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 : Essential
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 detailCompetencies 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.Independence :
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.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 :
Flexible working environmentCompetitive reward including annual company bonusMedical dental and vision insurance for eligible employees and their families with 100% of the premiums covered by the CompanyHealth and Dependent Care Flexible Spending Accounts401(k) plan with a 4% Company match and immediate vestingEligibility to accrue up to 23 paid time off days per full year worked plus the option to buy up to 5 additional daysEmployee assistance programEmployee recognition schemes10 Company holidaysCompetitive Family Leave PolicyEligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.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
Key Skills
Category Management,Athletics,Customer,ABAP,Hydraulics,ITI
Experience : years
Vacancy : 1