Senior Clinical Trial Manager — Oncology Radiopharma

Aktis Oncology, Inc.

Boston (MA)

Hybride

USD 123 000 - 176 000

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Résumé du poste

Aktis Oncology is seeking a Senior Clinical Trial Manager to lead end-to-end clinical trial management from start-up to database lock in Boston, MA. You will coordinate with CROs, vendors, and clinical sites to ensure timelines, quality, and budget adherence while managing trial budgets and vendor invoices.

This role requires oncology trial experience with strong ICH GCP knowledge, and willingness to travel up to 10-20% to support global studies.

Qualifications

  • 3–5 years (or 5+ if Senior) of clinical trial management experience.
  • Oncology therapeutic area experience required.
  • Radiopharmaceutical experience preferred.
  • Strong knowledge of ICH Good Clinical Practice guidelines.
  • Operates with clinical research operational knowledge and strong project planning/management.
  • Experience managing global or regional teams in a virtual environment.
  • Proven track record in managing trials from start-up to database lock.

Responsabilités

  • Leads and responsible for overall clinical trial management from start-up to database lock for assigned studies.
  • Reviews and authors protocols, CRFs, study reports, IB, ICFs and study plans/manuals; monitors timelines.
  • Identifies project risks and develops resolution plans.
  • Participates in selection of investigators and vendors; chairs internal/external study team meetings.
  • Maintains communications with staff, CROs and sites to meet timelines, budget and quality goals.
  • Manages study budget(s); reviews vendor invoices including investigator grants and pass-through costs.
  • Collaborates with CMC and clinical supply colleagues for drug supply planning.

Connaissances

Clinical trial management
Vendor management
Budget management
ICH GCP
Cross-functional collaboration
Project planning
Global / regional teams

Formation

B.S. in Life Sciences

Description du poste

Aktis Oncology is seeking a Senior Clinical Trial Manager to lead end-to-end clinical trial management from start-up to database lock in Boston, MA. You will coordinate with CROs, vendors, and clinical sites to ensure timelines, quality, and budget adherence while managing trial budgets and vendor invoices.

This role requires oncology trial experience with strong ICH GCP knowledge, and willingness to travel up to 10-20% to support global studies.

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