Fsp Project Manager I

1 week ago

Sydney, New South Wales, Australia Syneos Health Full time

Overview
FSP Project Manager I (Sydney based)
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.
We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do.
We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.
We are agile and driven to accelerate the delivery of therapies.
"
Why Syneos Health– Work here matters everywhere.
We are committed to developing our people through career development, training, and total rewards programs, and to fostering a diverse and inclusive culture.
Responsibilities
Project Administration: Creates and maintains the Trial Master File (TMF) Plan and reviews TMF for quality, completeness and inspection readiness.
Coordinates study deliverables across internal departments and vendors.
Assists with interim analyses, database snapshots and locks, CSR and study closure.
Assists with vendor contracting and change orders.
Supports resource management and transition planning with appropriate Resource Managers.
Financials/Reporting: Develops contingency plans and risk mitigation strategies to meet milestones.
Maintains metrics and reports for client or senior management.
Assists with financial performance through collaboration with internal teams and vendors.
Participates in financial reviews and assists with invoice reconciliation and client invoicing.
Business Development: Represents the company to the client to ensure delivery of deliverables and effective communication of statuses.
May participate in customer proposal development and internal/external meetings with the project team.
Knowledge/Training: Facilitates team training related to protocol, therapeutic area, and process requirements; 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)
Strong knowledge of Good Clinical Practice/ICH guidelines and applicable regulatory requirements
Strong organizational and time-management skills; able to work independently
Excellent written and verbal communication, interpersonal skills, with ability to inform, influence, and persuade
Ability to manage multiple tasks and deliver high-quality work in a dynamic environment
English language proficiency; proficiency with MS Office Applications
Ability to travel as necessary (up to 25%)
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 studies across 73,000 sites and 675,000+ trial patients.
No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.
Learn more about Syneos Health at the official website.
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