Senior Director, Data Management

Bicycle Therapeutics; Cambridge; On-site; GBP 90,000 - 120,000; Full time

Job summary

A biotech company located in Cambridge is looking for a Head of Clinical Data Management. The role involves leading the clinical data management strategy for oncology trials and ensures the integrity and compliance of clinical data. The ideal candidate should possess extensive experience in clinical data management and oncology trials, strong leadership skills, and expertise in EDC systems. Comprehensive benefits are provided including flexible working, private medical insurance, and an annual bonus.

Benefits

Flexible working environment

Private Medical Insurance

Competitive annual bonus

Employer pension contribution

Gym membership subsidy

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.

Responsibilities

• Develop and execute a comprehensive strategy for clinical data management.
• Oversee the entire lifecycle of clinical data management for all trials.
• Ensure all data management activities comply with global regulatory requirements.

Skills

Leadership

Data Management

Communication

Strategic Thinking

Problem-Solving

Education

Experience in clinical data management

Experience in oncology clinical trials (I-IV)

Tools

EDC systems (Medidata Rave, Veeva)

CDISC standards

Job description

Job Description

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.

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

• 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

Competencies, Culture and Behaviour at Bicycle

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:

• 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.
• Task / Project Delivery: Oversees a portfolio of programsbalancing ambition with resources.
• Problem-Solving: Resolves organization-wide challenges with innovative solutions.
• Strategic Impact: Contributes directly to organizational strategy and direction.

Values & Behaviors 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: 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.

Dedicated to our mission:

• Innovation: Champions adoption of emerging technologies and practices.
• Risk-Taking: Takes calculated risks to position organisation for success.
• Change Leadership: Leads confidently through major organisational transformations.

Additional Information

• State-of-the-art campus environmentwith on campus restaurant and Montessori nursery
• Flexible working environment
• Competitive reward including annual company bonus
• 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

We are committed to building a diverse workforce and do not discriminate on the basis of race, religion, colour, gender, sexual orientation, age, disability status, marital status, or veteran status.