Sr Project Specialist

Senior Project Specialist Senior Project Specialist at Syneos Health®. Syneos Health® is a fully‑integrated life sciences services organization dedicated to accelerating customer success. Job Summary The Senior Project Specialist is responsible for maintaining and coordinating the logistical aspects of clinical projects, and provides overall support to functional leads to ensure the successful completion of project deliverables. The Senior Project Specialist supports the Project Lead (PL) to ensure the contracted services and expectations of assigned projects are carried out by the project teams in accordance with executed contracts and the customers’ requirements. Operate independently, with minimal day‑to‑day oversight, and may coordinate the activities of Project Specialists. Responsibilities Set‑up, maintain and close out project files and study information (e.g., KPIs, regulatory documents, Trial Master File (TMF), enrollment data, 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). May lead internal and external meetings as directed by the PL. Prepare and distribute meeting minutes and action items for both internal and external meetings (sponsor, trusted process, functional, investigator meetings). Follow up with team members on action items to closure. Record the status of Key Performance Indicators (KPIs) in assigned systems, with input and oversight from the assigned PL. Assess and communicate KPIs for associated job tasks to PL with proposed action plan. Prepare and provide 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 following through to resolution of actionable issues. May serve as primary customer contact when PL is out of the office. Seek input from Project Director for customer support. May mentor and train Project Specialists. Qualifications 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 (approximately 5%). High level of competence in English language. Equal Opportunity / EEO Statement The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. #J-18808-Ljbffr Syneos Health Germany GMBH