Plan, direct, coordinate, and deliver activities for designated clinical-study projects to ensure that project objectives of quality, scope, cost, and time are accomplished.
Manage regional trials (moderate complexity) and/or act in a supportive role in managing complex global trials.
Serve as primary point-of-contact and primary escalation point to the client.
Coordinate and oversee all functional services including external vendors to the established timeline and budget.
Manage the study budget, ensuring project remains within scope and that any out of scope activities are identified early and handled as appropriate.
Ensure functional areas are fully aware of the study scope and are managing the scope for their functional areas accordingly.
Develop robust and comprehensive project plans, including timelines and proactive risk management and mitigation.
Ensure Quality management for assigned projects, including eTMF Inspection readiness.
Prepare project status updates and report on progress to clients and senior management, including reporting on key performance indicators, offering solutions and opportunities as they arise.
Lead both internal and client meetings and set expectations for the project team.
Communicate effectively with client and Precision management to relay protocol/study issues and implements necessary actions in response to those issues.
Requirements
Degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred
Minimum of 4-7 years of clinical research experience or proven competencies for this position and a minimum of 2-4 years of leading a project
Experience managing regional trials (moderate complexity) and/or supportive role in managing complex global trials
Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint), Microsoft Project, eTMF, EDC and CTMS
Good communication and interpersonal skills to effectively interface with others in a team setting
Good organizational skills, attention to detail, and a customer service demeanor
Mandarin Speaking as this is required to cover East Asia market