Responsible and accountable for the customer-focused leadership andmanagement of Site Start-Up (SSU) deliverables within a region or globally,within the assigned projects or programs.
Directs the technical and operational aspects of the Site Start-Up deliverablesof the assigned projects.Accountablefor the delivery of activation-ready study sites on time, on budget, and incompliance with all applicable regulations.
Responsible for overseeing all Site Start-Up activities from siteselection / recommendation through site-activation ready.
Develops integrated SSU timelines and reportsweekly progress including plans to address potential risks / gaps to the projectteam, Project Manager (PM), SSU Management and Project Sponsor.
Ensures all project deliverables meet the internal and customers’ expectations as per contracted deliverables, providing accurate projections, reports and updates, and ongoing risk assessments.
Ensures that individual project targets andclient needs are met, services are provided with the highest quality standards,and policies and procedures are followed.
Contributes to change initiatives across and within the SSU department.
Takes corrective measures where necessary to keep projects in line with budget and gross profit expectations.
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.
Meets or exceeds the planned submission / approval timelines; if forecasted timelines are not reached or if any potential issue is identified, solves or escalates the problem quickly.
Includes coordination of internal and external stakeholders in thedevelopment and / or provision of required clinical trial agreement templates andinvestigator site budgets, oversight of local contract negotiator colleaguesand assistance in resolving negotiation barriers, and periodic progressreporting to the client and other stakeholder groups.
Other Responsibilities :
Ensure all relevant documents are submitted to the Trial Master File(TMF) as per Company SOP / Sponsor requirements.
Performs otherwork-related duties as assigned. Minimaltravel may be required (up to 25%).
QUALIFICATION & REQUIREMENTS
Bachelor’s Degree, Higher Degree Preferred. Minimum 4 years CRO industry experience and / or a minimum 3 years’ experience working in a SSU, or clinical trial environment or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job.
Experience with leading / co-leading at least 5 studies from award and into maintenance; at least 2 of those studies must have included more than 10 countries across multiple regions.
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 Contribute to a training and Quality assurance plan within SSU and update SOPs / WI.