Permanent Clinical Trial Manager Homebased
- Experience Level
Upsilon Global have collaborated with a global CRO to present an exciting permanent position as a Clinical Trial Manager. They specialise in Oncology and Rare Diseases and operate across more than 15 countries. We have been aligned with them for over 7 years now, meaning that we know the business incredibly well.
We have met with the Managing Director and Director of Clinical Operations on several occasions and continue to support them throughout their growth as they have experienced a 30% headcount increase over the past 3 years. The management team are Oncology certified and focus on educating their team with the science behind the study to promote a deeper understanding of their ongoing projects.
This forward-thinking CRO action protocol ownership, which ensures a high level of quality throughout all levels of clinical operations and means that CRA’s rarely share projects. Resulting in streamline communication and an efficient working environment.
In this role, you will be joining a passionate, experienced Oncology group and an established virtual organisation.
- The CTM will manage oncology studies, typically covering 7-8 countries and oversight of LCRAs/CRAs in said countries.
- Responsible for overall project planning and execution for early phase clinical protocols
- Responsible for the training of all site-monitors
- Ensures that protocol/project training (on-site and Investigator Meeting) for Investigators, Monitors and other key study personnel is conducted and appropriately documented.
- Responsible for the overall management of site monitoring and associated documentation from study initiation through close-out to ensure compliance with regulatory requirements and Good Clinical Practice.
- Establishes and maintains productive working relationships with vendors, clinical investigators, and clinical site study staff to ensure quality of deliverables.
- Provides guidance to study team ensuring adequate management of the project Trial Master File.
- Visits sites on regular basis to monitor compliance with the protocol. Provides mentoring, and ensures adequate training and monitoring is in place.
- Undertakes ongoing performance review, feedback and development of staff.
- Assists with talent recruitment and leads a highly motivated, efficient and effective team.
Education and Qualifications
- A Bachelor's degree in a scientific or health-related field is required.
- Master's degree in a scientific or health-related field is preferred.
- Minimum of three years CTM experience
- Minimum of five years Senior CTM experience
- Advanced understanding of GCPs and ICH guidelines is required.
Other skills and abilities
- Must demonstrate a keen attention to detail and timelines.
- Excellent writing, communication, and presentation skills.
- Demonstrated leadership and project management skills.
- Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast-paced environment.
For further information on this opportunity and to learn of similar positions, please contact Upsilon Global on +44. (0) 20. 3. 87. 5. 99. 66 or email ‘ applications (at) upsilonglobal . com’