Lead Clinical Data Manager

Job Description

Lead Clinical Data Manager (LCDM)

Position Overview:

Under the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management activities pertaining to clinical trials, including but not limited to data management tool and system development, validation and maintenance, data integrity review and reconciliation, query management, and database lock preparation/execution, in compliance with Standard Operating Procedures (SOPs) and ICH-GCP guidelines. Works with management to maintain the consistent execution of quality global procedures. If applicable, monitors workload and resource allocation. Supports the comprehensive development of junior staff and encourages effective interaction with business partners to achieve common objectives. Is accountable for the quality and timely execution and delivery of deliverables at the trial level.

In addition, the LCDM may be appointed to Lead quality and maintenance of any new/updated eDT/eCRF and its associated Data Validation (DV) components across all Standards Libraries by ensuring the appropriate use of Core/Generic, TA and Industry Standards concepts.

Primary activities include, but are not limited to:

• All responsibilities of a Senior Clinical Data Manager (SCDM) and a Clinical Data Manager (CDM).

Trial Level

• Responsible for all protocol level start-up, in-life and database lock tasks and activities.
• Interact and communicate with customers and stakeholders both internal and external to GDMS when needed.
• Responsible to design, create, validate, review, approve and maintain data management tool specifications, including but not limited to: eCRFs, Time & Events Schedules, eCRF Entry Guidelines, Edit Checks, Data Review Plans (DRPs) and In-life Reports, Encoding and Data Management Plans (DMPs).
• Coordinate &/or participate in the execution of user acceptance testing of data management tools.
• Provide inputs into the preparation of the investigator meetings materials and makes him/her available for questions. May present data management instruction at investigator meetings based on business need and management decision.
• Participate in relevant operational meetings to identify and incorporate global operational issues into the study design.
• Execute and trigger communications and escalations at the protocol level within department, within function and cross-functionally.
• Execute and maintain adherence to a metrics control plan and quality assessment indicators at the trial level.
• Coordinate the database lock preparation and monitoring of checks, such as data flow and derivations monitoring, for clinical data repository and triage issues according to report output.
• Accept and execute special responsibilities related to process maintenance, data quality assessment, staff training and mentoring and/ or other special activities, such as developing and delivering programs and materials to instruct staff regarding business processes, leading or participating in cross functional technical improvement projects, etc.
• Continually monitor for opportunities to improve efficiency, effectiveness and quality and implement changes as appropriate at the trial level, program level, TA level and department level.
• Performs tasks with minimal guidance from manager(s).
• Support and execute any role or task in the team when needed.
• Primary responsibility in training new staff (CDMs, SCDMs and new LCDMs).

Education/Experience:

• At least B.A. or B.S. degree, preferably in life science, computer science, or health care related discipline with at least 3 years’ professional experience in clinical data management. OR
• Associate degree with at least 5 years’ professional experience in clinical data management;

OR

• High School Diploma (or equivalent) with at least 8 years’ professional experience in clinical data management.

Preferable Knowledge and Skills:

· Knowledge of database structures and available tools to manage, extract, and report data is preferred.

· Fluent Oral and written English language skills.

· Knowledge of applicable regulations and policies.

· Proficient overall working knowledge of the clinical development process.

· Good working knowledge of clinical practice and medical terminology.

· Ability to work cross functionally and as part of a team.

· Be able to work under pressure in a changing environment with flexibility.

· Ability to work independently and accept and act with appropriate accountability with minimal guidance by a manager.

· Ability to coordinate the work of others and influence decision making.

· Exceptional communication skills (oral and written) with the ability to communicate with both the technical and business areas.

· Exceptional organizational, problem-solving and negotiating skills.

· Demonstrated excellent project management and leadership skills.

· Proficient in Microsoft Office, especially MS Excel.

· General understanding of CDISC/Study Data Tabulation Model (SDTM) and corresponding implementation guides, CDISC terminologies and the related regulations for submission deliverables.

Required Skills: Adaptability, Business Processes, Clinical Databases, Clinical Data Management, Clinical Development, Clinical Research, Clinical Trials, Communication, Customer Communications, Data Analysis, Database Structures, Data Quality Assurance, Data Reporting, Data Review, Data Validation, Good Clinical Practice (GCP), Interpersonal Communication, Medical Terminology, Microsoft Office, Pressure Management, Project Coordination, Teamwork, Vendor Management, Working Independently, Works Under Pressure

Preferred Skills:

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Employee Status: Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:04/21/2026

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