3 weeks ago

Project Manager (CTL) - Sponsor dedicated

Syneos Health

Netherlands

3 weeks ago

Apply

Syneos Health is seeking a Project Manager (Clinical Trial Lead) to join a global team based in the Netherlands, dedicated to a single sponsor partnership. The role involves leading interdisciplinary clinical research studies, ensuring compliance with GCP and regulatory requirements, and managing project delivery, budgets, and client relationships. Requires a Bachelor's degree in life sciences or related field, strong CRO and therapeutic experience, and willingness to travel approximately 25%.

On-siteFull-timeEntry LevelClinical ResearchGood Clinical Practice

Project Manager (CTL) - Sponsor dedicated

Apply

On-siteFull-timeEntry LevelClinical Research

Salary

Not specified

Work Location

Netherlands, NL

Work Model

On-site

Employment Type

Full-time

Experience Level

Not Applicable

Core Qualifications

Technical (Must-have)

Clinical researchGood Clinical PracticeICH guidelinesRegulatory requirementsProject managementBudget managementTime managementTherapeutic area expertiseTMFDatabasesInspection readinessRisk mitigationContingency planningClinical monitoring

Soft Skills

Organizational skillsCommunicationPresentationInterpersonal skillsIndependent workAdaptability to new technologiesRelationship building

Key Responsibilities

•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.

Project ManagerClinical Trial LeadBiotechnology ResearchLife SciencesCROGCPOn-siteFull-timeNetherlandsSponsor dedicated

Core Qualifications

Technical (Must-have)

Soft Skills

Organizational skillsCommunicationPresentationInterpersonal skillsIndependent workAdaptability to new technologiesRelationship building

Key Responsibilities

•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.