Clinical Data Manager - End-to-End Trial Data Excellence

Merck; West Point (PA); Hybrid; USD 72,000 - 113,000; Full time

Job summary

Merck is seeking a Clinical Data Manager to execute end-to-end data management activities for clinical trials, including data management tool development, validation, data collection, data integrity, query management, medical coding, and database lock preparation. The role requires strong communication, regulatory awareness, and ability to work under pressure in a changing environment.

Responsibilities include supporting UAT, data quality monitoring, and archiving activities under the guidance

Qualifications

• High School Diploma (or equivalent).
• Preferred: B.A. or B.S. degree, in Medicine, Pharmacy, Nursing, Biological Sciences, or health care related discipline.
• Self-motivated, excellent in work planning and time management.
• Fluent oral and written English skills.
• Good sense and awareness of regulations and policies.
• Able to work under pressure and in a changing environment with flexibility.
• Good communication skills with the ability to communicate with both the technical and business areas.

Responsibilities

• Participates in the development and change request implementation of data management tools and systems for the clinical trial data management activities under the direction of the SCDM/LCDM
• Runs data integrity check reports in accordance with data review plans and relevant SOPs.
• Raises questions to investigational site staff and internal and external vendors, reviews responses and corresponding data corrections to confirm identified issue resolution.
• Responsible for the execution of user acceptance testing of data management tools under the guidance of the SCDM/LCDM.
• Escalates overdue items, including but not limited to outstanding questions and missing visits.
• Assists the Senior/Lead CDM with data management activities to resolve all identified data issues prior to study database lock.
• Complete trial level archiving activities under the direction of the SCDM/LCDM including, but not limited to, filing of essential documentation.
• Maintains compliance with standard key performance indicators according to process expectations at the protocol level.
• Monitors data quality and cycle-time performance measures to maintain compliance, performs root cause analysis and implements action plans as needed.
• Proactively communicates with Senior/Lead CDM to share project status, risk assessment and outstanding item resolution status.

Skills

Adaptability

Analytical Problem Solving

Clinical Data Cleaning

Clinical Data Management

Data Collection Methods

Data Documentation

Data Integrity

Data Processing

Data Reporting

Data Review

Data Validation

Document Management

GCP

Project Management

Teamwork

Education

High School Diploma (or equivalent)

B.A. or B.S. degree in Medicine, Pharmacy, Nursing, Biological Sciences, or health care related discipline

Job description

Merck is seeking a Clinical Data Manager to execute end-to-end data management activities for clinical trials, including data management tool development, validation, data collection, data integrity, query management, medical coding, and database lock preparation. The role requires strong communication, regulatory awareness, and ability to work under pressure in a changing environment.

Responsibilities include supporting UAT, data quality monitoring, and archiving activities under the guidance