Clinical Compliance Specialist
A Clinical Compliance Specialist is needed for a pharmaceutical corporation located in Cambridge, MA for a 5-month contract. 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.
The Clinical Compliance Specialist will be responsible for: 1) team preparation for internal audits of clinical programs, review route cause analysis and propose reasonable remediation strategies according to relevant policies/procedures. 2) Partnering with Quality Assurance on developing risk-based quality assurance strategies to support Clinical Operations activities. 3) Provide support to the Sr. Director with fostering and strengthening the strategic partnership relationships with CROs. 4) Assisting in the review and identification of potential systemic gaps and coordinates with the appropriate stakeholder to ensure timely remediation. 5) Reviews and monitors corrective and preventative action plans (CAPAs) within clinical operations and assists in root cause analysis and formulating responses. 6) Reviews key study plans specific to sponsor oversight and compliance such as the Vendor Oversight Plan.
Duration: 5-month contract
Location: Cambridge, MA
Compensation: $65-70 per hour
- Education: 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
- 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
- Comprehensive and current regulatory knowledge, including GCPs
- Previous regulatory inspection experience preferred.
- Proficient with MS Office Suite (Excel, Word and PowerPoint
Sthree US is acting as an Employment Business in relation to this vacancy.