Senior Clinical Project Manager

Senior Clinical Project Manager

Syneos Health

Remote, Spain

Job Responsibilities

Project Leadership and Delivery:

• Manages a project as a Project Manager overseeing interdisciplinary clinical research studies and/or programs and ensures compliance with GCP, relevant SOP’s and regulatory requirements.
• Acts as primary liaison and/or facilitator between the Company and the Customer to ensure project launch, conduct, and closeout according to the Customer’s and the Company's contractual agreement.
• Leads project team to ensure quality, timelines and budget management.
• Implements resource strategies to achieve project goals.
• Accountable for all project deliverables for assigned projects.
• Develops contingency planning and risk mitigation strategies to ensure successful delivery of study goals.
• Identifies and implements performance improvement and operational efficiencies.

Reporting and Communication:

• Maintains and evaluates project progress by maintaining timelines, project plans and other tracking/analysis tools.
• Produces and distributes status, resourcing, and tracking reports as well as functional area plan to customers, appropriate team members and senior management.
• Maintains effective communication with the Customer and project team through oral and written correspondence, project status reports, and monthly progress reports; ensures adequate documentation of each communication.
• Attends and presents information at internal and external project meetings.

Business Development:

• Develops strong relationships with current and prospective clients to generate new and/or add-on business for the future.
• Supports the Business Development Department by providing information on Company's capabilities, patient populations, etc. and presents Company capabilities as well as project management specific responsibilities at Customer proposal defense meetings.
• Works with Business Development and the Proposal/Contracts groups to develop proposals for Customer requested opportunities. Works with this team to develop budgets and scope of work for the final contract.

Project Administration:

• Responsible for quality and completeness of TMF for assigned projects.
• Accountable for the financial performance of each project assignment.
• Accountable for all project deliverables for each project assigned.
• 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.

Therapeutic Mastery:

• Demonstrates mastery of current business unit therapeutic environment and drug development trends and facilitates the development of knowledge for more junior staff.
• Facilitates team training in accordance with protocol and/or project requirements including therapeutic, protocol specific, and process training.

Management:

• Serves as team leader and line manages and mentors other project management and clinical monitoring staff.
• Facilitates team building and communication.
• Ability to successfully deliver a project through successful delegation and oversight of project and functional leads.

Qualification Requirements (please indicate if ‘preferred’)

• Bachelor’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience.
• Ideally Project Management qualified i.e. Prince II or PMP/equivalent.
• Strong knowledge of Good Clinical Practice/ICH guidelines, regulatory requirements, drug development process and clinical monitoring procedures.
• Strong organizational and time management skills.
• Clinical research organization (CRO) and relevant therapeutic experience preferred.
• Ability to embrace new technologies.
• Excellent communication, presentation, and interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
• Ability to travel as necessary (approximately 25%).