Oncology Clinical Operations Manager

2 weeks ago

New York, New York, United States Astellas Full time

Oncology Clinical Operations Manager

Are you interested in joining a diverse team dedicated to advancing groundbreaking treatments for patients? At Astellas, we are committed to developing and delivering innovative and effective medical solutions that benefit patients and healthcare providers alike.

Astellas Pharma Inc. operates in over 70 countries globally, focusing on transforming innovative science into valuable medical solutions that offer hope to patients and their families. Our commitment to addressing unmet medical needs while upholding ethical standards allows us to enhance global health.

Position Overview:

The Oncology Clinical Operations Manager (OCM) acts as the primary liaison between the Sponsor and the Investigational Site. This role is crucial in ensuring that trial sites are always prepared for inspections by adhering to clinical trial protocols, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and relevant regulations from the initiation of the study through to its conclusion. The OCM will cultivate the site/sponsor relationship, facilitating clinical trial execution through effective communication and support.

Key Responsibilities:

  • Serve as the main local company contact for designated sites involved in specific trials, which may encompass both early and late-phase clinical studies.
  • Foster meaningful relationships with site personnel through consistent and collaborative communication.
  • Participate in site feasibility assessments and pre-trial evaluations as necessary.
  • Attend investigator meetings as required.
  • May take on the role of Lead OCM for particular studies, providing oversight and support to other OCMs assigned to the study, ensuring that critical study-level information is effectively communicated.
  • Drive activities related to site initiation and start-up, oversee site monitoring (including remote monitoring), manage site relationships, and facilitate site/study close-out in accordance with SOPs and policies.
  • Ensure that site staff receive adequate training and that training records are maintained accurately throughout all trial phases.
  • Guarantee compliance with study protocols, ICH-GCP, and local regulations.
  • Monitor the adequacy of site facilities and staff for the conduct of trials.
  • Ensure that source documentation and other site records comply with ALCOA-CCEA standards.
  • Collaborate with other functional areas to implement site-level recruitment strategies effectively.
  • Oversee the management of clinical supplies, ensuring proper usage, handling, storage, and documentation of returns.
  • Ensure timely data entry by site staff and resolve queries within expected timelines.
  • Maintain complete and accurate trial-related documentation and essential records in relevant management systems.
  • Document all trial-related activities thoroughly, including monitoring visits, and communicate relevant updates to stakeholders.
  • Ensure compliance with archiving retention requirements and secure storage of study files.
  • Act as a local expert on assigned protocols, developing sufficient therapeutic knowledge to support responsibilities.
  • Collaborate closely with the Clinical Trial Lead (CTL) to ensure corrective actions are implemented following Quality Assurance (QA) audits and identified quality issues.
  • Prepare trial sites for close-out and conduct final close-out visits.
  • Establish and maintain strong working relationships with internal and external stakeholders, particularly investigators and trial coordinators.

Organizational Context:

This position reports to the regional Site Management Lead within the Early or Late-Stage Site Monitoring & Management Organization. The OCM may mentor less experienced site managers and provide oversight for contract team members, maintaining a matrix relationship with study teams to ensure effective execution of responsibilities.

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