Site Activation Manager

Syneos Health, Inc.; Schweiz; A distancia; CHF 120.000 - 180.000; Jornada completa

Descripción de la vacante

Syneos Health, Inc. in Switzerland is seeking a Site Activation Manager to drive site start-up activities across sponsor partnerships, coordinating with cross-functional teams to ensure regulatory alignment and timely activation of sites.

The role includes developing timelines, managing budgets and risks, and preparing regulatory submissions for amendments, with travel up to 25% as needed.

Responsabilidades

• Identify and evaluate site start-up issues and regulatory pathways.
• Ensure all deliverables meet contracted expectations and budgets.
• Develop and maintain integrated timelines with weekly progress updates.
• Prepare core submission documents and regulatory dossiers for amendments.
• Oversee SSU deliverables and maintain the Trial Master File (TMF).
• Minimal travel up to 25%.

Conocimientos

Site Start-Up

Regulatory Knowledge

Project Management

Budgeting

Risk Management

Descripción del empleo

Site Activation ManagerSyneos 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**For one of single sponsor partnerships we are looking for a Site Activation Manager to join the team here in Switzerland. Collaborates with major functional areas including, but not limited to: Business Development, Alliance Management, Contracts and Proposals Development, SSU Country Managers, Project Management, Clinical, Data Management and Medical Writing.Identifies and evaluates fundamental issues pertaining to Site Start-Up, project regulatory pathway, successful patient enrollment, interpret data on complex issues, make good business decisions, and ensure solutions are implemented.Ensures all project deliverables meet the internal and customers’ expectations as per contracted deliverables, providing accurate projections, reports and updates, and ongoing risk identification, mitigation and management.Develops and maintains relationships with customers in alignment with their assigned projects.Ensures that individual project targets and client needs are met, services are provided with the highest quality standards, and policies and procedures are followed.Provides oversight of all project start-up deliverables which encompasses all activities for the life cycle maintenance of projects.Assumes accountability on start-up deliverables including, but not limited to:o Life Cycle maintenance regulatory activities (study maintenance and amendment submissions, oversight of communication to competent authorities/ethics committees, import/export license extensions)o Oversight of delivery of executed amended clinical trial agreements and investigator budgets with investigator siteso Overall SSU timelines following site activation. Including any realignment required due to amendment needs.Updates plans in accordance with Standard Operating Procedures and/or sponsor-scoped processes. Complies all controlled document requirements and other requirements to ensure quality deliverables.Develops and manages integrated timelines and reports weekly progress including plans to address potential timing risks/gaps.Prepares/assists and presents overall SSU strategy and status at client meetings and communicates outcomes to project team.Reviews the project SSU budget with the functional leads, PM, and the SSU Business Unit Controller against project milestones and budget to ensure project profitability. Takes corrective measures where necessary to keep projects in line with budget and gross profit expectations.Uses professionally recognized tools for planning and management of scope, timeline, and resources and ensures effective budget management. If out-of-scope work is requested, notifies the PM and SSU Manager and tracks out-of-scope work until it is assigned to back log.Prepares the core submission documents and core clinical trial application dossier for amendments during life cycle maintenance of the projects.Performs a Regulatory Impact Assessment on core amendment submission documents and communicates any risk mitigation to Sponsor/Project teams and oversees review for Regulatory Impact Assessment for 2nd level to identify gaps, highlights any risk management to Sponsor/Project teams.Assists in amendment updated development of master Subject Information Sheet (SIS) /Informed Consent Form (ICF) in collaboration with the PM and Medical Department.Oversees collation, quality review, and submission of country-specific applications.Contributes to change initiatives across and within the SSU department.Other Responsibilities:Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.Performs other work-related duties as assigned.Minimal travel may be required (up to 25%).