Key Responsibilities and Required Skills for Lead Clinical Data Manager

🎯 Role Definition

This is a pivotal, hands-on leadership role where you will spearhead all clinical data management activities for our innovative clinical trials. As the Lead Clinical Data Manager, you will be the central point of contact for all data-related aspects of your assigned studies, ensuring the highest standards of data quality, integrity, and timeliness. You will not only manage projects and vendors but also mentor junior data managers, drive process improvements, and collaborate extensively with cross-functional teams including Clinical Operations, Biostatistics, and Regulatory Affairs. Your expertise will be critical in shaping our data strategies and ensuring our clinical data is submission-ready and meets all global regulatory standards.

📈 Career Progression

Typical Career Path

Entry Point From:

Senior Clinical Data Manager
Principal Clinical Data Manager
Senior Clinical Research Associate (with a strong data focus)

Advancement To:

Manager/Associate Director, Clinical Data Management
Director, Clinical Data Operations
Head of Clinical Data Sciences

Lateral Moves:

Clinical Trial Manager
Clinical Systems Manager
Statistical Programmer

Core Responsibilities

Primary Functions

Provide strategic leadership and technical oversight for all data management activities across assigned clinical trials, from protocol review through study close-out and final reporting.
Author, review, and finalize critical study documentation, including Data Management Plans (DMPs), eCRF Completion Guidelines (CCGs), Data Validation Specifications (DVS), and User Acceptance Testing (UAT) plans.
Lead the design, development, and testing of clinical databases (eCRFs) within Electronic Data Capture (EDC) systems, ensuring alignment with study protocols and CDASH/SDTM standards.
Manage and oversee the activities of external data management vendors and Contract Research Organizations (CROs), ensuring adherence to contractual obligations, timelines, and quality standards.
Function as the primary data management subject matter expert (SME) on cross-functional study teams, providing guidance and insights to Clinical Operations, Biostatistics, and Medical Monitors.
Develop and execute comprehensive data cleaning strategies, overseeing the entire query management process to ensure the timely resolution of all data discrepancies.
Lead and perform thorough data review activities, including manual and programmatic checks, to ensure the overall quality, integrity, and consistency of clinical trial data.
Coordinate and manage the reconciliation of external data from various sources (e.g., central labs, IxRS, ePRO, wearables) with the clinical database.
Oversee and direct all database lock and data extraction activities, ensuring all quality checks are complete and documentation is in place for regulatory submissions.
Mentor, train, and guide junior Clinical Data Managers and Clinical Data Associates, fostering their professional growth and ensuring consistency in team performance.
Represent the Data Management function during regulatory inspections and internal audits, confidently speaking to processes, documentation, and data quality.
Drive the development, review, and implementation of departmental Standard Operating Procedures (SOPs), Work Instructions, and best practices to enhance efficiency and compliance.
Proactively identify and mitigate risks related to data management timelines, quality, and budget, developing and implementing effective contingency plans.
Lead User Acceptance Testing (UAT) for new databases, database updates, and migration projects, meticulously documenting testing outcomes and ensuring system functionality meets study requirements.
Generate and distribute key data management metrics, status reports, and listings to study teams and senior management to provide clear visibility into data collection and cleaning progress.
Collaborate closely with Biostatistics and Statistical Programming to ensure data structures and deliverables (e.g., SDTM datasets) are fit-for-purpose for analysis and reporting.
Manage study-specific timelines for all data management deliverables and ensure all tasks are completed within the established project milestones.
Perform medical coding (e.g., MedDRA, WHODrug) review and ensure consistency and accuracy in the application of coding conventions across the study.
Participate in the evaluation and selection of new data management technologies, systems, and vendors to drive innovation and efficiency within the department.
Ensure all data management activities are conducted in strict compliance with GCP, 21 CFR Part 11, and other applicable global regulatory requirements (e.g., GDPR).
Serve as the technical lead for complex data-related problem-solving, troubleshooting issues with EDC systems, data integrations, and reporting tools.
Coordinate with Safety/Pharmacovigilance teams to ensure the timely and accurate reconciliation of Serious Adverse Event (SAE) data between the clinical and safety databases.

Secondary Functions

Support ad-hoc data requests and exploratory data analysis for publications or internal reviews.
Contribute to the organization's data strategy and the continuous improvement of data management processes.
Collaborate with business units to translate data needs into engineering and system requirements.
Participate in sprint planning and agile ceremonies if the data management team operates within an agile framework.

Required Skills & Competencies

Hard Skills (Technical)

Advanced EDC Proficiency: Expert-level knowledge and hands-on experience with major EDC systems such as Medidata Rave, Oracle InForm, or Veeva Vault EDC.
CDISC Standards: Deep understanding and practical application of CDASH, SDTM, and ADaM standards for data collection, tabulation, and regulatory submission.
Data Reconciliation: Proven ability to manage and reconcile various external data types, including central lab data, IxRS, ePRO/eCOA, and imaging data.
Query Languages: Working knowledge of SQL for data interrogation, quality checks, and ad-hoc reporting is highly desirable.
Reporting & Visualization Tools: Experience with data review tools (e.g., J-Review, Medidata TSDV) and visualization platforms (e.g., Spotfire, Tableau) for metrics tracking.
SAS Programming: Basic to intermediate knowledge of SAS for reviewing data listings and validating programmed checks is a significant plus.
Medical Coding Systems: Strong familiarity with medical coding dictionaries such as MedDRA and WHODrug and their practical application in a clinical trial setting.

Soft Skills

Leadership & Mentorship: Demonstrated ability to lead project teams, manage vendors, and effectively mentor junior staff to foster talent development.
Cross-Functional Collaboration: Exceptional ability to work collaboratively and communicate effectively with diverse teams including Clinical Operations, Biostatistics, Regulatory, and Quality Assurance.
Project Management: Strong organizational and project management skills, with the ability to manage multiple complex projects simultaneously and meet aggressive timelines.
Strategic Problem-Solving: Excellent critical thinking and advanced problem-solving skills with a proactive, solutions-oriented mindset.
Meticulous Attention to Detail: An unwavering commitment to delivering high-quality, accurate, and consistent data.
Impactful Communication: Superior written and verbal communication skills, capable of presenting complex data concepts clearly and persuasively to a variety of audiences.

Education & Experience

Educational Background

Minimum Education:

Bachelor’s degree.

Preferred Education:

Master’s degree or advanced certification (e.g., Certified Clinical Data Manager - CCDM®).

Relevant Fields of Study:

Life Sciences, Health Sciences
Computer Science, Biostatistics, Nursing, or a related scientific discipline.

Experience Requirements

Typical Experience Range:

8+ years of progressive experience in clinical data management within the pharmaceutical, biotechnology, or CRO industry.

Preferred:

A minimum of 3 years of experience in a lead or senior-level role, with direct responsibility for overseeing entire studies from start to finish and/or mentoring staff. Direct experience with regulatory submissions (NDA, BLA, MAA) is highly preferred.