Associate Director, Clinical Data Management
Generate Biomedicines
Summary
The Associate Director, Clinical Data Management will serve as the lead data manager for one or more clinical programs, providing strategic and operational oversight of study-level data management activities from study start-up through database lock. This role is ideal for an experienced hands-on data management professional who enjoys partnering closely with cross-functional teams and CROs to ensure the delivery of high-quality clinical data.
Job description
The Role
The Associate Director, Clinical Data Management will serve as the lead data manager for one or more clinical programs, providing strategic and operational oversight of study-level data management activities from study start-up through database lock. This role is ideal for an experienced hands-on data management professional who enjoys partnering closely with cross-functional teams and CROs to ensure the delivery of high-quality clinical data.
The successful candidate will be responsible for study execution, vendor oversight, risk identification, and data quality management while serving as the primary data management representative for assigned clinical studies.
Study-Level Data Management Leadership
- Serve as the lead data manager for assigned phase 3 clinical studies and programs.
- Develop and maintain study-specific data management strategies, timelines, and deliverables.
- Provide oversight of CRO and vendor data management activities to ensure quality, compliance, and adherence to timelines.
- Review and approve key data management documents, including Data Management Plans (DMPs), Data Validation Plans (DVPs), edit check specifications, eCRF specifications, and database build documentation.
- Lead data review, query management, reconciliation, and database lock activities.
Study Oversight & Cross-Functional Collaboration
- Partner with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Pharmacovigilance, and external vendors throughout study conduct.
- Monitor data quality and study metrics to proactively identify risks and drive issue resolution.
- Support external data integrations and reconciliation activities.
- Participate in study team meetings and provide regular updates on data management activities, risks, and timelines.
- Contribute to inspection readiness and ensure compliance with GCP and applicable regulatory requirements.
Vendor Management
- Act as the primary point of contact for CRO and vendor data management activities.
- Review vendor deliverables and ensure study requirements are met.
- Escalate study risks, issues, and timeline concerns as appropriate.
- Drive accountability for study-level data management deliverables.
Process Improvement
- Contribute to the development and improvement of data management processes and standards.
- Share best practices and lessons learned across studies.
- Support initiatives to improve data quality, efficiency, and study execution.
Key Competencies
- Strong study execution and project management skills.
- Excellent communication and stakeholder management abilities.
- Ability to influence without direct authority.
- Proactive problem-solving and risk management mindset.
- Detail-oriented with a focus on data quality and operational excellence.
- Comfortable working independently in a fast-paced biotech environment.
Requirements
- Bachelor's degree in Life Sciences, Health Sciences, Computer Science, or a related discipline
- Minimum of 10+ years of clinical data management experience within the pharmaceutical, biotechnology, or CRO industry
- Experience serving as a lead data manager for Phase 2 and/or Phase 3 clinical trials
- Strong hands-on experience with Medidata Rave EDC
- Experience managing CRO and vendor deliverables
- Solid understanding of database design, edit checks, data review, query management, and reconciliation activities
- Strong knowledge of ICH-GCP and applicable regulatory requirements
- Excellent written, verbal, and interpersonal communication skills
- Strong organizational skills with the ability to manage multiple priorities and timelines
- Experience in COPD, respiratory, pulmonary, or related therapeutic areas
- Experience working in a small to mid-sized biotechnology company environment
- Experience supporting global Phase 3 clinical studies
- Familiarity with CDISC standards and risk-based data review methodologies
- Experience with external vendor data integrations and reconciliations
Benefits
- Annual Bonus
- Equity Compensation
- Competitive Benefits Package
Company overview
Generate Biomedicines is a pioneering therapeutics company operating at the intersection of machine learning, biological engineering, and medicine. The company is revolutionizing drug discovery through its proprietary Generative Biology™ platform, which enables the on-demand generation of novel protein-based medicines across multiple therapeutic modalities. By studying millions of proteins to understand nature's functional encoding rules, Generate Biomedicines can design and create breakthrough medicines with unprecedented speed and success rates. The company's platform represents a fundamental shift in therapeutic development, moving beyond traditional discovery methods to programmed generation of biologics including antibodies, peptides, enzymes, and stealth proteins. With advanced AI algorithms and automated experimentation systems, Generate Biomedicines is advancing a pipeline of innovative therapies, including GB-0895 for severe asthma which is progressing to Phase 3 studies. As a Flagship Pioneering company, Generate Biomedicines combines cutting-edge computational biology with deep biological expertise to address humanity's most challenging diseases.