Senior Director, Clinical Data Management

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 companys 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.

Operational Management:

• 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.

Data Integrity & Compliance:

• 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.

Cross-Functional Collaboration:

• 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.

Qualifications :

Qualifications

• 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

Key Competencies & Skills

As a Senior Director at Bicycle we will be looking to assess the following competencies for the role during your application and interview process:  

Knowledge & Expertise:

• • Core Expertise: You guide the professional strategy for data management across multiple functions shaping the companys long-term approach to clinical data.
  • Data / Insight: You provide foresight and strategic interpretation of complex industry trends and data system capabilities to guide our long-term technology and data strategy.
  • Knowledge Sharing: You act as a thought leader representing Bicycles data strategy internally and externally to enhance our scientific and operational reputation.

Job Complexity:

• • Task / Project Delivery: You oversee the entire portfolio of data management activities ensuring the successful delivery of clean reliable data for all clinical programs.
  • Problem-Solving: You solve systemic organisation-wide challenges such as designing a next-generation clinical data warehouse or creating a strategy for integrating novel data sources.
  • Strategic Impact: You contribute directly to the R&D and corporate strategy by ensuring a cutting-edge well-executed data management approach is embedded across our pipeline.

Independence:

• • Autonomy: You independently shape the cross-functional direction for clinical data management partnering with senior leaders in IT and Clinical to drive our data vision.
  • Decision-Making: You make enterprise-level decisions regarding data systems vendors and strategic priorities that have organisation-wide implications.
  • Leadership / Mentorship: You develop future leaders within your function coaching senior data managers and ensuring robust succession planning.

Values & Behaviours at Bicycle.

We are driven by our mission and our culture is key to our success at Bicycle. Our employees embrace and roll model our values and at Senior Director level we would expect you to show:

One Team

• Collaboration: You create alignment across multiple teams and functions ensuring the data management function is a strategic partner to clinical development research and other key areas.
• Inclusive Leadership: You embed inclusivity and collaboration into the organisational culture fostering a data-driven environment where diverse ideas on data handling and technology are valued.
• Mentorship / Support: You coach senior leaders and data management experts actively engaging in succession planning to build our future leadership pipeline in data excellence.

Adventurous

• Innovation: You champion the adoption of emerging data technologies and practices driving the transformation of how we collect manage and leverage clinical data.
• Risk-Taking: You take calculated risks to position the organisation for success such as investing in new data platforms or methodologies to enhance efficiency and insight.
• Change Leadership: You lead the organisation confidently through major data system implementations process overhauls and other technological transformations.

Dedicated to our Mission

• Accountability: You ensure organisational priorities for data integrity quality and governance remain directly aligned with our mission to deliver robust and reliable clinical trial results.
• Resilience: You sustain focus and determination during high-stakes challenges such as database locks complex data migrations or regulatory inspections.
• Inspiration: You inspire organisation-wide commitment to data quality and excellence articulating a compelling vision that connects this work directly to patient safety and successful drug development.

Additional Information :

• State-of-the-art campus environment with on campus restaurant and Montessori nursery
• Flexible working environment
• Competitive reward including annual company bonus 
• Employee recognition schemes
• 28 days annual leave in addition to bank holidays  option to buy up to 5 additional days annually
• Employer contribution to pension (employee does not have to contribute) 
• Life assurance cover 4x basic salary 
• Private Medical Insurance including optical and dental cover 
• Enhanced parental leave policies
• Group income protection
• Employee assistance program
• Health Cash Plan
• Access to company subsidized gym membership
• Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc. 
• Cycle to work scheme 

Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve. We recognize that diverse and inclusive teams build a stronger and more innovative company. Therefore all qualified applicants will be considered for employment and we do not discriminate on the basis of race religion colour gender sexual orientation age disability status marital status or veteran status.

Remote Work :

No

Employment Type :

Full-time