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Director, Clinical Data Management

The Steely Group

Lexington, MA

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JOB DETAILS
SKILLS
Acceptance Testing, Analysis Skills, Automation, Biology, Biotech and Pharmaceutical, Case Report Form (CRF), Clinical Data, Clinical Data Interchange Standards Consortium (CDISC), Clinical Data Management, Clinical Practices/Protocols, Clinical Trial, Communication Skills, Computer Science, Contract Analysis, Contract Research Organization (CRO), Cross-Functional, Data Analysis, Data Cleaning, Data Management, Data Processing, Data Quality, Database Administration, Database Report Tools, Electronic Data Capture (EDC), Electronic Design, FDA Requirements, GCP (Good Clinical Practices), Health Science, ICH Regulations, Industry Standards, Leadership, Mathematics, Medical Dictionary for Regulatory Activities (MedDRA), Metrics, Oncology, Organizational Skills, Outsourcing, Performance Analysis, Presentation/Verbal Skills, Problem Solving Skills, Process Improvement, Process Management, Python Programming/Scripting Language, Quality Control, Quality Metrics, R Programming Language, Reconciliation, Regulations, Regulatory Compliance, Regulatory Requirements, SQL (Structured Query Language), Software Validation, Standard Operating Procedures (SOP), Startup, Statistical Analysis System (SAS), Team Lead/Manager, Team Player, Training/Teaching, Validation Testing, Vendor/Supplier Selection, Writing Skills
LOCATION
Lexington, MA
POSTED
30+ days ago
The Director, Clinical Data Management (CDM) is responsible for oversight, execution, and quality of all data management activities across assigned clinical trials from study start-up through database lock. This role ensures the integrity, completeness, and regulatory compliance of clinical trial data while leading cross-functional collaboration, CRO oversight, and continuous process improvement.

The CDM provides both operational leadership and strong technical expertise across the full data lifecycle, maintaining the highest standards of data quality in accordance with regulations.

Responsibilities:
  • Serve as the data management lead on cross-functional study teams.
  • Oversee the collection, validation, reconciliation, and processing of clinical trial data from first patient through database lock.
  • Ensure synchronization of data management timelines with overall clinical study timelines.
  • Provide oversight of CROs and external service providers; monitor performance, deliverables, and quality metrics.
  • Participate in vendor selection and contract evaluation for outsourced data management activities.
  • Contribute to departmental initiatives, SOP development, process optimization, and technology enhancements.
  • Develop, review, and approve key study documents including data management plan, case report forms, database build specifications, data transfer specifications, SAE reconciliation plans
  • Design and oversee electronic Case Report Forms (eCRFs) and Electronic Data Capture (EDC) systems.
  • Oversee database build, migration, updates, validation testing, and User Acceptance Testing (UAT).
  • Develop and execute data validation checks and quality control procedures.
  • Lead routine data review and cleaning, discrepancy management, query generation/resolution
  • Generate and review data listings, summaries, metrics, and reports to support interim analyses and clinical study reports.
  • Provide training on EDC systems, CRF completion guidelines, and data management processes to internal and external stakeholders.
  • Contribute to a professional and collaborative working environment aligned with company values.

Requirements / Qualifications:
  • Bachelor’s degree in health sciences, life sciences, mathematics, computer science, or related scientific discipline. Oncology/solid tumor clinical trial experience is a plus.
  • ~5 years of progressive clinical data management experience in pharmaceutical, biotechnology, or CRO environments (depth of experience considered in lieu of minimum years).
  • Strong expertise in clinical trial processes, data management principles, and regulatory requirements.
  • Working knowledge of GCP, CDISC requirements, ICH and FDA regulations
  • Hands-on experience with web-based Electronic Data Capture (EDC) systems and clinical data management platforms.
  • Experience in writing SQL queries to extract, review, and validate clinical trial data.
  • Exposure to R and/or Python for data analysis, data review automation, or visualization.
  • Experience with industry-standard dictionaries (MedDRA, WHO Drug).
  • Familiarity with data analysis/reporting tools such as SAS, SQL, or similar systems.
  • Proven CRO/vendor oversight experience.
  • Excellent verbal and written communication skills.
  • Strong analytical, problem-solving, and organizational abilities.

Preferred Qualifications:
  • Advanced degree in a related field.
  • Experience contributing to or validating data management software tools.

About the Company

T

The Steely Group

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