cloud Platform), ISO14155 and other regulations/guidelines.
- Fundamental knowledge of clinical research and monitoring requirements.
- Previous experience supporting internal and external audit on clinical studies is preferred.
- Strong communication, presentation and interpersonal skills with high attention to detail and organization.
- Ability to learn quickly, tailor to shifting requirements.
- Results-driven attitude and strong problem-solving skills, consistently show dedication or strong work-ethic to help meet aggressive timelines or multiple projects when necessary.
- Must be able to travel 25 40% or based on business requirements.
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