Specialist, Clinical Data Management – Hybrid

Merck•Upper Gwynedd Township, PA

3d•$87,300 - $137,400•Hybrid

About The Position

This role is responsible for all clinical programming (including reporting and analytics) deliverables, utilizing platforms like Oracle and Veeva, as well as managing external data captured for clinical studies. The Specialist will coordinate and participate in the design, build, maintenance, testing, and documentation of data reviews based on specifications from Global Clinical Data Management, Clinical Research, and Global Safety. They will review the technical feasibility of study team programming/reporting proposals and implement them technically. The role requires effective teamwork to communicate issues and ideas for business improvement, along with an understanding of the Protocol. Support will be provided for data cleaning, medical review, clinical monitoring, and safety reports to ensure quality and timely availability for customer needs. Ongoing support for In-Life Reports, Change Requests, and Incident Reports is expected, with full documentation, sign-off, tracking, and reporting to upper management. Participation in additional activities such as study improvement task forces, automations, initiatives, new system testing, and training/mentoring is also part of the role.

Requirements

B.A. or B.S. degree, preferably in mathematics, science, a healthcare-related discipline, or computer science; or relevant Pharma skills and experience.
4+ years’ experience in SQL, PL-SQL, PowerBI
Strong technical proficiency in a Clinical Data Management/Reporting Systems like Databricks, Python, SAS, etc along with AI related tools.
Solid knowledge of MS Windows/Office 365 suit software and exposure to web-based applications.
Solid knowledge of System Development Lifecycle Management / system validation knowledge
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 along with Strong organizational and problem-solving skills.
Desire and ability to learn new processes and technologies
Ability to multi-task, work independently, and good communication skills
Understanding of drug discovery process, FDA regulations, GxP guidelines, ICH

Nice To Haves

Adaptability
Clinical Data Cleaning
Clinical Data Management
Customer-Focused
Data Analysis
Database Development
Data Processing
Data Quality Assurance
Data Review
Data Validation
Data Visualization
Electronic Data Capture (EDC)
Learning Agility
Pharmacovigilance
PL/SQL (Programming Language)

Responsibilities

Assume responsibilities for all clinical programming (including reporting and analytics) deliverables including Oracle, Veeva platforms along with the external data captured in support of the clinical studies.
Coordinate and participate in the design, build, maintain, test, and document data review based on written specifications established by Global Clinical Data Management, Clinical Research and Global Safety.
Review the technical feasibility of study team proposed programming/reporting and technically implement them.
Work effectively among team to communicate issues and ideas to improve the business along with understanding of Protocol.
Support the development & reporting for data cleaning, medical review, clinical monitoring, and safety reports for quality and timely availability in support of our customer needs.
Perform ongoing support for In-Life Reports. Change Requests and Incident Reports are fully documented, signed off, tracked, and reported to upper management.
Participate in extra activities including, but not limited to, study improvement task forces, automations, initiatives, testing of new systems, and ongoing training and mentoring.