About the Company:
A clinical-stage company focused on the development of advanced targeted therapies for cancer treatment. The company is rapidly growing and has a strong pipeline of precision medicine.
Role Overview:
The Clinical Trial Manager (CTM) will oversee all aspects of clinical trial activities, ensuring compliance with regulatory standards such as ICH GCP, and play a vital role in managing trial timelines, budgets, vendor oversight, and documentation. The CTM will collaborate closely with internal teams and external partners to execute clinical trials on time and within budget, contributing to the success of multidisciplinary teams.
Responsibilities:
- Track and report clinical trial progress, ensuring adherence to timelines, budgets, and contracts.
- Plan, implement, monitor, and report on clinical trial progress in accordance with Standard Operating Procedures (SOPs).
- Lead a cross-functional study team, ensuring effective teamwork while managing trial timelines, budgets, resources, vendors, and strategy.
- Contribute to the preparation of essential documentation and initiatives for process improvement.
- Collaborate with both internal and external stakeholders to manage trial timelines, resources, budgets, and vendor relationships.
- Serve as the primary point of contact for Clinical Research Organizations (CROs), clinical sites, and vendors.
- Ensure risk mitigation strategies are in place, regularly monitored, and escalate issues as needed.
- Forecast and track trial scope changes, adjusting the budget and planning for the long term.
- Perform other duties as required by business needs.
Requirements:
- A minimum of 12 months experience in managing international clinical trials within the pharmaceutical or CRO industries.
- Ability to work 2 days a week on site (Oxford)
- Oncology clinical trial experience is required.
- Ideally with sponsor experience but open to CRO backgrounds too.
- Solid knowledge of ICH GCP and international regulatory guidelines for clinical development programs.
- Excellent decision-making, facilitation, communication, and organizational skills.
- Proven ability to work collaboratively within cross-functional teams and manage external vendor relationships.
- Ability to effectively prioritize multiple competing tasks in a fast-paced environment.
- Proficiency with computer programs, including Excel, Microsoft Project, and PowerPoint.
- Eligible to work in the UK (without sponsorship).
- Occasional domestic and international travel may be required.
Contact Detail:
Discera Search Recruiting Team