Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success.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.Job ResponsibilitiesCollaborates 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:Life Cycle maintenance regulatory activities (study maintenance and amendment submissions, oversight of communication to competent authorities/ethics committees, import/export license extensions)Oversight of delivery of executed amended clinical trial agreements and investigator budgets with investigator sitesOverall 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.Get to know Syneos HealthOver the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.
10 days ago