Sr Project Specialist

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
• Get to know Syneos Health
• Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA

Benefits

Additional Information

Sr Project Specialist Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. 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 deliver - for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: 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 building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life. - We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities 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 Specialists 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 co-ordinate the activities of Project Specialists Core 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

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