Associate Director, Clinical Data Management

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Act as the senior Data Management Lead for designated clinical studies spanning various phases, from protocol evaluation to database closure, long-term follow-ups, and archiving.

• Assess protocols and study approaches to ensure that data collection is feasible, compliant, and effective.

• Direct the development of EDC, CRF, edit checks, query logic, user requirements, and CRF completion guidelines.

• Supervise external data integrations, transfers, reconciliations, medical coding, and validation processes.

• Create and uphold data management plans, database specifications, validation documentation, UAT records, and data review strategies.

• Guide cross-functional data reviews and align stakeholders on quality standards, timelines, and risk mitigation strategies.

• Manage CROs and vendors, including their selection, performance assessment, quality control, timelines, budgets, and change orders.

• Propel study and program milestones, identify potential risks, and implement effective solutions.

• Lead database testing, UAT, data cleaning, coding, reconciliation, database closure, and archiving.

• Examine data listings and assist with analyses, safety monitoring committees, endpoint adjudication, and regulatory submissions.

• Facilitate regulatory submissions, health authority communications, inspection readiness, and audits.

• Ensure adherence to GCP, FDA, ICH regulations, company protocols, industry standards, and CDISC guidelines.

• Contribute to the development of data standards, SOPs, technology evaluations, and continuous improvement initiatives.

• Offer leadership, mentoring, and technical support to data management personnel.

• Represent Clinical Data Management on cross-functional teams, communicating status updates, risks, and resource requirements.

⛳️ Requirements

• Bachelor’s degree in life sciences, health sciences, or a related discipline.

• Over 10 years of progressive experience in clinical data management within the pharmaceutical, biotechnology, or clinical research industries.

• Proven experience as a senior Data Management Lead, offering comprehensive leadership for global Phase I-IV clinical studies.

• Demonstrated ability to lead clinical data management strategies across multiple studies or development programs.

• Extensive experience in overseeing CROs and external vendors, including their selection, performance, quality, timelines, budgets, and change orders.

• Proficient in EDC design and implementation, CRF design, edit checks, query logic, UAT, database validation, data review, and database closure.

• Experience managing external data integrations, data transfers, reconciliations, and medical coding tasks.

• Familiarity with MedDRA and WHO Drug dictionaries and their coding practices.

• Experience in supporting regulatory submissions, health authority communications, inspection readiness, and audits.

• Solid understanding of GCP, FDA, ICH, and other relevant regulatory requirements.

• Working knowledge of CDISC standards, such as SDTM and ADaM, and collaboration with Biostatistics and Statistical Programming.

• Experience in developing and maintaining clinical data management plans, database specifications, validation documentation, CRF completion guidelines, and other study documents.

• Capability to review protocols, statistical analysis plans, CRFs, clinical study reports, and related clinical trial documentation.

• Ability to lead cross-functional data reviews, manage complex timelines and risks, and deliver high-quality, analysis-ready clinical data.

• Experience in mentoring data management staff and contributing to the development of SOPs, training, technology assessments, and process improvements.

• Exceptional written, verbal, organizational, interpersonal, problem-solving, and leadership capabilities.

🏝️ Benefits

• Competitive benefits package.

• Paid Time Off (PTO).

• Stock option plans.

• Commitment to employee well-being and ongoing professional development.