What are the responsibilities and job description for the Associate Director, Clinical Data Management position at Cabaletta Bio?
About the Position
The Associate Director, Clinical Data Management will serve as a senior Data Management Lead and strategic data management leader across assigned clinical studies. This role will provide end-to-end leadership from protocol review and study start-up through database lock, regulatory submission support, long-term follow-up, and archival, while ensuring high-quality, analysis-ready clinical data.
Responsibilities Include
- Serve as senior Data Management Lead for assigned clinical studies across multiple phases, providing end-to-end leadership from protocol review through database lock, long-term follow-up, and archival.
- Review protocols and study strategies to ensure feasible, compliant, and effective data collection.
- Lead EDC, CRF, edit check, query logic, user requirements, and CRF completion guideline development.
- Oversee external data integrations, transfers, reconciliation, medical coding, and validation.
- Develop and maintain data management plans, database specifications, validation records, UAT documentation, and data review plans.
- Lead cross-functional data review and align stakeholders on quality, timelines, and risk mitigation.
- Oversee CROs and vendors, including selection, performance, quality, timelines, budgets, and change orders.
- Drive study and program milestones, proactively identifying risks and implementing solutions.
- Lead database testing, UAT, data cleaning, coding, reconciliation, database lock, and archival.
- Review data listings and support analyses, safety monitoring committees, endpoint adjudication, and submissions.
- Support regulatory submissions, health authority responses, inspection readiness, and audits.
- Ensure compliance with GCP, applicable FDA and ICH requirements, company procedures, industry standards, and applicable CDISC standards.
- Contribute to data standards, SOPs, technology assessments, and continuous process improvement.
- Provide leadership, mentoring, and technical guidance to data management staff.
- Represent Clinical Data Management on cross-functional teams and communicate status, risks, and resource needs.
Required Qualifications
- Bachelor's degree in life sciences, health sciences, or a related field.
- 10 years of progressive clinical data management experience within the pharmaceutical, biotechnology, or clinical research industry.
- Demonstrated experience serving as a senior Data Management Lead and providing end-to-end leadership for global Phase I-IV clinical studies.
- Experience leading clinical data management strategy across multiple studies or development programs.
- Extensive experience overseeing CROs and external vendors, including vendor selection, performance, quality, timelines, budgets, and change orders.
- Demonstrated experience with EDC design and implementation, CRF design, edit checks, query logic, UAT, database validation, data review, and database lock.
- Experience managing external data integrations, data transfers, reconciliation activities, and medical coding processes.
- Working knowledge of MedDRA and WHO Drug dictionaries and coding practices.
- Experience supporting regulatory submissions, health authority responses, inspection readiness activities, and audits.
- Strong knowledge of GCP, FDA, ICH, and other regulatory requirements applicable to clinical data capture and management.
- Working knowledge of CDISC standards, including SDTM and ADaM, and experience collaborating with Biostatistics and Statistical Programming.
- Experience developing and maintaining clinical data management plans, database specifications, validation documentation, CRF completion guidelines, and other study documentation.
- Experience reviewing protocols, statistical analysis plans, CRFs, clinical study reports, and related clinical trial documents.
- Demonstrated ability to lead cross-functional data review, manage complex timelines and risks, and deliver high-quality, analysis-ready clinical data.
- Experience mentoring data management staff and contributing to SOP development, training, technology assessment, and process improvement.
- Outstanding written, verbal, organizational, interpersonal, problem-solving, and leadership skills.
How to Apply
Please click the link at the bottom of the posting to submit an application.
Benefits
Our most important asset is our people and we offer competitive benefits including health and retirement, PTO, and stock option plans.
Equal Opportunity Employer
Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.