Senior Specialist, Clinical Data Management, Hybrid

MSD•Rahway, NJ

8h•Hybrid

About The Position

The 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 managing and enforcing COA systems Standards. The COA Sr. Specialist also monitors system change requests and acts as the Company’s COA systems subject matter expert while liaising with external vendors. This role is accountable for making decisions regarding COA process, issue resolution, and deviations from standards. The specialist applies COA systems expertise on day-to-day activities when issues are escalated, communicates with internal and external stakeholders, and escalates risks. This role may participate and lead in process improvement initiatives, standards development and maintenance. The specialist is responsible for creating and enforcing COA systems standards, managing vendor performance, and supporting training & education of stakeholders.

Requirements

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
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 to 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.
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)

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. Responsibilities may include creation / revision of COA systems standards, collaboration with vendors and internal stakeholders to define requirements, and monitoring standards utilization rate.
Performs peer-review of the COA systems specific documentations for quality (e.g. comparing paper COA measures with Developer version etc.).
Manages vendor performance and relationship(s). Responsibilities may include defining and implementing process with vendor representatives, monitoring and analyzing vendor and our Company's performance metrics, performing root cause analysis and identifying corrective actions, and serving as point of escalation for vendor issues.
Serves as project manager of all COA systems activities for protocols assigned. Uses interpersonal, negotiating, and project management skills to perform the following tasks: Project plan development, execution, and change control. Coordinates resolution & risk mitigation of all COA systems related issues and end of study vendor deliverables Activity definition and sequencing, duration estimation, schedule development, and schedule control. Risk management planning (i.e., risk identification, analysis, and response planning, as well as risk monitoring and control). Communication planning, information distribution, performance reporting, and project closure.
Obtains internal and external stakeholder feedback; this may include meeting with vendor project managers and/or meeting with subject matter experts or representatives from stakeholder functional areas.
Provides support for successful integration of our Company and vendor systems.
Provides support for problem resolution between COA vendors and our 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.