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- Tasks: Lead global clinical trials, manage teams, and ensure high-quality deliverables.
- Company: Summit Therapeutics is pioneering innovative therapies in oncology with a focus on patient impact.
- Benefits: Enjoy a dynamic work environment with opportunities for growth and international travel.
- Why this job: Join a cutting-edge company making strides in cancer treatment and be part of impactful research.
- Qualifications: Bachelor's degree and 5 years of clinical project management experience required.
- Other info: Willingness to travel internationally up to 20% is essential.
The predicted salary is between 36000 - 60000 £ per year.
Summit has initiated clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials:
- HARMONi: Evaluates ivonescimab with chemotherapy versus placebo plus chemotherapy in EGFR-mutated, locally advanced or metastatic non-squamous NSCLC after 3rd generation EGFR TKI treatment.
- HARMONi-3: Compares ivonescimab with chemotherapy to pembrolizumab with chemotherapy as first-line treatment in metastatic NSCLC.
- HARMONi-7: Assesses ivonescimab monotherapy versus pembrolizumab monotherapy in first-line metastatic NSCLC with high PD-L1 expression.
Overview of Role:
The Clinical Trial Manager oversees all aspects of global clinical trial management, from start-up to closeout. This role involves leading cross-functional teams, managing CROs and vendors, and ensuring high-quality deliverables and performance metrics.
Role and Responsibilities:
- Manage study scope, quality, timelines, and budget with internal teams, CROs, and vendors.
- Build relationships with key opinion leaders and clinical site staff.
- Develop and execute patient enrollment and data monitoring strategies with CROs.
- Identify and mitigate study-related risks.
- Develop and oversee clinical trial documents and plans.
- Review and manage CRO and vendor contracts and specifications.
- Ensure timely site activation and review study reports.
- Monitor investigator performance and study conduct issues.
- Maintain and audit the Trial Master File (TMF).
- Ensure compliance with GCP, regulatory requirements, and company SOPs.
- Coach and oversee Clinical Trial Associates.
- Perform other duties as assigned.
Experience, Education, and Skills:
- Bachelor's degree or equivalent in life sciences or related fields.
- Minimum 5 years of clinical project management experience in international pharmaceutical or biotech trials, including phase II and III.
- Strong understanding of drug development, ICH/GCP guidelines.
- Experience with oncology clinical studies, budget management, and working with CROs.
- Willingness to travel internationally (up to 20%).
- Proven leadership, relationship-building, and communication skills.
- Ability to manage complex studies and collaborate across teams.
Clinical Trial Manager employer: Summit Therapeutics Sub, Inc.
Contact Detail:
Summit Therapeutics Sub, Inc. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Trial Manager
✨Tip Number 1
Familiarise yourself with the latest developments in oncology, particularly related to non-small cell lung cancer (NSCLC). Understanding the specifics of ivonescimab and its clinical trials will help you engage in meaningful conversations during interviews.
✨Tip Number 2
Network with professionals in the clinical trial management field. Attend industry conferences or webinars where you can meet people who work at Summit Therapeutics or similar companies. Building these connections can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss your experience with managing CROs and vendors. Be ready to share specific examples of how you've successfully navigated challenges in previous projects, as this will demonstrate your capability to handle the responsibilities outlined in the job description.
✨Tip Number 4
Showcase your leadership skills by preparing examples of how you've built relationships with key opinion leaders and clinical site staff. Highlighting your ability to foster collaboration will be crucial, as this is a key aspect of the Clinical Trial Manager role.
We think you need these skills to ace Clinical Trial Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in clinical project management, especially in international pharmaceutical or biotech trials. Emphasise your understanding of ICH/GCP guidelines and any specific oncology study experience.
Craft a Compelling Cover Letter: Write a cover letter that showcases your leadership skills and ability to manage complex studies. Mention your experience with CROs and your strategies for patient enrollment and data monitoring, as these are key aspects of the role.
Highlight Relevant Skills: In your application, clearly outline your skills in budget management, risk identification, and compliance with regulatory requirements. These are crucial for the Clinical Trial Manager position and will set you apart from other candidates.
Proofread Your Application: Before submitting, thoroughly proofread your application materials. Ensure there are no typos or grammatical errors, as attention to detail is vital in clinical trial management.
How to prepare for a job interview at Summit Therapeutics Sub, Inc.
✨Know Your Clinical Trials
Familiarise yourself with the specifics of the clinical trials mentioned in the job description, especially those related to ivonescimab. Understanding the phases and objectives of these trials will demonstrate your genuine interest and expertise in the field.
✨Showcase Your Leadership Skills
As a Clinical Trial Manager, you'll need to lead cross-functional teams. Prepare examples from your past experiences where you successfully managed teams or projects, highlighting your leadership style and how you resolved conflicts or challenges.
✨Understand Regulatory Requirements
Brush up on GCP and ICH guidelines, as well as any relevant regulatory requirements. Being able to discuss these in detail will show that you are well-prepared and knowledgeable about compliance, which is crucial for this role.
✨Prepare Questions for Them
Have insightful questions ready to ask the interviewers about their ongoing projects, team dynamics, or company culture. This not only shows your enthusiasm but also helps you assess if the company aligns with your career goals.
