Director, Program Lead – Clinical Data Management

This is a fully remote position, open to applicants in United States, +6 more locations.

📋 Description

• Oversee program-level strategy and execution across various programs or therapeutic areas as the Global Clinical Data Management subject matter expert.

• Ensure consistency, quality, and resource allocation across programs.

• Maintain compliance with team standards, data quality expectations, and regulatory guidelines.

• Provide leadership and guidance to program teams; identify and address operational risks.

• Own the data management strategy and plans for programs and portfolios, including eCRF, labs, biomarkers, PRO/eCOA, imaging, and other data types.

• Lead planning based on risk assessment, timelines, and inter-study dependencies within complex portfolios.

• Ensure consistent data collection, integration, validation, user acceptance testing, database locking, and readiness for inspections across trials.

• Manage quality, risk assessment, root cause analysis/corrective and preventive actions, audits, inspections, documentation, and archival processes.

• spearhead strategic initiatives in data standards, automation, digital enablement, and quality frameworks.

• Represent Global Data Management & Standards in program- and portfolio-level discussions.

• Collaborate with Clinical, Biostatistics and Research Data Science, Data Integration and Automation, Safety, IT, service providers, Clinical Trial Operations, and Therapeutic Area leadership.

• Serve as the escalation point for intricate cross-functional and cross-program challenges.

• Support acquisitions and partnerships by overseeing data management due diligence and integration.

• Enhance organizational capability through mentoring, training, playbooks, and communities of practice.

• Create and utilize dashboards, KPIs, and analytics to steer execution oversight and service provider engagement.

• Oversee service provider performance, including service level agreements, KPIs, quarterly business reviews, escalations, and remediation planning.

• Establish objectives, delegate tasks, conduct performance reviews, coach team members, develop career trajectories, lead recruitment efforts, manage employee relations, coordinate resources, oversee budgets, facilitate meetings, and report to leadership.

⛳️ Requirements

• A Bachelor's degree or an equivalent educational background in Nursing, Pharmacy, Life Sciences, Allied Health, Data/Information Technology, or Medical Technology, combined with 10 years of experience in clinical data management, clinical trial operations, or a related field.

• A Bachelor's degree or an equivalent educational background in any other discipline, coupled with a minimum of 15 years of experience in data management, clinical trial operations, or a related field.

• An advanced degree (Master's or Doctorate) in specified fields with at least 8 years of experience (preferred).

• An advanced degree (Master's or Doctorate) in another field with a minimum of 13 years of experience.

• Extensive subject matter expertise and strong people management skills.

• Proven experience in leading geographically distributed cross-functional teams in clinical data management or clinical trial operations strategy, execution, and submissions.

• In-depth understanding of the clinical development lifecycle, end-to-end data flow, and cross-functional dependencies.

• Experience in managing end-to-end clinical trial data management, including database design and construction, user acceptance testing, data validation and reconciliation, and database locking.

• Experience in overseeing complex portfolios, resource models, and multi-program delivery.

• Proficient in clinical data management platforms, EDC, eCOA, query management, reconciliation and integration workflows, and data visualization/dashboarding tools.

• Knowledge of data structures and integrations across EDC and related systems, including labs, Interactive Response Technology (IRT), eCOA, and imaging.

• Advanced knowledge in CDISC, CDASH, SDTM, Define-XML, metadata management, controlled terminologies such as LOINC, and GDMS standards.

• Familiarity with data quality frameworks, standard operating procedures, ICH-GCP, 21 CFR Part 11/Annex 11, privacy regulations, and risk-based quality management principles.

• Expertise in operational metrics, analytics, and continuous improvement methodologies.

• Travel requirement: ≤10%

🏝️ Benefits

• Remote work arrangement available.

• Regular employee status.

• No relocation necessary.

• Visa sponsorship not required.

• Travel requirement up to 10%.

• Flexible work arrangements: Remote.