Execute and support day-to-day clinical trial operations in alignment with protocols, timelines, and regulatory requirements.
Serve as a key point of coordination across internal teams, CROs, and external partners.
Maintain and oversee the Trial Master File (TMF), ensuring completeness, accuracy, and audit readiness.
Lead TMF quality control activities and proactively address gaps.
Support audits and inspections, including preparation and follow-up activities.
Coordinate and oversee vendors, including central labs and specialty service providers.
Manage biospecimen tracking, logistics, and associated documentation.
Monitor vendor performance and escalate issues as needed.
Develop, maintain, and improve study tracking tools (e.g., enrollment, sample tracking, timelines).
Ensure data accuracy and timely reporting across study activities.
Contribute to improvements in clinical operations processes and systems.
Drive clear, timely communication across study teams and stakeholders.
Plan and facilitate study meetings, including agenda development, minutes, and follow-up actions.
Maintain version control and documentation across clinical materials.
Support invoice tracking, purchase order coordination, and budget-related activities.

BS/BA/RN Degree with 6+ years of experience in a life science or a health-related field is preferred.
3+ years working on phase I-IV clinical studies within a biopharmaceutical/biotech, CRO, or academic environment.
Experience and understanding of clinical trial operations, preferably in oncology and/or cell therapy space.
Solid knowledge of ICH/GCP and regulatory requirements.
Excellent planning, coordination, and time management skills
Excellent oral, written, and visual communication skills.
Ability to build and maintain productive relationships at all levels within and across internal teams, and with external partners.
Collaborative and accountable – recognizes success requires teamwork and interdisciplinary thinking; shares feedback and ideas to facilitate better outcomes
Self-motivated, with a proven ability to meet objectives, timelines, and high standards managing multiple responsibilities in parallel.
Flexible
adapts to change in a fast paced, rapidly developing environment
Curious and humble – continuous learner, seeks and welcomes input/expertise of others
Tenacious and resilient – is not easily overwhelmed by challenges, delivers on commitments, operates with urgency.

Senior Clinical Trial Associate - Oncology

Key skills