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- Tasks: Lead and manage clinical trials from start to finish, ensuring compliance and quality.
- Company: Join a dynamic midsized pharma company focused on oncology innovations.
- Benefits: Enjoy competitive pay, professional growth opportunities, and a collaborative work environment.
- Why this job: Make a real impact in cancer research while working with top professionals in the field.
- Qualifications: 5+ years in clinical operations; strong GCP and ICH knowledge required.
- Other info: Opportunity to work across LATAM and engage with diverse teams.
The predicted salary is between 48000 - 72000 £ per year.
Senior Clinical Trial Manager looking after LATAM
Oncology-focused Midsized Pharma Company
The role will focus on vendor management and site engagement in LATAM for the Phase III global clinical trial.
Summary
The Senior Clinical Trial Manager oversees clinical trial sites from start-up to close-out, ensuring compliance with the study protocol, ICH guidelines, Good Clinical Practices (GCP), and regulatory requirements. They collaborate with the Clinical Project Manager (CPM), CRO representatives, and vendors to manage clinical studies effectively. Additionally, they may supervise Clinical Trial Managers to ensure deliverables are met on time, within budget, and to quality standards.
- Participate in the planning, implementing, and managing clinical trials in compliance with industry regulations and ICH-GCP. – Oversee CROs and clinical trial sites, ensuring timely delivery, meeting recruitment targets, and producing high-quality data.
- Track site visit metrics, data quality concerns, and protocol deviations; conduct oversight visits for compliance evaluation. – Assist in initiation visits to confirm site training and foster relationships among sponsors, CROs, and investigators.
- Review CRA monitoring reports to ensure protocol and operational compliance; escalate issues for resolution.
- Collaborate with teams for efficient study start-up, identifying risks and ensuring timelines are met.
- Act as a subject matter expert on assigned protocols and manage CRO/site during start-up activities, including contract negotiations and document collection.
- Could you provide direction to ensure consistency in Clinical Operations processes across trials and regions?
- Work cross-functionally with departments to meet study requirements and timelines.
- Contribute to developing and reviewing study-related documents and deliver trial-specific training.
- Monitor open action items and data trends, addressing issues with CROs to enhance study execution and efficiency.
- Develop and oversee patient recruitment and retention strategies, acting on any deviations from the plan.
Experience
- Minimum of 5 years of clinical operational experience in biotechnology, pharmaceuticals, and/or CROs.
- Strong understanding of GCP, ICH, GDP, relevant CFRs; familiarity with MHRA, EMA, and international regulations is a plus.
- Experience with clinical trial site start-up and initiation.
- Proven ability to build and maintain relationships with clinical trial sites and Principal Investigators.
- Strong communication skills for coordinating activities with internal teams, sites, and vendors.
- Proactive in identifying project challenges and proposing corrective actions with minimal supervision.
- Capable of working independently and delivering high-level presentations.
- Knowledge and experience in oncology.
- Previous experience as a Clinical Research Associate (CRA).
Sr Clinical Trial Manager employer: Advanced Clinical
Contact Detail:
Advanced Clinical Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Sr Clinical Trial Manager
✨Tip Number 1
Make sure to highlight your experience in vendor management and site engagement, especially in the LATAM region. This role emphasizes collaboration with CROs and clinical trial sites, so showcasing any relevant experience will set you apart.
✨Tip Number 2
Demonstrate your understanding of GCP, ICH guidelines, and regulatory requirements through specific examples from your past roles. This will show that you are well-versed in compliance, which is crucial for this position.
✨Tip Number 3
Emphasize your ability to build and maintain relationships with clinical trial sites and Principal Investigators. Providing examples of successful collaborations can illustrate your interpersonal skills and effectiveness in managing stakeholder relationships.
✨Tip Number 4
Since the role requires proactive problem-solving, be prepared to discuss specific challenges you've faced in previous clinical trials and how you addressed them. This will demonstrate your capability to handle project challenges independently.
We think you need these skills to ace Sr Clinical Trial Manager
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Senior Clinical Trial Manager position. Highlight key responsibilities and required skills, such as vendor management, site engagement, and compliance with GCP and ICH guidelines.
Tailor Your CV: Customize your CV to reflect your relevant experience in clinical operations, particularly in oncology and managing clinical trials. Emphasize your understanding of regulatory requirements and your ability to build relationships with trial sites.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for clinical research and your specific experiences that align with the job. Mention your proactive approach to problem-solving and your ability to work independently while delivering high-quality results.
Highlight Relevant Experience: In your application, be sure to detail your previous roles, especially any experience as a Clinical Research Associate (CRA) or in managing clinical trial sites. Use specific examples to demonstrate your expertise in overseeing trial processes and ensuring compliance.
How to prepare for a job interview at Advanced Clinical
✨Show Your Expertise in Oncology
Make sure to highlight your knowledge and experience in oncology during the interview. Discuss specific trials you've managed or participated in, and how your expertise can contribute to the company's goals.
✨Demonstrate Vendor Management Skills
Prepare examples of how you've successfully managed vendors and CROs in past roles. Be ready to discuss challenges you faced and how you overcame them to ensure compliance and quality in clinical trials.
✨Emphasize Communication Abilities
Strong communication is key in this role. Share instances where your communication skills helped resolve issues or improved collaboration among teams, sites, and vendors. This will show your ability to coordinate effectively.
✨Be Proactive About Challenges
Discuss your proactive approach to identifying project challenges and implementing corrective actions. Prepare to share specific examples where your foresight led to successful outcomes in clinical trial management.
