Regulatory Affairs Project Manager overseeing regulatory strategies for Plant Protection at ERM. Collaborating with clients and ensuring compliance with EU regulations in the agrochemical sector.
About the role
- Project Manager at Syneos Health managing interdisciplinary clinical research studies. Ensuring compliance and leading project teams to deliver quality results.
Responsibilities
- Manages a project as a project manager overseeing interdisciplinary clinical research studies
- Ensures compliance with GCP, relevant SOP’s, and regulatory requirements
- Acts as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout
- Lead project team to ensure quality, timelines and budget management
- Accountable for the financial performance of each project
- Coordinates activities and deliverables of all study conduct partners and proactively identifies and manages issues
- Ensures studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements
- Accountable for all project deliverables for each project assigned
- Responsible for quality and completeness of TMF for assigned projects
- Accountable for maintenance of study information on a variety of databases and systems
- Responsible for study management components of inspection readiness for all aspects of the study conduct
- Oversight for development and implementation of project plans
- Plans, coordinates and presents at internal and external meetings
- Prepares project management reports for clients and management
- Develops contingency planning and risk mitigation strategies
Requirements
- Bachelor’s Degree (or equivalent) in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience
- Clinical research organization (CRO) and relevant therapeutic experience preferred
- Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements
- Prior experience as Project Manager in a CRO environment is required
- Prior experience in Phase IV is a plus
- 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%)
Benefits
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Total Self culture
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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