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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; oncology experience preferred.
- 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. Being able to discuss how you've ensured compliance in past roles can show that you're a strong fit for overseeing clinical trials effectively.
✨Tip Number 3
Emphasize your ability to build relationships with Principal Investigators and clinical trial sites. Providing examples of how you've successfully fostered these relationships in previous positions can illustrate your capability in this area.
✨Tip Number 4
Be prepared to discuss your proactive approach to identifying project challenges and proposing solutions. This role requires a high level of independence, so sharing specific instances where you've navigated challenges will demonstrate your readiness for the position.
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. Understand the key responsibilities, required skills, and qualifications to tailor your application accordingly.
Highlight Relevant Experience: In your CV and cover letter, emphasize your clinical operational experience, particularly in oncology and with CROs. Provide specific examples of how you've managed clinical trials, vendor relationships, and compliance with GCP and ICH guidelines.
Showcase Communication Skills: Since strong communication skills are essential for this role, include examples of how you've effectively coordinated with internal teams, sites, and vendors. Highlight any presentations or training sessions you've conducted.
Tailor Your Cover Letter: Craft a personalized cover letter that addresses the specific requirements of the job. Mention your proactive approach to identifying project challenges and your ability to work independently, as these traits are crucial for success in this position.
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 previous 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 coordinate activities between internal teams, sites, and vendors effectively. This will show your ability to foster relationships and ensure smooth operations.
✨Be Proactive About Problem-Solving
Prepare to discuss how you've identified project challenges in the past and the corrective actions you proposed. This will demonstrate your proactive approach and ability to work independently, which are crucial for a Senior Clinical Trial Manager.
