Director Clinical Data Management

The Steely Group; Boston (MA); On-site; USD 100,000 - 140,000; Full time

Job summary

A leading clinical research organization is seeking a Director of Clinical Data Management to oversee all data management activities for clinical trials. This role ensures data integrity, compliance, and quality throughout the data lifecycle. Responsibilities include leading cross-functional teams, overseeing CRO performance, and managing the creation of key clinical documents. The ideal candidate has a degree in health sciences or a related field, approximately five years of experience, and strong expertise in clinical trial processes and data management principles.

Qualifications

• Bachelor’s degree in a relevant scientific discipline.
• Approximately 5 years of clinical data management experience.
• Strong expertise in data management principles and regulatory requirements.

Responsibilities

• Lead data management activities across clinical trials from start-up to database lock.
• Ensure compliance with regulatory standards and data integrity.
• Oversee performance and quality metrics of CROs.

Skills

Clinical trial processes

Data management principles

Regulatory requirements

SQL

GCP

Communication skills

Analytical skills

Education

Bachelor’s degree in health sciences, life sciences, mathematics, computer science, or related discipline

Tools

Electronic Data Capture (EDC) systems

SAS

R

Python

Job description

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.
• 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.