Global Trial Lead
Business Unit Manager
+32 497 71 58 10
Description de l'emploi
- Includes operational oversight of assigned project(s) at the country level for end to end project management.
- Includes start-up, execution, close-out, analysis and reporting.
- Services will ensure the teams
- operational activities are in line with country specific regulations and trial teams are delivering high quality.
- Data and trial documents/records that are compliant with the assigned clinical trial protocol, company.
- Standard Operating Procedures (SOPs), International Conference on Harmonization for Good Clinical
- Practice (ICH-GCP), and regulatory requirements Partners with the Clinical Program Leader (CPL), Clinical.
- Ensure overall study delivery at the country or countries level
- Prepare high level budget estimate in response to Request for Service’s followed by detailed budget proposal.
- Ensure accurate trial budget management, updates for scope changes and reconciliation of assigned trials for both Out of Pocket (OOP) costs and FTE costs.
- Responsible for overall contract management, including review and approval of external service provider (ESP) contracts, change orders and ensures services are delivered per contract.
- Act as primary company contact for assigned trial at the country level and ensures local/country team is tracking project progress against planned timelines and monitors patient recruitment rate to ensure that target enrollment will be met across the allocated countries. This may require development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
- Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress.
- Participate in preparation for and conduct of Health Authority (HA) inspections and internal Quality Assurance audits.
- Escalate corrective and preventive actions (CAPA) to GTL and CPL when the trial deviates from plans and communicates study progress and issues to study management teams and business partners
- Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target and works with GCO/CRO staff in the set up and coordination of Investigator meetings, if applicable.
- Deliver competent vendor management at the country level to support the study and may submit requests for vendor services and support vendor selection. This includes reviewing and approving site and local vendor invoices as required.
- As required, manage the local study drug supply.
- Contribute to patient understanding of protocol and patient safety by contributing to the review of country specific informed consent in accordance with procedural document/templates. This includes creating, reviewing and managing site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations.
- Ensure trial subject safety in that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented, as appropriate. Ensures Inspection readiness by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS and VTMF) according to expectations (metrics) and archiving retention requirements where applicable.
- With focus on quality, participates in preparation for, and conduct of, HA inspections and Internal Quality Assurance (QA) audits. Works closely with CPL to ensure CAPA is implemented for audits/inspections or any quality related issues or concerns.
- Ensures accurate finance reporting and trial delivered within budget by adhering to finance reporting deliverables and timelines. This includes forecasting and proactive management of country/local trial budget. If applicable, may assist in negotiation of trial site contracts and budgets.
- Keep the trial in compliance with local regulatory requirements by organizing and ensuring IEC/HA approvals,
- Bachelor’s degree or equivalent required, preferably in Life Sciences.
- 8 years of clinical research experience in the pharmaceutical industry or CRO
- Experience in medical affairs, working with different study types, specifically company sponsor studies.
- Specific therapeutic area experience in oncology
- Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures.
- Strong IT skills in appropriate software and company systems.
- Excellent decision-making and strong financial management skills.
- Proficient in speaking and writing in English.
- Good written and oral communication skills
- Analytical mindset - Risk management, able to foresee any risks before they happen; Proactive approach to Risk Management
- Real world evidence experience is plus
- Other preferred study experience: Collaborative studies, Outsourced to CRO, Interventional studies, Non-Interventional studies