ProClinical is advertising a vacancy for a Clinical Compliance Specialist position with a leading biotechnology company that specialises in RNAi therapeutics. The organisation uses this innovative form of therapy to treat rare genetic, cardio metabolic, acute hepatic infectious, central nervous system (CNS) and ocular diseases. The Clinical Compliance Specialist will join this company in their office in Germany. This is an exciting opportunity for an experienced and motivated applicant to develop a career in a truly revolutionary field.
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.
- Providing 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.
- Preparing team for internal audits of clinical programs, reviewing route cause analysis, and proposing reasonable remediation strategies according to relevant policies/procedures.
- Partnering with Quality Assurance on developing risk-based quality assurance strategies to support Clinical Operations activities.
- Partnering with Quality Assurance and clinical oversight roles on tracking, trending, and reporting of key quality risks to Senior Management.
- Providing support to Sr. Director with fostering and strengthening the strategic partnership relationships with CROs.
- Assisting in the review and identification of potential systemic gaps and coordinating with the appropriate stakeholder to ensure timely remediation.
- Reviewing and monitoring corrective and preventative action plans (CAPAs) within clinical operations and assists in root cause analysis and formulating responses.
- Assisting with Inspection Readiness strategy and execution for programs approaching regulatory approval submissions by partnering with QA and program Ops lead.
- Participating in process improvement initiatives for clinical operations.
- Assisting with effective cross-functional collaboration around SOP development.
- Participating in the Clinical Quality Assurance Council (CQAC), Joint Operating Committee (JOC) meetings, and program team meetings, as appropriate.
- Reviewing key study plans specific to sponsor oversight and compliance such as the Vendor Oversight Plan.
- Maintaining knowledge of regulatory agencies' activities, regulations, and guidelines relevant to Clinical Development.
Skills and Requirements:
- 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.
- Demonstrable project management skills.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Kevin Cassini at +1 215 531 5288 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
£0.00 - £45000.00 per annum
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