Senior Specialist,Clinical Data Management,Hybrid Job Rahway area,New Jersey USA,IT/Tech

Job Description

COA Sr. Specialist is responsible for providing end-to-end COA systems project management support, including gathering study-specific user requirements, executing UAT tasks, managing project timelines, managing and enforcing COA systems standards, and monitoring system change requests. The role serves as the company’s COA systems subject matter expert while liaising with external vendors and making decisions regarding COA processes, issue resolution, and deviations from standards.

Applies COA systems expertise to day‑to‑day activities when issues are escalated, communicates with internal and external stakeholders, and escalates risks. May participate and lead in process improvement initiatives, standards development, and maintenance. Responsible for creating and enforcing COA systems standards, managing vendor performance, and supporting training and education of stakeholders.

Primary Activities

Execute COA systems development process from kickoff to go‑live, ongoing system change control, system close‑out, and database lock activities.

Define/redesign COA development processes across the vendor base, identify areas for improvement, and lead improvement activities.

Create and enforce the use of COA systems standards, including creation or revision of standards, collaboration with vendors and stakeholders, and monitoring standards utilization rate.

Perform peer review of COA systems documentation for quality, comparing paper COA measures with developer versions.

Manage vendor performance and relationships, defining and implementing processes with vendor representatives, monitoring performance metrics, conducting root‑cause analysis, and serving as point of escalation for vendor issues.

Act as project manager of all COA systems activities for assigned protocols, using interpersonal, negotiating, and project‑management skills to:

Develop, execute, and control the project plan and change control.
Define activity sequencing, duration estimation, schedule development, and control.
Plan, identify, analyze, and respond to risks, and monitor and control them.
Plan communication, distribute information, report performance, and close the project.

Obtain stakeholder feedback, including meetings with vendor project managers and functional area experts.

Support integration of company and vendor systems.

Assist in problem resolution between COA vendors and the company’s Clinical Trial Team.

Participate in training and education for stakeholders, developing reference and training materials, and providing cross‑functional communication as needed.

Support development and maintenance of documentation, including SOPs, job aids, and guidance documents.

Mentor new staff members.

Lead a continuous improvement project or any other COA‑related task as deemed appropriate by management.

Education

B.A. or B.S. degree, preferably in life sciences, computer science, engineering, or related discipline.

Experience

Six years’ experience in Clinical Data Management, with at least four years’ COA working experience.

Knowledge and Skills

Demonstrated knowledge of COA systems development processes.
Knowledge of the clinical development process and thorough knowledge of clinical data management.
Effective written and verbal communication skills.
Ability to independently manage multiple tasks concurrently and meet deadlines in a complex environment, working both internally and externally.

Required Skills

Change Management Training
Clinical Data Management
Clinical Development
Process Improvements
Project Management
Project Risk and Issue Management
Regulatory Compliance
Stakeholder Communications
Third‑Party Vendor Management
User Acceptance Testing (UAT)

Preferred Skills

None specified.

US and Puerto Rico Residents Only

Our company is committed to inclusion and only accepts applications from residents of the United States and Puerto Rico.

San Francisco Residents Only

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.

Los Angeles Residents Only

We will consider for employment all qualified applicants, including those with criminal histories, in a manner…

Senior Specialist, Clinical Data Management, Hybrid