What are the responsibilities and job description for the Director of Clinical Research position at alirahealth?
🔗Are you being referred to one of our roles by a connection in Alira Health? If so, please apply using the referral link emailed to you. Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Job Description Summary The Client is specialized in microbiome with nutraceutical products and medical devices) is looking for a Director of clinical research, located in Paris area for a 1 year FSP. Job Description Key responsbilities: -Develop the annual clinical development plan, implement it following validation of the overall research strategy by the Scientific Decision Committee, monitor progress, and define corrective actions as needed; - Lead and oversee the design, initiation, and conduct of clinical studies through the team; ensure proper execution and provide operational support when required; - Negotiate clinical trial agreements with investigational sites, ensure appropriate documentation is shared with Legal, and secure timely contract execution by all parties; - Ensure compliance and validity of all documents required for study initiation in accordance with applicable laws and regulations, Good Clinical Practice (GCP), and defined protocols; - Prepare clinical study reports and publications, and present results internally and externally; - Provide clinical expertise to support the development of new products in collaboration with cross-functional teams; - Conduct national regulatory intelligence, analyze updates, and disseminate relevant information to the team as appropriate; - Develop, update, and implement Quality Management System (QMS) procedures related to clinical studies, ensuring proper adherence within the team; - Manage team organization and activities, support capability development, drive team engagement, and oversee administrative follow-up; - Prepare and manage the clinical budget, monitor financial performance, and address variances between forecast and actuals. Candidate profile: - MD, PharmD, PhD or equivalent; - Minimum 8 years’ experience in clinical research and study management; - Strong knowledge of GCP and applicable regulatory requirements; - Proven project management and leadership skills; - Strong analytical, synthesis, and organizational capabilities; - Excellent interpersonal and communication skills; -Fluent in French Intermediate level of English proficiency. Languages Education Contract Type Contingency Workforce Salary Range The final offer will be determined within the applicable location-specific range and will depend on the candidate’s confirmed work location, relevant experience, skills, qualifications, internal equity, and role scope. Alira Health is a global advisory firm providing consulting and research and clinical development services whose mission is to humanize healthcare and life sciences, in partnership with patients, through innovative technologies and expert guidance. From development to medical care, we complement the expertise of our Pharma, Biotech, and MedTech clients with a full spectrum of services across their entire solutions lifecycle. With offices around the world, Alira Health provides a vibrant and creative environment with benefits that include professional development, global travel, flexible work programs and more. We welcome your passion and drive, talent and entrepreneurial spirit, sense of service and teamwork. We are an integrated team of over 800 scientists, strategists, economists, clinicians, and biostatisticians representing over 30 nationalities. This broad global perspective and cultural richness has a direct impact on providing innovative solutions for our clients that lead to higher standards of care and an improved patient experience. Learn more Introduce yourself to our Recruiters! Apply to one of our open jobs or send us your spontaneous application.