Sr Project Specialist

Syneos Health

286d • $42,300 - $79,900

About The Position

Senior Project Specialist (commuting distance from Ridgefield, CT) 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, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE.

Requirements

• Bachelor's Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field or equivalent combination of education and experience.
• Moderate relevant clinical research experience with an understanding of clinical drug development and clinical trial operations. Experience in a therapeutic group preferred.
• Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.
• Strong organizational skills.
• Ability to perform several tasks simultaneously to meet deadlines. Self-motivation and ability to work independently.
• High proficiency with full MS Office Applications.
• Strong communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
• Ability to travel if necessary preferred (approximately 5%).
• High level of competence in English language.

Responsibilities

• Set-up, maintain and close out project files and study information (e.g., KPIs, regulatory documents, Trial Master File (TMF), enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), protocol deviations, site supplies, Institutional Review Board re-approvals, data queries) on a variety of databases and systems.
• Maintain and distribute study-specific /financial reports (e.g. vendor/site invoices, investigator payments (grants and pass-through), forecasts, etc).
• May lead internal and external meetings as directed by the PL. Prepares and distributes meeting minutes and action items for both internal and external meetings (sponsor, trusted process, functional, investigator meetings). Follows up with team members on action items to closure.
• Records the status of Key Performance Indicators (KPIs) in assigned systems, with input and oversight from the assigned PL. Assesses and communicates KPIs for associated job tasks to PL with proposed action plan. Prepares and provides status reports to customers with oversight from assigned PL.
• Ensure all study documents are archived based on the appropriate guidelines and policy.
• May serve as project representative for internal and external audits. Provide support for quality assurance activities, including preparation for audits and internal review, preparing documentation and follow through to resolution actionable issues.
• May serve as primary customer contact when PL is out of the office. Seeks input from Project Director for customer support.
• May mentor and train Project Specialists.

Benefits

• Company car or car allowance.
• Health benefits to include Medical, Dental and Vision.
• Company match 401k.
• Eligibility to participate in Employee Stock Purchase Plan.
• Eligibility to earn commissions/bonus based on company and individual performance.
• Flexible paid time off (PTO) and sick time.

What This Job Offers

• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree