Program Manager (Reporting, Archiving and Mapping) - Hybrid
Merck
5 months ago
Remote friendly (Rahway, NJ)
United States
IT
Responsibilities:
- Serve as a Subject Matter Expert in Clinical Programming supporting study build, reporting, and analytics; lead efforts to standardize, simplify, and optimize processes through best practices and continuous improvement.
- Provide technical leadership and oversight for Clinical Programming deliverables across programs, including review of eCRFs, required specifications, understanding of protocol and In-Life Report specifications, and library development; ensure compliance with standards/SOPs/process guidelines; manage timelines and escalate risks related to reporting assets and data flow.
- Partner with study teams, leadership, and external vendors to translate study requirements into high-quality, aligned technical solutions; provide technical direction and ensure consistency across deliverables.
- Support development of team members through technical mentoring, training, and participation in hiring and performance feedback; ensure adherence to standards for development, documentation, and maintenance of libraries.
Qualifications & Experience:
- Bachelor’s degree in computer science or equivalent exposure to software design, procedure language, development theory/techniques, testing methodologies, and software documentation (including pharma skills).
- 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) and AI tools (e.g., Claude Code).
- 4 years of project management experience.
- Experience/understanding of eCRF design/development, clinical databases and data capture/transfer methods, clinical database development tools, ETL tools, reporting tools, and standards/processes supporting clinical research.
- Knowledge of Electronic Data Capture (EDC) or Data Management Systems.
- Solid knowledge of MS Windows/Office and exposure to web-based applications.
- Ability to build and maintain relationships across functional areas; strong urgency and customer focus; excellent communication skills with study teams.
- Strong organization, time management, and multi-project coordination.
- Broad knowledge of clinical development and regulatory affairs; understanding of drug discovery process, FDA regulations, GxP, ICH, clinical database cleaning, and 21 CFR Part 11.
Required/Preferred Skills (as listed):
- Required: Accountability, Adaptability, Algorithms, Artificial Intelligence (AI), Clinical Database Programming, Clinical Data Management, Clinical Data Standards, Communication, Data Analysis, Data Quality Assurance, Data Reporting, Data Validation, Detail-Oriented, Generative AI, GCDMP, GCP, Interpersonal Relationships, Mentoring Staff, Project Management Tools, Strategic Thinking, Team Management.
- Preferred: Current employees/contingent workers apply via the provided internal links.
Application Instructions:
- Apply at https://jobs.merck.com/us/en (or via the Workday Jobs Hub for current employees). Apply no later than the day-before the posted application end date (04/24/2026).
- Serve as a Subject Matter Expert in Clinical Programming supporting study build, reporting, and analytics; lead efforts to standardize, simplify, and optimize processes through best practices and continuous improvement.
- Provide technical leadership and oversight for Clinical Programming deliverables across programs, including review of eCRFs, required specifications, understanding of protocol and In-Life Report specifications, and library development; ensure compliance with standards/SOPs/process guidelines; manage timelines and escalate risks related to reporting assets and data flow.
- Partner with study teams, leadership, and external vendors to translate study requirements into high-quality, aligned technical solutions; provide technical direction and ensure consistency across deliverables.
- Support development of team members through technical mentoring, training, and participation in hiring and performance feedback; ensure adherence to standards for development, documentation, and maintenance of libraries.
Qualifications & Experience:
- Bachelor’s degree in computer science or equivalent exposure to software design, procedure language, development theory/techniques, testing methodologies, and software documentation (including pharma skills).
- 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) and AI tools (e.g., Claude Code).
- 4 years of project management experience.
- Experience/understanding of eCRF design/development, clinical databases and data capture/transfer methods, clinical database development tools, ETL tools, reporting tools, and standards/processes supporting clinical research.
- Knowledge of Electronic Data Capture (EDC) or Data Management Systems.
- Solid knowledge of MS Windows/Office and exposure to web-based applications.
- Ability to build and maintain relationships across functional areas; strong urgency and customer focus; excellent communication skills with study teams.
- Strong organization, time management, and multi-project coordination.
- Broad knowledge of clinical development and regulatory affairs; understanding of drug discovery process, FDA regulations, GxP, ICH, clinical database cleaning, and 21 CFR Part 11.
Required/Preferred Skills (as listed):
- Required: Accountability, Adaptability, Algorithms, Artificial Intelligence (AI), Clinical Database Programming, Clinical Data Management, Clinical Data Standards, Communication, Data Analysis, Data Quality Assurance, Data Reporting, Data Validation, Detail-Oriented, Generative AI, GCDMP, GCP, Interpersonal Relationships, Mentoring Staff, Project Management Tools, Strategic Thinking, Team Management.
- Preferred: Current employees/contingent workers apply via the provided internal links.
Application Instructions:
- Apply at https://jobs.merck.com/us/en (or via the Workday Jobs Hub for current employees). Apply no later than the day-before the posted application end date (04/24/2026).