Senior Clinical Data Manager - Trial Data Lead

MSD Malaysia; Warszawa; On-site; PLN 180,000 - 240,000; Full time

Job summary

Merck & Co., Inc. is seeking a Senior Clinical Data Manager to lead end-to-end data management activities for clinical trials, ensuring data integrity and adherence to SOPs and ICH-GCP guidelines.

The role involves developing and validating data management tools, coordinating UAT, and communicating with Clinical teams and stakeholders to drive timely database locks and high-quality data for decision-making.

Qualifications

• Minimum 3 years of experience in Data Management, in a Senior Clinical Data Manager or Clinical Data Manager role at the time of application.

Responsibilities

• All responsibilities of a Clinical Data Manager (CDM).
• May be responsible for in-life and database lock tasks and activities.
• Assume data management responsibilities for larger, more complex or higher priority protocols.
• Triage, research, discuss and resolve the reports outputs provided by Clinical & Statistical stakeholders at a protocol level during in-life and database lock stages.
• Execute special reports in different systems and coordinate resolution of the outputs.
• Responsible for the preparation, creation, validation and review of 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 User Acceptance Testing (UAT) of the Clinical Database.
• Responsible for communication with Clinical team regarding site level issues on a protocol.
• Coordinate communications, global status tracking and issue resolution at study level.
• Interact and communicate with customers and stakeholders both internal and external to GDMS as well as internally when needed.
• Responsible for study level status assessment, reporting and communication with LCDM, or with the assigned trial manager.
• Monitor protocol level cycle time performance (metrics) and follow up on specific countries/sites metrics issues and deliver status and resolution updates to appropriate parties.
• May coordinate general ad-hoc Sponsor Data Entry (SDE) process for the protocol, discuss timelines and provide data entry status to Clinical stakeholders.
• Coordinate and mentor CDMs and other SCDMs who work in same protocol to maintain compliance with SOPs, data management plans and data review plans.
• Be assigned to special responsibilities related to process maintenance, data quality assessment, staff training and mentoring and/ or other special activities, such as providing inputs to create or update SOPs, supporting documents and training materials as needed.
• May contribute to special activities such as supporting Process Owner (PO) Models in the local data management center and/or in the Global PO networks.
• Participate in cross functional technical or process improvement projects.

Skills

Clinical Development

Clinical Information Systems

Clinical Research

Clinical Trial Development

Data Management

Data Quality Assurance

Learning Agility

Pharmacovigilance

Study Design

Job description

Merck & Co., Inc. is seeking a Senior Clinical Data Manager to lead end-to-end data management activities for clinical trials, ensuring data integrity and adherence to SOPs and ICH-GCP guidelines.

The role involves developing and validating data management tools, coordinating UAT, and communicating with Clinical teams and stakeholders to drive timely database locks and high-quality data for decision-making.