This position is responsible for directly project managing the overall implementation and ongoing oversight of eCOA systems for assigned projects. Interacts with the sponsor, vendor and clinical study teams to gather requirements; oversees all activities related to the study to ensure timelines are met within budget; oversees the implementation of the system into production; oversees day-to-day eCOA project activities throughout the project through to project completion. May have supervisory responsibility and/or oversight for a team.
- Communicates information on applicable eCOA project activities to stakeholders, including the internal and sponsor study teams. Serves at the central point of contact for all eCOA assigned project-related project issues.
- Reviews and provides input on study budgets, manages project level metrics, progress, and status. Assists with the creation of change orders.
- Provides regular updates to project teams on status of implementation efforts and issues; resolves conflicts in information and ensures that accurate and timely information is provided to all team members throughout the duration of the project for all system related issues.
- Responsible for protocol review, study requirement gathering and interpretation required for eCOA implementation and study design. Provides input to architect design and data flow/approaches. Obtains approval of required document(s). Identifies forms, questionnaires or assessments to be captured in eCOA
- Develops timelines in coordination with study team for all newly assigned projects from start up to project closeout; coordinates key milestones with all stakeholders (including subsequent adjustments of milestones).
- Responsible for quality of system configuration, ensuring testing is sufficient to cover all requirements and monitoring of system in production to ensure it is functioning as required. Ensures internal (and sponsor if required) completion of user acceptance testing of system is completed.
- Ensures tasks are completely on time and within budget according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations
- Provides project-specific training to internal and external audiences as required. Trains and mentors internal team members, Acts as a subject matter expert
- Tracks ongoing system support; works with study team, vendor or support as needed to improve support response and/or to reduce support issues. Identifies risk and mitigation plan.
- Responsible for ensuring project documentation is maintained on an ongoing basis and ensures required documentation is filed completely and accurately in the TMF, including signatures where necessary.
- Create Device management Plan, work with Syneos Site contact to ensure execution of the plan. Identifies and reviews instrument licenses required
- Attends Bid Defense Meetings to present eCOA functionality, scope and services.
- Maintains proficiency in eCOA systems and processes through regular training and/or attendance at professional meetings/conferences. Takes the opportunity to network with colleagues for new and/or repeat business. May represent the Company at professional meetings or seminars.
- Participate in client, internal or agency audits and inspections