Study Management Associate (PM)

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

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, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.

We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.

We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Job responsibilities

Project Administration

? Creates and maintains the Trial Master File Management (TMF) Plan. Routinely reviews the TMF to ensure quality, completeness and inspection readiness

? Coordinates and monitors the activities associated with study deliverables across all applicable internal functional departments and vendors.

? Assists with activities associated with interim analyses, database snapshots and locks, final CSR and study closure

? Assists with identification of and contracting with approved vendors, as necessary

? Provides vendor management, inclusive of ensuring key deliverables are met, potential scope creep is identified and change orders are developed, as necessary

? Assists with development and implementation of change orders

? Assists with resource management and team member transition by collaborating with appropriate Resource Managers and ensuring detailed Transition Plans are developed and implemented efficiently

Financials/Reporting

? Develops contingency planning and risk mitigation strategies to ensure meeting or exceeding study milestones.

? Creation and maintenance of metric reports, inclusive of data collection from multiple sources, for delivery to client or senior management

? Assists with overall financial performance of the study by interacting with internal functional departments or vendors to obtain required metrics for financial reporting

? Attends financial review meetings to assist with reconciliation and identification of budget overrun

? Reviews and approves invoices from sites or vendors and to the client

Business Development

? Participates in representing the company to the client, ensuring satisfaction levels are met and statuses of deliverables are communicated effectively.

? May participate in Customer proposal development

? In collaboration with the Project Team, will plan, coordinate and present at internal and external meetings

Knowledge/Training

? Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training

? Develops knowledge of current therapeutic environment

Qualifications

What we’re looking for

? Bachelor’s Degree (or equivalent) level of qualification in Life Sciences, Medicine, Pharmacy, Nursing or related field equivalent preferred

? Prior experience in a contract research organization (CRO), pharmaceutical, or biotechnology company preferred. 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

? Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince and persuade

? Flexibility and ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment

? High level of competency in English language

? Proficiency with MS Office Applications

? Ability to travel as necessary (up to 25%)