[Hiring] Site Activation Manager II @Syneos Health

Role Description

Responsible and accountable for the customer-focused leadership and management of Site Start-Up (SSU) deliverables within a country, region or globally, within the assigned projects. Directs the technical and operational aspects of the Site Start-Up deliverables of the assigned projects. Accountable for the delivery of activation-ready study sites on time, on budget, and in compliance with all applicable regulations. Responsible for overseeing all Site Start-Up activities from site selection/recommendation through site-activation ready and all maintenance activities for the life cycle of the study. Develops SSU timelines as required and reports progress including plans to address potential risks/gaps to the project team, Project Manager (PM), SSU Management and Project Sponsor.

Job Responsibilities

• 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 from site selection through site activation ready and into the life cycle maintenance of projects.
• Assumes accountability on start-up deliverables including, but not limited to:
• Site Identification and selection
• Start-up and life cycle maintenance regulatory activities (submissions, oversight of communication to competent authorities/ethics committees, import/export licenses and extensions, study maintenance and amendment submissions)
• Oversight of delivery of executed clinical trial agreements and investigator budgets with investigator sites, including any required amendments
• Establishing and overseeing Essential Document collection leading to site activation
• Overall SSU timelines, prior to and following site activation, including any realignment required due to amendment needs.
• Develops 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 site start-up timelines and reports weekly progress including plans to address potential timing risks/gaps.
• Prepares 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 backlog.
• 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 initial or 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.
• 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%).

Qualifications

• Bachelor’s Degree, Higher Degree Preferred.
• Excellent understanding of clinical trial process across Phases II-IV and ICH GCP.
• Good understanding clinical protocols and associated study specifications.
• Excellent understanding of clinical trial start-up processes.
• Project management experience in a fast-paced environment.
• Good vendor management skills.
• Strong organizational skills with proven ability to handle multiple projects.
• Excellent communication, presentation, and interpersonal skills.
• Quality-driven in all managed activities. Strong negotiating skills.
• Strong problem-solving skills.
• Demonstrate an ability to provide quality feedback and guidance to peers.

Disclaimer

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. 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.