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- Tasks: Lead clinical data management for oncology trials, ensuring data integrity and timely delivery.
- Company: Join a pioneering biotech firm dedicated to transforming cancer treatment.
- Benefits: Flexible working, competitive salary, annual bonus, and 28 days leave.
- Why this job: Make a real impact in oncology while leading innovative data management strategies.
- Qualifications: Extensive experience in clinical data management and oncology trials required.
- Other info: Dynamic work environment with opportunities for mentorship and career growth.
The predicted salary is between 72000 - 108000 £ per year.
The Head of Clinical Data Management is a strategic leadership role responsible for ensuring the integrity, quality, and timely delivery of all clinical trial data across our oncology portfolio. This individual will provide expert leadership and direction for data management activities, from study start-up through to database lock and regulatory submission.
This role is accountable for the development and implementation of a robust data management strategy, including the oversight of internal teams and external vendors (CROs). The ideal candidate will combine deep technical expertise in modern data management systems with a thorough understanding of the complexities of oncology clinical trials.
Strategic & Leadership:- Develop and execute a comprehensive, forward-thinking strategy for clinical data management that aligns with the company's goals.
- Lead, mentor, and build a high-performing clinical data management team.
- Drive the selection and implementation of advanced data management technologies and systems (e.g., EDC, ePRO) to enhance efficiency and quality.
- Establish and maintain departmental SOPs, work instructions, and data standards to ensure adherence to best practices and regulatory requirements.
- Oversee the entire lifecycle of clinical data management for all trials, ensuring deliverables are met on time and within budget.
- Lead the data management aspects of CRO and vendor selection, including proposal review and bid defense.
- Provide rigorous oversight of CROs and other data vendors, ensuring quality and performance standards are met.
- Manage the design and validation of clinical databases and Case Report Forms (eCRFs), ensuring they align with protocols and CDISC standards.
- Ensure all data management activities are conducted in compliance with GCP, GCDMP, 21 CFR Part 11, and other global regulatory requirements.
- Develop and oversee data validation plans, data cleaning procedures, and discrepancy management to ensure the highest data quality.
- Oversee medical coding activities (e.g., MedDRA, WHODrug).
- Ensure all clinical data is consistently maintained in an audit-ready state and support regulatory inspections as needed.
- Serve as the primary data management liaison, fostering strong partnerships with Clinical Operations, Biostatistics, Pharmacovigilance, and Regulatory Affairs.
- Collaborate with clinical and research teams to address the unique data requirements of oncology trials, including biomarkers, genomics, and imaging data.
- Demonstrable progressive experience in clinical data management within the pharmaceutical or biotechnology industry.
- Extensive experience in oncology clinical trials across all phases (I-IV) is required.
- Proven track record of successfully leading data management functions and teams.
- Significant experience in overseeing and managing CROs and other external data vendors.
- Experience with NDA, BLA, or other regulatory submissions is highly desirable.
- Expert knowledge of EDC systems (e.g., Medidata Rave, Veeva) and other clinical data technologies.
- Comprehensive knowledge of international regulatory requirements and guidelines (e.g., FDA, EMA, ICH/GCP).
- Exceptional leadership, communication, and project management skills.
- Demonstrated ability to think strategically while maintaining a strong attention to detail.
- Knowledge: Core Expertise: Guides scientific or professional strategy across multiple functions.
- Data / Insight: Provides foresight and strategic interpretation of complex data.
- Job Complexity: Task / Project Delivery: Oversees a portfolio of programs balancing ambition with resources.
- Problem-Solving: Resolves organization-wide challenges with innovative solutions.
- Strategic Impact: Contributes directly to organizational strategy and direction.
- One Team: Collaboration: Creates alignment across multiple teams and functions.
- Inclusive Leadership: Embeds inclusivity and collaboration in culture.
- Mentorship / Support: Coaches senior leaders and ensures succession planning.
- Adventurous: Innovation: Champions adoption of emerging technologies and practices.
- Risk-Taking: Takes calculated risks to position organization for success.
- Change Leadership: Leads confidently through major organizational transformations.
- State-of-the-art campus environment with on-campus restaurant and Montessori nursery.
- Flexible working environment.
- Competitive reward including annual company bonus.
- 28 days annual leave in addition to public holidays.
Senior Director, Data Management in Cambridge employer: Bicycle Therapeutics
Contact Detail:
Bicycle Therapeutics Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Director, Data Management in Cambridge
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, especially those who work in oncology or data management. A friendly chat can lead to insider info about job openings that aren't even advertised yet.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their mission and values, and think about how your experience aligns with their goals. This will help you stand out as a candidate who truly gets what they're about.
✨Tip Number 3
Showcase your leadership skills during interviews. Be ready to discuss specific examples of how you've built and mentored teams in the past. Companies love candidates who can inspire and drive their teams to success!
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Senior Director, Data Management in Cambridge
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter to highlight your experience in clinical data management, especially in oncology trials. We want to see how your skills align with our needs, so don’t hold back on showcasing your relevant achievements!
Showcase Your Leadership Skills: As a Senior Director, we’re looking for someone who can lead and mentor a team. Use your application to demonstrate your leadership style and any successful projects you've managed. Share specific examples that illustrate your ability to drive results.
Highlight Technical Expertise: We value deep technical knowledge in data management systems. Be sure to mention your experience with EDC systems and any other relevant technologies. This will help us understand how you can contribute to enhancing our data management 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 shows you’re keen on joining our team at StudySmarter!
How to prepare for a job interview at Bicycle Therapeutics
✨Know Your Data Management Inside Out
Make sure you brush up on your knowledge of clinical data management systems, especially EDC platforms like Medidata Rave and Veeva. Be ready to discuss how you've successfully implemented these technologies in past roles, particularly in oncology trials.
✨Showcase Your Leadership Skills
Prepare examples that highlight your experience in leading and mentoring teams. Think about specific instances where you built high-performing teams or drove strategic initiatives that aligned with company goals. This will demonstrate your capability to lead at a senior level.
✨Understand Regulatory Requirements
Familiarise yourself with GCP, GCDMP, and 21 CFR Part 11 regulations. Be prepared to discuss how you've ensured compliance in previous roles, as this is crucial for the position. Showing that you can maintain an audit-ready state will set you apart.
✨Emphasise Cross-Functional Collaboration
Think of examples where you've successfully collaborated with other departments like Clinical Operations or Biostatistics. Highlight how you addressed unique data requirements in oncology trials, as this role requires strong partnerships across various functions.
