Sponsor Dedicated Sr. Project Specialist - Home Based Rome - ITA

📋 Description

• • Syneos Health is seeking a highly organized and dedicated Sponsor Dedicated Sr. Project Specialist to join our dynamic team, working remotely from Rome, Italy. This pivotal role is instrumental in ensuring the seamless logistical execution and overall success of clinical projects. As a Senior Project Specialist, you will be a key support to functional leads, meticulously managing and coordinating the intricate details that drive project deliverables to completion.
• • You will operate with a significant degree of autonomy, requiring minimal day-to-day oversight, and may be tasked with coordinating the activities of other Project Specialists. Your primary focus will be to support the Project Lead (PL) in ensuring that all contracted services and client expectations for assigned projects are met by the project teams, strictly adhering to executed contracts and client requirements.
• • A core responsibility involves the comprehensive setup, meticulous maintenance, and diligent closure of project files and study information. This includes managing critical data points such as Key Performance Indicators (KPIs), regulatory documents, the Trial Master File (TMF), enrollment metrics, Adverse Events (AEs) and Serious Adverse Events (SAEs) tracking, protocol deviations, site supply management, Institutional Review Board (IRB) re-approvals, and data query resolution. You will navigate and manage this information across a variety of databases and systems, ensuring accuracy and accessibility.
• • Financial stewardship is another crucial aspect of this role. You will be responsible for maintaining and distributing study-specific and financial reports. This encompasses managing vendor and site invoices, processing investigator payments (including grants and pass-through costs), and contributing to financial forecasts. Accurate financial tracking and reporting are essential for project profitability and client satisfaction.
• • You will play a key role in project communication and coordination. This may involve leading internal and external meetings as directed by the PL. Your responsibilities will extend to preparing and distributing detailed meeting minutes and action items for both internal team discussions and external engagements, such as sponsor meetings, trusted process reviews, functional team meetings, and investigator meetings. A critical follow-up function is ensuring that action items assigned to team members are tracked and brought to closure, maintaining project momentum.
• • The accurate recording and assessment of Key Performance Indicators (KPIs) within assigned systems are vital. You will work with input and oversight from the assigned PL to track these KPIs, assess their status, and communicate them effectively. Crucially, you will propose action plans to address any deviations or areas for improvement, demonstrating a proactive approach to project management.
• • You will also be responsible for preparing and providing status reports to customers, always with the oversight and guidance of the assigned PL. Clear, concise, and timely communication with clients is paramount to building and maintaining strong relationships.
• • Ensuring that all study documents are archived according to appropriate guidelines and company policies is a non-negotiable responsibility, maintaining regulatory compliance and data integrity.
• • In the realm of quality assurance, you may serve as a project representative for internal and external audits. This involves providing support for quality assurance activities, including the preparation for audits, conducting internal reviews, preparing necessary documentation, and diligently following through to resolve any actionable issues identified.
• • Furthermore, you may be called upon to serve as the primary customer contact when the Project Lead is unavailable. In such instances, you will seek input and guidance from the Project Director to ensure seamless customer support and issue resolution, upholding Syneos Health's commitment to client satisfaction.
• • This role offers the opportunity to contribute to a leading fully integrated biopharmaceutical solutions organization that accelerates customer success by translating unique clinical, medical affairs, and commercial insights into tangible outcomes. You will be part of a team that innovates collaboratively to help customers achieve their goals, accelerating the delivery of therapies and ultimately changing lives.
• • By joining Syneos Health, you become part of a global network of 29,000 employees across 110 countries, all driven by the mission of "WORK HERE MATTERS EVERYWHERE." You will be part of a company that is passionate about developing its people through career progression, supportive management, comprehensive training, and a robust total rewards program. Syneos Health is committed to fostering a "Total Self" culture where authenticity is valued, and diversity of thoughts, backgrounds, cultures, and perspectives creates an inclusive environment where everyone feels they belong.