
Project Manager II
4 semanas atrás
Project Manager II - Brazil at Syneos Health
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model centers the customer and patient, with teams that collaborate to simplify and streamline work. We are agile and driven to accelerate the delivery of therapies to change lives. We have 29,000 employees across 110 countries.
Responsibilities- Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOPs, and regulatory requirements.
- Acts as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to contractual agreements.
- Lead project team 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 quality and completeness of TMF for assigned projects; maintenance of study information on databases and systems; study management components of inspection readiness; 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 potential project manager.
- Management: may be required to line manage other project management team members and clinical monitoring staff.
- Bachelor's Degree (or equivalent) in life sciences, Medicine, Pharmacy, Nursing or equivalent.
- CRO and relevant therapeutic experience preferred; strong knowledge of Good Clinical Practice/ICH guidelines and regulatory requirements.
- Strong organizational skills and 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%).
- Seniority level: Mid-Senior level
- Employment type: Full-time
- Job function: Project Management and Information Technology
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks at any time. The Company will determine what constitutes equivalent qualifications and will comply with applicable laws and accessibility requirements. The Company is committed to compliance with the Americans with Disabilities Act, including reasonable accommodations when appropriate.
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