Fsp Project Manager I

7 days ago

Sydney, New South Wales, Australia Syneos Health Full time

Overview
FSP Project Manager I (Sydney based) 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 the patient, and we work to simplify and streamline our processes across Functional Service Provider partnerships or Full-Service environments.
Responsibilities
Project Administration
Creates and maintains the Trial Master File (TMF) Plan and routinely reviews the TMF for quality, completeness and inspection readiness.
Coordinates and monitors study deliverables across internal functional departments and vendors.
Assists with interim analyses, database snapshots and locks, CSR finalization and study closure.
Identifies and contracts with approved vendors as needed.
Provides vendor management, ensuring key deliverables are met, addressing potential scope creep, and developing change orders as necessary.
Assists with development and implementation of change orders.
Assists with resource management and team member transition by collaborating with Resource Managers and ensuring detailed Transition Plans are developed and implemented efficiently.
Financials/Reporting
Develops contingency planning and risk mitigation strategies to meet or exceed study milestones.
Creates and maintains metric reports from multiple data sources for delivery to clients or senior management.
Supports overall financial performance by coordinating with internal departments or vendors to obtain required metrics for reporting.
Attends financial review meetings to assist with reconciliation and budget overrun identification.
Reviews and approves invoices from sites or vendors to the client.
Business Development
Represents the company to the client and communicates deliverable statuses to ensure satisfaction.
May participate in customer proposal development.
In collaboration with the Project Team, plans, coordinates and presents at internal and external meetings.
Knowledge/Training
Facilitates team training in accordance with protocol and project requirements, including therapeutic and process training.
Develops knowledge of the current therapeutic environment.
Qualifications
Bachelor's Degree (or equivalent) in Life Sciences, Medicine, Pharmacy, Nursing or related field preferred.
Prior experience in a CRO, pharmaceutical, or biotechnology company preferred. 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 independently.
Excellent communication, presentation, interpersonal skills (written and spoken).
Ability to handle multiple tasks and meet deadlines in a dynamic environment.
High level of competency in English; Proficiency with MS Office applications.
Ability to travel as necessary (up to 25%).
Seniority level
Entry level
Employment type
Full-time
Job function
Project Management and Information Technology
Industries
Biotechnology Research
Pharmaceutical Manufacturing
Research Services
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