Job Title: Clinical Compliance
Duties: Under the direction of the Senior Director of Clinical Oversight and Systems, the primary responsibility of the Clinical Compliance Specialist is to liaise with various clinical development functions and external groups including Contract Research Organizations (CROs) to ensure a high level of quality and consistency across the programs and assist project teams in promoting a culture of sustainable compliance and Inspection Readiness.
Summary of Key Responsibilities
• Provides day-to-day support and problem-solving expertise to clinical development functional areas to ensure business operations are conducted in full compliance with all relevant policies and procedures.
• Prepares team for internal audits of clinical programs, review route cause analysis and propose reasonable remediation strategies according to relevant policies/procedures
• Partners with Quality Assurance on developing risk-based quality assurance strategies to support Clinical Operations activities
• Partners with Quality Assurance and clinical oversight roles on tracking, trending and reporting of key quality risks to Senior Management
• Provides support to Sr. Director with fostering and strengthening the strategic partnership relationships with CROs
• Assists in the review and identification of potential systemic gaps and coordinates with the appropriate stakeholder to ensure timely remediation.
• Reviews and monitors corrective and preventative action plans (CAPAs) within clinical operations and assists in root cause analysis and formulating responses
• Assists with Inspection Readiness strategy and execution for programs approaching regulatory approval submissions by partnering with QA and program Ops lead
• Participates in process improvement initiatives for clinical operations
• Assists with effective cross-functional collaboration around SOP development
• Participates in the Clinical Quality Assurance Council (CQAC), Joint Operating Committee (JOC) meetings and program team meetings, as appropriate
• Reviews key study plans specific to sponsor oversight and compliance such as the Vendor Oversight Plan
• Maintains knowledge of regulatory agencies' activities, regulations and guidelines relevant to Clinical Development
• Proven excellence in operational strategy: experience with developing, implementing, and measuring the impact of clinical operations tools and processes
• Experience in all study phases and experience in rare medical conditions preferred.
• Previous regulatory inspection experience preferred.
• Comprehensive and current regulatory knowledge, including GCPs
• Excellent leadership and organizational skills and ability to deal with competing priorities• Effective communication skills (written, verbal and presentation)
• Innovator, willing to initiate changes, introduce new ideas, and creatively problem solve
• Proficient with MS Office Suite (Excel, Word and PowerPoint).
• Bachelor's Degree is required.
A clinical or advanced degree (RN, MPH, MS, MA, MBA, PharmD,) is preferred
• At least 7+ years of biopharmaceutical experience
ROOT CAUSE ANALYSIS
Start Date: 08/06/2019
Estimated End Date: 01/02/2020
Hours Per Week: 40.00