Sr. Spclst, Clinical Data Mgmt

Merck•Upper Gwynedd Township, PA

2d•$117,000 - $184,200•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 will monitor system change requests, act as the Company’s COA systems subject matter expert, and liaise with external vendors. They will be accountable for making decisions regarding COA processes, issue resolution, and deviations from standards, applying COA systems expertise to day-to-day activities when issues are escalated. The role involves communicating with internal and external stakeholders, escalating risks, and potentially participating in or leading process improvement initiatives, standards development, and maintenance. Responsibilities also include creating and enforcing COA systems standards, managing vendor performance, and supporting training and education for stakeholders.

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.
Define/redesign COA development processes across vendor base. Identify areas for process improvement and lead improvement activities.
Create and enforce 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.
Perform peer-review of the COA systems specific documentations for quality (e.g. comparing paper COA measures with Developer version etc.).
Manage 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.
Serve as project manager of all COA systems activities for protocols assigned. Use interpersonal, negotiating, and project management skills to perform tasks such as project plan development, execution, and change control; coordinate 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; and communication planning, information distribution, performance reporting, and project closure.
Obtain 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.
Provide support for successful integration of our Company and vendor systems.
Provide 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.