Associate Specialist, Clinical Data Management

MSD•Upper Gwynedd Township, PA

2d•$71,900 - $113,200•Hybrid

About The Position

Under the direction of applicable management, the Clinical Data Manager is responsible for executing end-to-end data management activities for clinical trials. These activities include developing, validating, and maintaining data management tools and systems; collecting data; reviewing data integrity and performing reconciliations; managing queries; medical coding; and preparing for database lock, in compliance with company Standard Operating Procedures (SOPs) and ICH-GCP guidelines. The role supports clinical trial data management activities under the direction of the Senior/Lead Clinical Data Manager. It helps ensure data quality, timely resolution of identified issues, compliance with process expectations, and completion of trial-level archiving. The position is based in West Point, Pennsylvania, with a hybrid work arrangement and a first-shift schedule.

Requirements

High school diploma or equivalent.
Self-motivated, with excellent work planning and time-management skills.
Fluent oral and written English skills.
Good awareness of regulations and policies.
Ability to work under pressure and adapt flexibly in a changing environment.
Good communication skills, including the ability to communicate with technical and business areas.
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, and teamwork.

Nice To Haves

B.A. or B.S. degree in medicine, pharmacy, nursing, biological sciences, or a healthcare-related discipline.

Responsibilities

Participate in the development of data management tools and systems and implement change requests for clinical trial data management activities under the direction of the SCDM/LCDM.
Run data integrity check reports in accordance with data review plans and relevant SOPs.
Raise questions to investigational site staff and internal and external vendors, and review responses and corresponding data corrections to confirm resolution of identified issues.
Execute user acceptance testing of data management tools under the guidance of the SCDM/LCDM.
Escalate overdue items, including outstanding questions and missing visits.
Assist the Senior/Lead CDM with data management activities to resolve identified data issues before study database lock.
Complete trial-level archiving activities, including filing essential documentation, under the direction of the SCDM/LCDM.
Maintain compliance with standard key performance indicators at the protocol level.
Monitor data quality and cycle-time performance measures, perform root cause analysis, and implement action plans as needed.
Proactively communicate project status, risk assessments, and outstanding-item resolution status to the Senior/Lead CDM.