Associate Specialist, Clinical Data Management - Hybrid

MSD•Upper Gwynedd Township, PA

3d•$71,900 - $113,200•Hybrid

About The Position

The Associate Specialist, Clinical Data Management is responsible for clinical programming deliverables, including reporting and analytics, across Oracle and Veeva platforms and external data captured for clinical studies. The role designs, builds, maintains, tests, and documents data reviews according to written specifications established by Global Clinical Data Management, Clinical Research, and Global Safety. It evaluates the technical feasibility of study team requests and implements programming and reporting solutions. The position supports data cleaning, medical review, clinical monitoring, and safety reporting to ensure information is available accurately and on time. It provides ongoing support for In-Life Reports and ensures change requests and incident reports are documented, approved, tracked, and reported to management. The specialist also contributes to study-improvement task forces, automation initiatives, new-system testing, training, and mentoring. This is a hybrid role based primarily in Rahway, New Jersey, with a stated 10% travel requirement.

Requirements

Must hold a B.A. or B.S. degree, preferably in mathematics, science, a healthcare-related discipline, or computer science, or receive such a degree no later than spring 2027; relevant Pharma skills and experience are also referenced as an education alternative.
Technical proficiency in clinical data management or reporting systems such as Power BI, SQL/PL SQL, Databricks, Python, or SAS, and AI-related tools.
Knowledge of MS Windows and Office software and exposure to web-based applications.
Knowledge of System Development Lifecycle Management and system validation.
Ability to establish and maintain effective working relationships across functional areas.
Strong customer focus and sense of urgency.
Excellent communication skills and ability to interact effectively with study teams.
Strong organizational and problem-solving skills.
Ability and desire to learn new processes and technologies.
Ability to multitask and work independently.
Understanding of the drug discovery process, FDA regulations, GxP guidelines, and ICH.
Valid driving license.

Responsibilities

Deliver clinical programming, reporting, and analytics, including work with Oracle, Veeva platforms, and external clinical study data.
Design, build, maintain, test, and document data review based on written specifications from Global Clinical Data Management, Clinical Research, and Global Safety.
Assess the technical feasibility of study team-proposed programming and reporting and implement feasible solutions.
Collaborate with the team to communicate issues and ideas for business improvement and understand study protocols.
Support development and reporting for data cleaning, medical review, clinical monitoring, and safety reports.
Provide ongoing support for In-Life Reports.
Ensure change requests and incident reports are documented, signed off, tracked, and reported to upper management.
Participate in study-improvement task forces, automation initiatives, new-system testing, and ongoing training and mentoring.