Program Manager (Reporting, Archiving and Mapping) - Hybrid

Merck•Upper Gwynedd Township, PA

1d•Hybrid

About The Position

Primary activities include, but are not limited to: Serves as a Subject Matter Expert in Clinical Programming supporting study build, reporting and analytics. Leads efforts to standardize, simplify, and optimize processes through best practices and continuous improvement initiatives. Provides technical leadership and oversight for Clinical Programming (including reporting and analytics) deliverables across programs, including review of eCRFs, required specification, understanding of Protocol, In-Life Report specifications, and library development. Ensures compliance with established standards, SOPs, and process guidelines while proactively managing timelines and escalating risks related to reporting assets and data flow. Partners closely with study teams, Leadership, and external vendors to translate study requirements into high-quality solutions and aligned technical approaches. Provides clear technical direction and ensures consistency across deliverables supporting business needs along with proper facilitation. Supports the development of team members through technical mentoring, training, and participation in hiring and performance feedback. Ensures adherence to standards in the development, documentation, and maintenance of libraries.

Requirements

Bachelor’s degree in computer science or equivalent educational exposure to software design, procedure language, development theory and techniques, testing methodologies, and software documentation along with Pharma skills.
Minimum of 7+ years’ experience in technology acquisition and implementation focused on data transformations, data flow, data loading, and reporting writing (e.g, , SQL, PL-SQL, Java, , /DMW,Veeva,Databricks, Python, Legacy SAS, etc) along with AI related Claude Code tools).
4 years of project management experience. (Either one project for a year or multiple projects.)
Demonstrates a high level of understanding with the design and development of electronic Case Report Forms (eCRFs), clinical databases and other methods of capturing and transferring data, clinical database development tools, ETL tools, reporting tools, standards and the development process in support of clinical research.
Knowledge of Electronic Data Capture Systems or Data Management Systems
Solid knowledge of MS Windows/Office software and exposure to web-based applications.
Ability to establish and maintain good working relationships with different functional areas.
Strong sense of urgency and customer focus.
Possesses excellent communication skills and interacts effectively with Study Team.
Strong organizational, time management, and multi-project coordination skills.
Broad knowledge of Clinical Development and Regulatory Affairs requirements.
Ability to multi-task, work independently, and good communication skills.
Understanding of drug discovery process, FDA regulations, GxP guidelines, ICH guidelines, clinical database cleaning process, and 21 CFR Part 11.
Accountability
Adaptability
Algorithms
Artificial Intelligence (AI)
Artificial Intelligence Techniques
Clinical Database Programming
Clinical Data Management
Clinical Data Standards
Communication
Data Analysis
Data Quality Assurance
Data Reporting
Data Validation
Detail-Oriented
Generative AI
Good Clinical Data Management Practice (GCDMP)
Good Clinical Practice (GCP)
Interpersonal Relationships
Mentoring Staff
Project Management Tools
Strategic Thinking
Team Management

Responsibilities

Serves as a Subject Matter Expert in Clinical Programming supporting study build, reporting and analytics.
Leads efforts to standardize, simplify, and optimize processes through best practices and continuous improvement initiatives.
Provides technical leadership and oversight for Clinical Programming (including reporting and analytics) deliverables across programs, including review of eCRFs, required specification, understanding of Protocol, In-Life Report specifications, and library development.
Ensures compliance with established standards, SOPs, and process guidelines while proactively managing timelines and escalating risks related to reporting assets and data flow.
Partners closely with study teams, Leadership, and external vendors to translate study requirements into high-quality solutions and aligned technical approaches.
Provides clear technical direction and ensures consistency across deliverables supporting business needs along with proper facilitation.
Supports the development of team members through technical mentoring, training, and participation in hiring and performance feedback.
Ensures adherence to standards in the development, documentation, and maintenance of libraries.