Responsible for the provision of technical eCOA advice to support the selection and of eCOA technologies and to undertake technical implementation activities for use of eCOA in Clinical projects across all Therapeutic Area Business Units within Clinical Development.
The role holder will be assigned to the project team to support the eCOA set-up and implementation working with the eCOA vendor and project team and will provide ongoing technical support in the management and resolution of issues related to eCOA technologies.
• Assist with assessment and interpretation of the project protocol eCOA requirements
• A ssist with regional requirement review and language translations that are required
• Attends internal and sponsor calls to discuss the optimal eCOA technology for projects
• A ttendance to the Trusted Process meetings related to eCOA agenda items
• Development of the eCOA technical specification for system set up, interacting with the vendor to ensure development of the system meets the project requirements
• Development and execution of the test scripts and user acceptance testing of the system development
• Responsible for production readiness
• Develops study specific site user guide documentation
• Responsible for quality of system development, ensuring testing is sufficient to cover all requirements in particular system integrations
• Monitoring of system in production to ensure it is functioning as required
• Ensures assigned tasks are completely on time and within budget
• Responsible for ensuring all project documentation is filed completely and accurately in the TMF
• Input to eCOA vendor qualification and provision of feedback on performance of eCOA technology vendors to Vendor Management as part of the ongoing vendor assessment
• Issue management and resolution, working with the project team, vendor and sponsor
• Provision of status updates to the eCOA project manager
• Acts as Process owner for eCOA procedural documents and associated training
• Serves as an eCOA Subject Matter Expert (SME) on corporate and departmental initiatives
• May be required to participate in client, internal or agency audits and inspections
• 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
• BA/BS in the biological sciences or related disciplines in the natural science/health care field or Registered Nurse. In lieu of degree, equivalent relevant work experience.
• Years of experience required: Minimum of seven (7) years of data management experience, including three (3) years of managing data management projects.
• Clinical data management experience or an equivalent combination of education and experience.
• Experience in Clinical Data Management practices and relational database management software systems.
• Strong project management skills and knowledge of project management methodologies
• Demonstrated staff leadership skills.
• Contract Research Organization (CRO) experience preferred.
• Direct exposure to Oracle Clinical, Rave, or Inform systems. Knowledge of medical terminology, clinical data, and ICH/Good Clinical Practices.
• Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications.
• Effective oral and written communication skills.
• Strong presentation skills
• Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail.
• Ability to be flexible and adapt to change, to work independently, as well as part of a multi-disciplinary team.
• Ability to make effective decisions and manage multiple priorities in a highly dynamic environment.