Lead Clinical Data Manager (LCDM)

1w1 week ago

MSD

Warsaw, PL · Full-time · PLN 200,000 – PLN 280,000

About this role

Under the direction of applicable management, the Lead Clinical Data Manager (LCDM) executes end-to-end data management activities for clinical trials. This includes tool and system development, validation, maintenance, data integrity review, reconciliation, query management, and database lock preparation in compliance with SOPs and ICH-GCP guidelines. The role ensures quality and timely delivery of deliverables at the trial level.

Responsible for all protocol level start-up, in-life, and database lock tasks, the LCDM designs, creates, validates, reviews, approves, and maintains data management tools like eCRFs, Time & Events Schedules, Edit Checks, Data Review Plans, and Data Management Plans. Coordinates or participates in user acceptance testing execution. Provides inputs to investigator meeting materials and may present data management instructions.

The LCDM interacts and communicates with internal and external customers and stakeholders. Participates in operational meetings to incorporate global issues into study design. Executes communications, escalations, and adherence to metrics control plans and quality indicators at the trial level.

Supports development of junior staff through training CDMs, SCDMs, and new LCDMs. Monitors workload, resource allocation, and opportunities to improve efficiency at trial, program, TA, and department levels. Performs tasks with minimal guidance and accepts special responsibilities like process maintenance and mentoring.

Requirements

At least B.A. or B.S. degree, preferably in life science, computer science, or health care related discipline
At least 3 years’ professional experience in clinical data management
All responsibilities of a Senior Clinical Data Manager (SCDM) and a Clinical Data Manager (CDM)
Knowledge of SOPs and ICH-GCP guidelines
Experience with eCRF/eDT, Data Validation components, and Standards Libraries
Ability to perform tasks with minimal guidance from manager(s)
Skills in data quality assessment, process maintenance, and staff mentoring

Responsibilities

Execute end-to-end data management activities including data management tool development, validation, maintenance, data integrity review, reconciliation, query management, and database lock preparation/execution
Design, create, validate, review, approve and maintain data management tool specifications including eCRFs, Time & Events Schedules, eCRF Entry Guidelines, Edit Checks, Data Review Plans, In-life Reports, Encoding and Data Management Plans
Coordinate and/or participate in execution of user acceptance testing of data management tools
Interact and communicate with customers and stakeholders both internal and external
Participate in relevant operational meetings and investigator meetings to provide data management instruction
Execute communications, escalations, metrics control plan, and quality assessment indicators at the protocol level
Coordinate database lock preparation and monitoring of data flow and derivations
Train new staff including CDMs, SCDMs, and new LCDMs