The Associate Clinical Business Analyst is responsible for supporting the project manager with project execution and administrative activities. Key responsibilities are focused on supporting process improvement or technology initiatives aligned with strategic departmental goals, working closely with project teams to understand their operational obstacles and supporting various change management and process improvement initiatives aimed at achieving clinical study operational efficiencies and departmental goals.
- Administrative support for project management team within BIO including meeting scheduling and meeting minutes
- Supports the development of a Project Execution Strategy, Scope and Charter by aligning key objectives highlighted by the project team and quality objectives.
- Support BIO in business application development and change management activities, acting as a supporting role in requirements gathering, project management and user acceptance testing
- Support GCO (and other GMDA functions) in the implementation and adoption of new systems, system features, business tools and associated processes
- Help to train and guide end-users, functions and key stakeholders in better understanding the overall impact of data ownership, data quality and data integrity
- Assist in the development and maintenance of training materials, business guidelines and associated tools used for clinical trial operational data capture, management and reporting
- Serve as an ambassador of BIO and build and maintain strong relationships across the organization in support of cross-functional alignment and awareness
- Performs other duties as assigned
TECHNICAL AND COMMUNICATIVE SKILLS:
- Ability to work as a part of a team and independently
- Demonstrates basic knowledge of clinical trial process and ICH GCP regulations
- Possesses sound communication skills, sufficient to clearly understand detailed instructions and make himself/herself well understood on basic clinical trial topics
- Exhibits reliable ability to independently prepare and process routine documentation
- Familiarity with project management approaches, tools and phases of the project lifecycle.
- Demonstrated proficiency using Microsoft Office applications required (including MS Visio, Excel, MS Project, SharePoint).
PREFERRED EDUCATION AND EXPERIENCE:
- B.S. (or equivalent experience) and 1 – 3 years of relevant work experience