At a Glance
- Tasks: Manage clinical trials from start to finish, ensuring compliance and efficiency.
- Company: Join a leading organisation in the life sciences sector.
- Benefits: Competitive salary, flexible working options, and opportunities for professional growth.
- Other info: Dynamic role with opportunities to collaborate and innovate in a fast-paced environment.
- Why this job: Make a real difference in healthcare by managing impactful clinical trials.
- Qualifications: Degree in life sciences preferred; experience in clinical trial processes is a plus.
The predicted salary is between 36000 - 60000 £ per year.
Key Accountabilities
- Manage external vendors and contract research organizations.
- Prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan and Laboratory Manual.
- Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source documents.
- Assist with protocol development and study report completion.
- Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols.
- Provide guidance, direction, and management to CRAs.
- Track patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in coordination of data management activities.
- Coordinate study supplies.
- Negotiate contracts with vendors of clinical trial services.
- Review Informed Consent Forms, CRFs, and study related materials.
- Plan and participate in investigator meetings.
- Assist and support data query process.
- Ensure trial master file is current and maintained.
- Collaborate in the management of external vendors and contract research organizations to ensure efficient execution of clinical trials.
Skills
- Oversee all aspects of clinical trials from initiation to closeout, ensuring timely completion within budget through effective project management.
- Identify and resolve issues that arise in a timely manner during trial execution to minimize delays and maintain study integrity, employing strong problem-solving abilities.
- Effectively manage multiple tasks, deadlines, and priorities in a complex clinical trial environment.
- Clearly convey information and expectations to cross-functional teams, investigators, and stakeholders.
Knowledge and Experience
- Good Clinical Practices (GCPs) and regulatory compliance (FDA and ICH guidelines).
- Experience in clinical trial documentation and processes (e.g., protocols, CRFs, monitoring plans).
- Experience of data management and query resolution in clinical trials.
- Overall knowledge of site management and monitoring procedures.
Education
- Degree in the life sciences field preferred.
Clinical Trial Manager - FSP employer: Parexel International
Contact Detail:
Parexel International Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Trial Manager - FSP
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical trial space, attend industry events, and join relevant online forums. We all know that sometimes it’s not just what you know, but who you know that can help you land that Clinical Trial Manager role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of Good Clinical Practices (GCPs) and regulatory compliance. We recommend practising common interview questions related to project management and problem-solving in clinical trials. Show them you’re the expert they need!
✨Tip Number 3
Don’t forget to showcase your experience with external vendors and contract research organisations. We suggest having specific examples ready to demonstrate how you’ve successfully managed these relationships in past roles. It’ll make you stand out as a candidate!
✨Tip Number 4
Apply through our website! We make it easy for you to find and apply for the Clinical Trial Manager position. Plus, it shows your genuine interest in joining our team. Let’s get you that job!
We think you need these skills to ace Clinical Trial Manager - FSP
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter to highlight your experience in managing clinical trials and working with external vendors. We want to see how your skills align with the key accountabilities listed in the job description.
Showcase Your Problem-Solving Skills: In your application, give examples of how you've identified and resolved issues during clinical trials. We love candidates who can demonstrate strong problem-solving abilities, so don’t hold back!
Highlight Relevant Experience: Be sure to mention any experience you have with Good Clinical Practices (GCPs) and regulatory compliance. We’re looking for someone who knows their stuff when it comes to clinical trial documentation and processes.
Apply Through Our Website: We encourage you to submit your application through our website. It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it’s super easy!
How to prepare for a job interview at Parexel International
✨Know Your GCPs Inside Out
Make sure you brush up on Good Clinical Practices (GCPs) and regulatory compliance before the interview. Being able to discuss how these guidelines impact clinical trials will show that you’re not just familiar with the theory, but you understand their practical application.
✨Showcase Your Project Management Skills
Prepare examples of how you've effectively managed multiple tasks and deadlines in previous roles. Use the STAR method (Situation, Task, Action, Result) to structure your responses, highlighting your problem-solving abilities and how you’ve kept projects on track.
✨Familiarise Yourself with Study Documentation
Get comfortable discussing key study documents like Monitoring Manuals and CRFs. Be ready to explain your experience with these documents and how you’ve contributed to their development or management in past roles.
✨Engage with Cross-Functional Teams
Think about times when you’ve worked with diverse teams or stakeholders. Be prepared to share how you communicated expectations clearly and resolved any conflicts, as this is crucial for a Clinical Trial Manager role.