Associate Specialist, Clinical Data Management

MSD; West Point (PA); On-site; USD 90,000 - 130,000; Full time

Job summary

MSD seeks a Clinical Data Manager to lead end-to-end data management activities for clinical trials, including data tool development, validation, data collection, data integrity, query management, medical coding, and database lock preparation in line with SOPs and ICH-GCP. Responsibilities include running data integrity checks, managing queries, assisting with UAT, and ensuring timely archiving.

Strong planning, communication, and regulatory knowledge are required; a BA/BS in a health field is

Qualifications

• High School Diploma (or equivalent); BA/BS preferred in a related health field.
• Strong written and spoken English communication.
• Knowledge of ICH-GCP and SOPs; regulatory awareness.
• Ability to work under pressure in a dynamic environment; flexible to change.
• Experience with data management processes and trial data lifecycle.

Responsibilities

• Execute end-to-end data management activities for clinical trials.
• Develop, validate, and maintain data management tools and systems.
• Run data integrity checks and reconcile data quality issues.
• Manage data queries, medical coding, and database lock preparation.
• Participate in UAT and issue escalation with sites and vendors.
• Archive essential trial documentation per SOPs.
• Communicate project status, risks, and resolution steps to leadership.

Skills

Adaptability

Analytical thinking

Clinical data cleaning

Clinical data management

Data collection

Data documentation

Data integrity

Data processing

Data reporting

Data review

Data validation

Document management

GCP (Good Clinical Practice)

Project management

Teamwork

Education

High School Diploma (or equivalent)

B.A./B.S. in Medicine, Pharmacy, Nursing, Biological Sciences, or related health care field

Job description

Position Overview

Under the direction of the applicable management, the Clinical Data Manager (CDM) 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 collection, data integrity review and reconciliation, query management, medical coding, and database lock preparation, in compliance with our Company's Standard Operating Procedures (SOPs) and ICH-GCP guidelines.

Primary activities include, but are not limited to: 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.

Education Requirement

High School Diploma (or equivalent).

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

Knowledge and Skills

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.

#MSJR Required 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, Good Clinical Practice (GCP), Project Management, Teamwork

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual