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Clinical Project Manager
hace 2 meses
We are seeking a highly skilled Clinical Project Manager to join our team at Syneos Health, Inc. as a Sponsor Dedicated Clinical Project Manager - Home Based in Spain.
Key Responsibilities- Project Leadership and Delivery:
• Manage projects as a project manager overseeing interdisciplinary clinical research studies and ensure compliance with Good Clinical Practice (GCP), relevant Standard Operating Procedures (SOPs), and regulatory requirements.
• Act as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the Customer's and the Company's contractual agreement.
• Lead project teams to ensure quality, timelines, and budget management.
• Accountable for the financial performance of each project.
• Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues.
• Ensure studies are conducted in compliance with GCP, relevant SOPs, and regulatory requirements.
• Accountable for all project deliverables for each project assigned. - Documentation and Reporting:
• Responsible for the quality and completeness of the Trial Master File (TMF) for assigned projects.
• Accountable for the maintenance of study information on various databases and systems.
• Responsible for study management components of inspection readiness for all aspects of the study conduct.
• Oversight for the development and implementation of project plans.
• Plan, coordinate, and present at internal and external meetings.
• Prepare project management reports for clients and management.
• Develop contingency planning and risk mitigation strategies to ensure successful delivery of study goals. - Business Development:
• Develop strong relationships with current clients to generate new and/or add-on business for the future.
• May participate in bid defense meetings where presented as a potential project manager. - Management:
• May be required to line manage other project management team members and clinical monitoring staff.
- Qualifications:
• Bachelor's Degree (or equivalent) level of qualification in life sciences, medicine, pharmacy, nursing, or an equivalent combination of education and experience.
• Clinical research organization (CRO) and relevant therapeutic experience preferred. Experience in global trial project management and strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.
• Strong organizational skills.
• Strong ability to manage time and work independently.
• Direct therapeutic area expertise.
• Ability to embrace new technologies.
• Excellent communication, presentation, interpersonal skills, both written and spoken.
• Ability to travel as necessary (approximately 25%).
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.
At Syneos Health, we are dedicated to building a diverse, inclusive, and authentic workplace. If your past experience doesn't align perfectly, we encourage you to apply anyway. At times, we take into consideration transferable skills from previous roles.