kps life
Clinical Trial Manager UK/EU
Get notified of more jobs like this · No spam, ever
How your CV stacks up
Upload your CV to see how well it fits this job role
?%
Clinical Trial Manager (CTM)
KPS is looking for a CTM to join sponsor team. Fixed term contract, remote.
About the Role
The Clinical Trial Manager (CTM) is responsible for study team leadership in one or more cross functional study teams to deliver clinical research study deliverables on time, within budget and with good quality in compliance with Regulatory Authorities’ regulations/ICH GCP guidelines and applicable SOPs. This role collaborates and interacts with the Clinical Study Team and oversees the functional duties of the study and CRA team.
The CTM Will:
- Be responsible for the oversight of the execution and adherence of various aspects of the study operational plan (start up, conduct, close-out, and vendor oversight) with input from key stakeholders including adherence to all relevant regulations including GCP, ICH and Regulatory requirements, as well as applicable SOPs and policies.
- Be responsible for the oversight of monitoring assigned study operational plan.
- Be responsible for managing assigned as study budget, timelines, and risk mitigation process input from key stakeholders, communicating to the clinical team, as appropriate.
- Support the development and application of standardized operational study processes, methodologies, appropriate quality and performance metrics and tools to systematize continuous process improvement and impart best practices across clinical operations to maximize its effectiveness.
- Be responsible for the filings of all clinical trial documentation in eTMF and paper TMF as assigned.
Reasons to use Rodeo
Start with a chat, not a search bar
Grad scheme, placement, apprenticeship? Not sure what you want yet — that's fine. Your agent talks it through with you and turns "I have no idea" into a shortlist.
It searches the market for you
Every day your agent scans the market matching roles against what actually matters to you, not just keywords on a CV.
Only hits
No noise. No "maybe this fits." Just roles with a clear explanation of why they're right — and where to focus when applying.
The CTM Will Have:
- In-depth knowledge of clinical drug development processes and experience applying GCP, ICH and FDA requirements.
- Solid knowledge of clinical research study protocol and processes; ability to incorporate and adhere to GCP and regulatory standards. Ability to develop study processes in support of a clinical study design.
- Demonstrated solid knowledge in several areas related to clinical research: human anatomy, subject protection, regulatory requirements, study design, study execution.
- Demonstrated skills in implementing tools for effective study management, identifying and implementing solutions to address study issues, overcoming obstacles.
- Demonstrated skills in cultivating relationships with healthcare professionals and cross-functionally with co-workers from both the Sponsor and KPS teams.
- Demonstrated skills in maintaining composure and identifying and adapting to shifting priorities and competing demands.
- Excellent written and verbal communication.
- The ability to generate concise summaries for different audiences, professional correspondence, presentations, reports, and training materials.
- Literacy in word processing, spreadsheets, and databases applications (e.g., MS Word and Excel).
- Skilled at developing project timelines and milestones and working with team to ensure milestones are met; adjusts appropriately when needed and communicates risks when necessary.
- Ability to identify and articulate risks and benefits of plan.
- Strong communication skills to be able to discuss with the Principal and Sub-Investigators and their site staff, even in challenging situations such as recruitment, protocol deviations and oversight.
- High attention to detail and accuracy; ability to ensure data accuracy and review data.
Get help with your application
Your very own career expert that helps elevate your application to the next level.
The CTM Will Have:
- BS degree in biology, allied health, nursing or related life science preferred.
- 5 or more years related experience in clinical study execution.
- Experience leading a study or significant participation on study team through major milestones.
- Experience in planning study design for pre and/or post market trials.
- Experience managing others as direct supervisor and/or leader of matrix clinical trial team preferred.
- Experience managing CROs and other external providers.
- System experience preferred: (i.e. CTMS, eDC, eTMF etc.).
“It took my CV and asked me questions relevant to understanding what kind of jobs to suggest for me. Suggestions were almost perfect. Jobs were exactly what I’ve been looking for.”
Jessica, London
Location