Job description

Overview

Skills Alliance is currently supporting a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer. This biopharmaceutical company is passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy to deliver life-changing treatments to patients.

Role Summary

The Clinical Site Manager (CSM) is responsible for building and maintaining strong relationships with clinical sites to ensure the successful delivery of all site level activities. With full responsibility for the clinical site(s) from start up through close out, the CSM will partner with Investigators and site staff to ensure the quality and integrity of clinical data.

Key Responsibilities:

• To act as the client's key contact at assigned sites for all of their protocols being run at the site(s)
• Utilize trial management expertise and problem-solving skills to oversee overall integrity of the studies, whilst promoting positive working relationships with the site and staff
• Participate in study start up activities to include ethics/regulatory & training and where required, provide support for site contracts and budgets
• Conduct site selection visits, initiation visits, on-site monitoring visits and close out visits; generate timely visit/contact reports associated with each of these visits.
• Review the performance of studies at assigned sites ensuring the rights and well-being of patients are protected in accordance with the protocol
• Ensures data entry and query resolution in accordance with agreed timelines
• Identifying and reporting protocol deviations
• Develop patient recruitment strategies in partnership with the clinical site to meet enrolment targets and timelines
• Ensure compliance with standard operating procedures, protocol/amendments, GCP and the applicable regulatory requirements
• Monitor completeness and quality of regulatory documentation and perform site document verification escalating issues as appropriate
• Ensure electronic Trial Master File site documentation is complete
• Track site accruals and payments, providing monthly updates to the LCSM
• Support accurate and timely reporting of SAEs/AESIs by their sites
• Prompt escalation of issues to LCSM/CPM
• Facilitate communication with third party vendors to resolve issues/queries

Experience

• Degree educated (biological science, pharmacy or related healthcare discipline) or equivalent experience
• Substantial site management experience with a solid understanding of clinical trial methodology and terminology
• Experienced in the set up and monitoring of oncology studies – haem-oncology or cell therapy experience desirable
• Experienced in early and late phase (phase I-III) site management and monitoring
• Experienced in all aspects of site management from site qualification through to close out – to include start up activities (and where required: ethics/regulatory, site contracts, site budgets

Job Type: Full-time

Schedule:

• 8 hour shift

Education:

• Bachelor's (Preferred)

Experience:

• Site Management: 4 years (Preferred)

Work Location: Remote

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