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- Tasks: Lead global clinical trials from start-up to closeout, ensuring high-quality delivery.
- Company: KPS Life, a forward-thinking company in clinical research.
- Benefits: Competitive salary, diverse work environment, and opportunities for professional growth.
- Why this job: Make a real impact in healthcare by managing innovative clinical studies.
- Qualifications: Bachelor’s degree and 4+ years of clinical research experience required.
- Other info: 3 days in the office in Uxbridge; dynamic team with excellent career prospects.
The predicted salary is between 50000 - 65000 £ per year.
KPS Life is seeking a Clinical Study Associate Manager (CSAM) to support global clinical trials in partnership with the Clinical Study Lead, with responsibilities across study start-up, vendor/CRO oversight, site activation, and ongoing study execution. This is a great opportunity for a clinical operations professional with 4+ years of clinical research experience who wants to play a key role in delivering high-quality clinical trials from start-up through closeout. 3 days in the office Uxbridge is a must.
About the Role
The Clinical Study Associate Manager (CSAM) Service supports the Clinical Study Lead by taking responsibility for areas of clinical trial delivery. The Clinical Study Associate Manager works with the study team internally and externally with vendors such as CROs in feasibility, planning, initiation, maintenance and closeout of clinical projects according to GCP, ICH, CFR and our Client’s Standard Operating Procedures (SOPs) and ICH/GCP. This Service applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs); the balance of direct execution versus oversight of CROs deliverables will vary accordingly.
Responsibilities
- May lead/oversee the planning and management of a clinical study in an assigned region(s) in alignment with the global study plans and may contribute to global planning and management of the study.
- Contributes to risk assessment and helps identify risk mitigation strategies.
- Supports feasibility assessment to select relevant regions and countries.
- Oversees and provides input to the development of study specific documentation including but not limited to: case report form (CRF), data management plan, monitoring plan, monitoring oversight plan, etc.
- Reviews site level informed consents and other patient-facing study start-up materials.
- Oversees setting up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS) and Trial Master File (TMF).
- Contributes to investigator meeting preparation and execution.
- Oversees engagement, contracting and management of required vendors for the study.
- Oversees and provides input to study drug and clinical supplies forecasting, drug accountability and drug reconciliation.
- Provides regular status reports to stakeholders as requested by the Clinical Study Lead.
- Contributes to development of and oversees implementation of recruitment and retention strategies.
- Monitors progress for site activation and monitoring visits.
- Supports data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations and suspected non-compliance by sites.
- Escalates data flow and data quality issues to Clinical Study Lead.
- Oversees the execution of the specific clinical study deliverables against planned timelines.
- Escalates issues related to timelines or budget to Clinical Study Lead.
- Supports accurate budget management and scope changes.
- Contributes to clinical project audit and inspection readiness throughout the study lifecycle.
- Supports internal and external inspection activities and contributes to CAPAs as required.
- Manages aspects of study close-out activities including but not limited to database lock, reconciliation of vendor contract, study budget, TMF and study drug accountability.
- May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring.
Qualifications
- Bachelor’s degree and minimum 4 years of relevant experience.
- Technical proficiency in trial management systems and MS applications, including but not limited to Teams, MS Office, Project, CTMS, EDC, IWRS/IVRS.
- Knowledge of ICH GCP and relevant regulatory guidelines/directives.
- Demonstrated interpersonal & leadership skills.
- Attention to details for the ability to deliver on specific study activities.
- Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritisation.
- Budget awareness with the ability to participate in various aspects of budget management.
- Effective communication skills via verbal, written and presentation abilities.
Equal Opportunity Statement
KPS Life is committed to diversity and inclusivity in the workplace.
Hybrid CSAM: Lead Clinical Trials from Start-up to Closeout in Uxbridge employer: KPS Life
Contact Detail:
KPS Life Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Hybrid CSAM: Lead Clinical Trials from Start-up to Closeout in Uxbridge
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical research field and let them know you're on the hunt for a CSAM role. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ICH GCP and relevant regulatory guidelines. Be ready to discuss how your experience aligns with the responsibilities of overseeing clinical trials from start-up to closeout.
✨Tip Number 3
Showcase your leadership skills during interviews. Talk about times you've successfully managed teams or projects, especially in clinical settings. This will demonstrate that you’re not just a team player but also someone who can take charge when needed.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in joining our team at KPS Life.
We think you need these skills to ace Hybrid CSAM: Lead Clinical Trials from Start-up to Closeout in Uxbridge
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the role of Clinical Study Associate Manager. Highlight your relevant experience in clinical trials, especially any leadership roles you've had. We want to see how your background aligns with the responsibilities listed in the job description.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about clinical research and how your skills make you a perfect fit for KPS Life. Don’t forget to mention specific experiences that relate to the job requirements.
Showcase Your Technical Skills: Since technical proficiency is key for this role, be sure to highlight your experience with trial management systems and MS applications. We want to know how comfortable you are with tools like CTMS and EDC, so don’t hold back!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it shows us you’re serious about joining our team at KPS Life!
How to prepare for a job interview at KPS Life
✨Know Your Clinical Trials Inside Out
Make sure you brush up on your knowledge of clinical trial processes, especially the phases from start-up to closeout. Familiarise yourself with GCP, ICH guidelines, and any specific regulations that KPS Life adheres to. This will show that you're not just interested in the role but also understand the intricacies involved.
✨Showcase Your Leadership Skills
As a CSAM, you'll be expected to lead and oversee various aspects of clinical trials. Prepare examples from your past experiences where you've successfully led a team or project. Highlight your interpersonal skills and how you've managed vendor relationships or CRO oversight effectively.
✨Be Ready for Scenario-Based Questions
Expect questions that put you in hypothetical situations related to risk assessment, site activation, or budget management. Think through your approach to these scenarios beforehand, and be ready to discuss your thought process and decision-making strategies.
✨Prepare Questions for Them
Interviews are a two-way street! Prepare insightful questions about KPS Life's current projects, their approach to clinical trial management, or how they foster diversity and inclusivity in the workplace. This shows your genuine interest in the company and helps you assess if it's the right fit for you.