Description of Role & 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 client 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:

o Project plan development, execution, and change control. Coordinates resolution & risk mitigation of all IRT & COA systems related issues and end of study vendor deliverables.

o Activity definition and sequencing, duration estimation, schedule development, and schedule control.

o Risk management planning (i.e., risk identification, analysis, and response planning, as well as risk monitoring and control).

o 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 client and vendor systems.

• Provides support for problem resolution between COA vendors and client’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.

Minimum FTE Years of Experience

• Minimum of 3 years’ experience in eCOA Project Management

• Able to read and interpret clinical trial protocols

• Effective Verbal and Written Communication Skills

• Attention to detail

• Stakeholder engagement and collaboration experience

• Cross functional collaboration

• Ability to adapt in a fast-paced environment

• Risk management experience

• Familiarity working with Microsoft Project

• 2 days a week in the client office required

Educational Requirements

• B.A. or B.S. degree in Computer Science, Biology, or a related discipline

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