Clinical Trial Manager

**Clinical Trial Manager**

Global or Regional Applicability: Regional

Trial Management services provide local management of a clinical trial (s) (or Medical Affairs data generation activity) in a country or countries. Services/deliverables include operational oversight of assigned project(s) at the country level for end-to-end project management from start-up through to closeout activities. Further, services will ensure the local trial team is 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), Global Clinical Trial Support MAO (GCTA MAO), and Global Trial Leader MAO (GTL MAO), to ensure overall study delivery at the country level.

**Deliverables**:

- Services rendered will adhere to applicable to sponsor SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc.
- Complies with relevant training requirements.
- Prepares or contributes to high level budget estimate in response to Request for Service’s followed by detailed budget proposal. Ensures 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 enrolment 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. Participates in preparation for and conduct of Health Authority (HA) inspections and internal Quality Assurance audits. Escalates corrective and preventive actions (CAPA) to GTL MAO and CPL when the trial deviates from plans and communicates study progress and issues to study management teams and business partners.
- Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
- Delivers 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, manages the local study drug supply.
- Contributes 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 reviewing and managing site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations.
- 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, will work closely with GTL MAO, 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.
- Keeps the trial in compliance with local regulatory requirements by organizing and ensuring IEC/HA approvals, if applicable.
- May contribute as a mentor, champion, or representative of functional area in process initiatives, as required and if applicable.
- If applicable, region-specific deliverables will be specified.
- Advanced:

- Autonomy with execution of local trial management services.
- Depth of knowledge with local trial management services.
- Process leadership.

Metrics/KPIs: Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP) document.

**Interfaces - Primary/Other**:

- Primary interfaces: Provider Functional Manager, sponsor Point of Contact, Clinical Program Leader (CPL), Clinical Operations Head (COH), Global Trial Leader MAO (GTL MAO), Global Clinical Trial Support MAO (GCTA MAO), Site Manager (SM), GD functions, GCO country teams, Country Medical Affairs teams, Project Owners and other sponsor enterprise sectors applicable for study conduct.
- Other interfaces: Regional Quality and Compliance Manager/Specialist, Contracts and Grants Managers, Local Drug Safety Officer (where