Opening for Reg Site Activation Manager at INC Research
INC Research is a top-tier therapeutically focused global clinical research organization (CRO) providing a complete range of Phase I – Phase IV clinical development services for the world’s biopharmaceutical companies. We proudly boast 43 of the world’s top 50 pharmaceutical companies as our customers. With approximately 5,000 employees across six continents and experience spanning more than 100 countries, we provide significant scale, scope and expertise to deliver innovative clinical development approaches and strategic alliances that meet the needs of our customers.
Post : Reg Site Activation Manager (APAC) - (17001466)
- Collaborates with major functional area leads (SSU Country Managers, Project Management, Clinical Management, Contract Leads and Patient Recruitment leads) to identify and evaluate fundamental issues pertaining to successful site activation, interpret data on complex issues, make good business decisions and ensure solutions are implemented. Ensures all project deliverables meet the internal customers’ expectations and the contracted deliverables, providing accurate projections, reports and updates, and ongoing risk assessments.
- Develops and maintains strategic relationships with customers in alignment with their assigned projects. May collaborate with business leads for business development, alliance management, contracts and proposals development, project management, and clinical management to achieve project goals. Ensures that individual project targets are met, clients are satisfied, services are provided with the highest quality standards and policies and procedures are followed. Leads or contributes to global strategic improvement initiatives across and within the SSU department.
- Provides oversight of all project SSU activities which encompasses all activities from site selection through site activation-ready.
- Assumes accountability on SSU deliverables including, but not limited to:
- Start-up regulatory activities (submissions, communication to competent authorities/ethics committees import licenses, study maintenance submissions);
- Essential document collection leading to site activation;
- Overall SSU timelines to site activation.
- Develops plans in accordance with Standard Operating Procedures and/or sponsor-scoped process. Complies with 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, project PM, and the SSU Business Unit Controller against project milestones and budget to ensure project profitability. Takes corrective measures where necessary to keep project in line with budget and gross profit expectations.
- Uses professionally recognized tools for planning and management of scope, timeline, resources, and ensures that minimum hours are used for tasks. If out-of-scope work is requested, notifies the project PM and her/his SSU manager and track out of scope until assigned to back log.
- Prepares the core submission documents and core clinical trial application dossier.
- Produces master Patient Information Sheet (PIS) /Informed Consent Form (ICF) in collaboration with the PM and medical department.
- Oversees collation, quality review, and submission of country-specific applications.
- Accountable for the timely follow-up for Ethics Committee/Competent Authority enquiries or objections in collaboration with the country SSU Specialists. 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. In parallel with project deliverables, identifies best practices and initiates/participates in process improvement initiatives in conjunction with the global SSU leadership plan.
- Participates in new business development activities including participation at client presentations. Reviews proposals, attends client sales-focused meetings, and provides information to support business development activities.
- Actively participate in team meetings. Designs presentations and delivers information in a way that allows the audience to understand the information and interact appropriately.
Performs other work-related duties as assigned. Minimal travel may be required (up to 25%)
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