Senior Specialist, Clinical Data Management, Hybrid

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, and enforcing COA systems standards. The role also monitors system change requests, serves as the company’s COA systems subject‑matter expert, liaises with external vendors, and makes 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, escalates risks, and may participate and lead process improvement initiatives, standards development, and maintenance. The position creates and enforces COA systems standards, manages vendor performance, and supports training and education of stakeholders.

• Execute COA systems development process from kickoff to system go‑live, including ongoing system change control, system closeout, and database lock activities.
• Define/re‑design COA development processes across the vendor base and identify areas for process improvement, leading improvement activities.
• Create and enforce the use of COA systems standards, including revision of standards, collaboration with vendors, and monitoring standards utilization.
• Perform peer‑review of COA systems documentation for quality.
• Manage vendor performance and relationships, define processes with vendor representatives, analyze metrics, conduct root‑cause analysis, and act as point of escalation for vendor issues.
• Serve as project manager for all COA systems activities for assigned protocols, using interpersonal, negotiating, and project‑management skills.
• Develop, execute, and control project plans, including task definition, sequencing, estimation, scheduling, risk management, communication planning, information distribution, performance reporting, and project closure.
• Obtain stakeholder feedback and coordinate with vendor project managers and internal subject‑matter experts.
• Support integration of company and vendor systems and resolve problems between COA vendors and the clinical trial team.
• Participate in training and education for stakeholders and develop reference or training materials as needed.
• Maintain relevant documentation, such as SOPs, job aids, and guidance documentation.
• Mentor new staff and lead continuous improvement or other COA‑related projects as directed by management.

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

• 6 years’ experience in Clinical Data Management, with at least 4 years’ of COA working experience.

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

• 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)

• Current employees apply here.
• Current contingent workers apply here.

Our company is committed to inclusion and accommodates applicants during the hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

Salary range: $ – $. The successful candidate may be eligible for an annual bonus and long‑term incentive. Benefits include medical, dental, vision, and other insurance benefits, retirement benefits (401(k)), paid holidays, vacation, and compassionate and sick days.

Travel required:

10%.

Work arrangement:
Hybrid.

Shift: 1st – Day.