Project Management Coordinator
Callstack
Project Manager II – Early Phase Development
Syneos Health
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇵🇱 Poland
Visit company websiteJob Level
Mid-LevelSenior
Tech Stack
Google Cloud Platform
About the role
- Manages a project as a project manager overseeing interdisciplinary clinical research studies and 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 according to the Customer’s and the Company’s contractual agreement.
- 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 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.
- Plan, coordinate and present at internal and external meetings.
- Prepare project management reports for clients and management.
- Developing contingency planning and risk mitigation strategies to ensure successful delivery of study goals.
- Develops 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.
- May be required to line manage other project management team members and clinical monitoring staff.
Requirements
- Bachelor’s Degree (or equivalent) level of qualification 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
- 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
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
project managementclinical researchGCPSOPregulatory compliancefinancial performance managementrisk mitigationstudy managementdatabase managementinspection readiness
Soft skills
organizational skillstime managementindependent workcommunication skillspresentation skillsinterpersonal skillsrelationship buildingteam leadershipproblem-solvingcontingency planning
Certifications
Bachelor’s Degree in life sciencesBachelor’s Degree in MedicineBachelor’s Degree in PharmacyBachelor’s Degree in Nursing
