Functions as a subject matter expert on all SSU-related activities in the country/region, oversees and leads SSU activities in collaboration with other clinical research stakeholders and serves as a leader for local/global SSU process improvements and patient recruitment strategies.
Main Responsibilities and Accountabilities:
Study Start-up Coordination and Execution:
Coordinate guide and assist with all start up activities prior to site activation, including but not limited to:
Site Informed Consent Form (ICF) localization and guidance in line with regulatory/health authority requirements.
Clinical Trial Health Authority application and regulatory submission process.
Contracts & Indemnity request process.
For global studies, localize global Informed Consent Form (ICF) with country requirements.
Local sample application and permit submission processes.
Maintain up to date knowledge, ensure adherence and compliance with local regulatory requirements and associated documentation.
Review, analyze and collate metrics to ensure processes are in place that drive efficiency and reduction of timelines across start up and contracts negotiation.
Ensure all start up information & requirements are kept up to date in a central repository for both global and local Study teams.
Assist with label preparation and approval (local label representative) for studies in collaboration with local regulatory department.
Track metrics and study start-up timelines to identify trends and opportunities for improvement
Liaise and collaborate with relevant authorities / bodies to further enhance clinical trial processes, government policies / laws, via innovative approaches.
Maintain currency and awareness of changes in Start Up processes across government, hospital & industry & liaise with stakeholders to resolve any SSU issues.
Proactively respond to information survey requests by government/industry bodies.
Provide continuous and proactive communication with ECs/hospital administration/industry bodies to obtain accurate and up to date information on clinical trial status and activities.
Maintain communication with local legal/regulatory/clinical operation to ensure input is sought and all internal/external requirements are met.
Provide guidance to CSMs and CSS on regulatory/ethics, track & drive site activations by regular review and monitoring status of submissions/activations.
In collaboration with vendor management and procurement, provide input as required into vendor identification, selection, and RFI/RFP process.
Liaise and share best practices with other SSU within the region/organization.
New Site Identification:
Assist with identification and tracking of new sites in collaboration with CSMs.
Perform/coordinate site level feasibility activities including evaluation of patient population and final site selection.
Provide expertise and guidance to Global and/or Local Study Team (LST) for identification, creation and implementation of specific recruitment/retention tactics & contingency planning.
Initiate patient recruitment meetings with CSM and advise on study-specific recruitment & retention needs.
Develop innovative patient recruitment/retention practices and share concepts with vendors as needed.
Provide justification/recommendation of site closure in collaboration with CSM.
Provide reports to local study teams on overall site performance as required.
Negotiate contracts and study budgets with sites during the study start-up phase to ensure finalization.
Provide local fee structures and budgetary advice as required and ensure compliance to Fair Market Value (FMV) in the country.
Collaborate with CSMs to maintain data to ensure FMV
Liaise with management / Country Study Managers (CSM) to implement budget cost containment and implement contingencies as required.
University Degree or Equivalent preferably in a medical/science-related field.
Prior work experience demonstrating knowledge and understanding of clinical trials, such as that obtained in a clinical trial monitor capacity, and experience managing projects.
Demonstrated knowledge and understanding of ICH-GCP, the regulatory, ethics and contractual requirements for starting clinical trials in relevant country.
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