Clinical Trials Manager

Responsibilities:
- Serve as a core member of the Clinical Trial Team (CTT) and act as deputy for the Clinical Trial Leader (CTL) during absences.
- Organize and coordinate CTT meetings (agendas, minutes, follow-up actions).
- Facilitate communication/collaboration with team members and external partners (CROs and vendors).
- Develop and maintain trial-level documents and operational plans (project management, communication, risk management, quality plans).
- Establish and manage trial-related systems/processes (e.g., central laboratories, eCOA/ePRO) aligned to protocol requirements.
- Monitor CRO/vendor performance; ensure timely and accurate data integration, transfer, and reconciliation; escalate issues to CTL as needed.
- Identify risks/issues and support mitigation strategies and action plans.
- Maintain accurate, up-to-date trial information in systems and communication tools.
- Set up and maintain clinical trial insurance in participating countries.
- Coordinate with global supply chain for timely supply/distribution of devices and investigational products/comparator/co-medication.
- Prepare/distribute trial correspondence and support materials for meetings/newsletters/websites.
- Lead logistics and support content for external meetings (investigator meetings, advisory boards).
- Ensure inspection/audit readiness; participate in internal audits and regulatory inspections as required.
- Support budget forecasting/accruals; assist with invoice tracking and processing per vendor contracts.
- Act as CTL when assigned, leading cross-functional CTT to operationalize the protocol.
- Lead development of site management oversight plan and ensure oversight (including risk management) for trials without an assigned SML.

Qualifications:
- 5+ years of trial management experience (leadership experience preferred).
- Bachelor’s degree in Life Sciences, Pharmacy, or related field.
- Experience in global clinical development.
- Oncology development experience (preferred).
- Direct health authority inspection experience (FDA/EMA/MHRA) including sponsor GCP inspections (preferred).
- Experience with outsourcing and oversight.
- Knowledge of ICH-GCP, FDA guidelines, EU CTR, and other relevant guidelines.
- Knowledge of financial planning, tracking, and reporting.
- Knowledge of trial risk assessment and management.
- Familiarity with clinical trial systems (CTMS, eTMF, EDC, IRT, eCOA) and site management metrics/KPIs/KRIs.
- Strong vendor and project management; leadership of cross-functional teams.
- Strong interpersonal, communication, analytical, and decision-making skills.
- Willingness to travel (typically 10–20%).