Sr. Spclst, Clinical Data Mgmt

MSD•Rahway, NJ

1d•Hybrid

About The Position

The COA Sr. Specialist is responsible for providing end-to-end COA systems project management support. This includes gathering study-specific user requirements, executing UAT tasks, managing project timelines, and enforcing COA systems standards. The specialist also monitors system change requests and acts as the company’s COA systems subject matter expert, liaising with external vendors. They are accountable for making decisions regarding COA processes, issue resolution, and deviations from standards, applying COA systems expertise to escalated issues. The role involves communicating with internal and external stakeholders, escalating risks, and potentially leading process improvement initiatives and standards development. Responsibilities include creating and enforcing COA systems standards, managing vendor performance, and supporting stakeholder training and education.

Requirements

6 years’ experience in Clinical Data Management
at least 4 years’ of COA working experience
Demonstrate knowledge of COA systems development processes
Knowledge of the clinical development process, preferably through submission.
Thorough knowledge of clinical data management
Effective written and verbal communication skills
Ability independently perform and manage multiple tasks at one time and meet deadlines in a complex environment working both internal to our Company and external to our Company.
Adaptability
Clinical Data Management
Clinical Information Systems
Communication
Data Validation
Good Clinical Practice (GCP)
Project Management
Stakeholder Analysis
Standards Compliance
Teamwork
Vendor Management

Responsibilities

Execute COA systems development process from Kickoff to system go live, ongoing system change control, system closeout and database lock activities.
Defines/redesigns COA development processes across vendor base.
Identifies areas for process improvement and leads improvement activities.
Creates and enforces the use of COA systems standards.
Performs peer-review of the COA systems specific documentations for quality.
Manages vendor performance and relationship(s).
Serves as project manager of all COA systems activities for protocols assigned.
Uses interpersonal, negotiating, and project management skills to perform tasks such as project plan development, execution, and change control.
Coordinates resolution & risk mitigation of all COA systems related issues and end of study vendor deliverables.
Obtains internal and external stakeholder feedback.
Provides support for successful integration of company and vendor systems.
Provides support for problem resolution between COA vendors and the company's Clinical Trial Team.
May participate in training and education for stakeholders.
May develop, or assist in development of, reference and/or training material.
May provide cross-functional internal and external communication as needed.
May provide support for the development / maintenance of relevant documentation, including applicable SOPs, job aids, and guidance documentation.
May mentor new staff.
May lead a continuous improvement special project or any other project or perform any other COA related task deemed appropriate by management.