Description
The Country Study Specialist is responsible for providing project coordination and operational solutions to support Country Study Managers. The position also provides clinical trial oversight to local study teams to enable effective management of both global and local trials. The Study Start-up Specialist is responsible for all study start-up (SSU) related activities in the country/region, on assigned studies, overseeing and leading SSU activities in collaboration with other clinical research stakeholders.
Responsibilities
Study management part
- Coordinates/supports operational aspects for implementation of clinical trial activities from study start-up through database lock, ensuring the client's quality and safety standards, regulations, timelines and budget commitments are met.
- Performs/coordinates protocol and site level feasibility activities, including evaluation of patient population and final site selection (if applicable).
- Provides input into and/or develops study related materials such as Monitoring Plans, Recruitment Plans and Study Newsletters.
- Supports/coordinates the negotiation of site budgets within Fair Market Value (FMV) guidelines, budget plans and provides oversight for site payments per contract, as required.
- Maintains effective and ongoing communication with clinical study manager; supports communication with local study teams and to sites as required.
- Works with global study team and clinical study manager to manage or support the day-to-day activities of the study, including monitoring reports review, problem solving, issue escalation, timely closure of non productive sites and tracking of safety procedures.
- Supports management of country-level Trial Master File (TMF) and reviews for quality (including translations, as applicable).
- Is responsible for the coordination and oversight of local affiliate study level audit/ inspection audit action plan activities.
- Provides feedback to local vendor manager and clinical study manager on CRAs, and local supplier/vendor performance.
- Coordinates study or country communication plan.
Start-up part
- Updates knowledge on related regulatory requirements, ensures adherence and compliance with local regulations and internal procedures.
- Executes all start-up activities prior to site activation on assigned studies, according to the client's standards and aligned with study/project requirements and timelines.
- Prepares country level Informed Consent Form (ICF) and obtains ethics committees' and local regulatory authorities' approval. Prepares ongoing submissions, amendments and periodic notifications required by ethics committees and regulatory authorities as needed within the country.
- Maintains and analyzes study start-up data (metrics) on assigned studies, ensuring optimal efficiency to reduce start-up timelines and identify opportunities for continuous improvement.
- Partners with Clinical Study Managers (CSMs) and Clinical Study Specialists to provide guidance on regulatory/ethics requirements, to track and drive site activations and trial amendments submissions, by regularly reviewing and monitoring status of submissions/activations.
- Supports drug label preparation and approval (as local label representative) for studies in collaboration with local Regulatory/Quality department, as required.
- Liaises and collaborates with relevant authorities/bodies to further enhance clinical trial process, government policies/ laws, via innovative approaches
- Submits, according to local regulatory requirements, all Suspected Unexpected Serious Adverse Reactions (SUSARs), Six Monthly SUSAR Reports (SSRs) and Development Safety Update Reports (DSURs).
- In collaboration with CSMs, identifies and tracks new investigator sites performing feasibility, as applicable, and develops and supports effective patient recruitment and retention practices, as required.
- Responsible for study budget and contracts negotiation in collaboration with Contracts Manager/Associate, as required and ensures compliance with Fair Market Value (FMV) in the country.
Requirements
- University degree or equivalent; professional qualification preferably in a medical/science-related field and experience demonstrating knowledge and understanding of clinical trials.
- Monitoring experience is desirable. Previous experience managing projects is desirable.
- Demonstrated knowledge and understanding of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, Good Clinical Practices (ICH-GCP), as well as understanding of the regulatory, ethics and contractual requirements for starting clinical trials in the relevant country.