Description
The Study Process Lead (SPL) oversees the execution of processes supporting clinical projects and research studies in accordance with global and local regulations.
The SPL collaborates closely with operational staff and the management team, serving as a key member of a team of Centralized Administrative Services supporting a single Sponsor.
The SPL manages operational elements of processes supporting clinical projects to deliver contracted clinical services to client satisfaction, having ownership of the process and serving as the point of contact for client-facing activities.
The SPL ensures that all documentation complies with expected quality, correct artifact, metadata, and location in accordance with customer internal conventions, SOPs, and WIs.
The SPL oversees, leads, and assures the quality in the update of clinical/regulatory databases such as CTMS, RDMS, and Clinical dashboards.
Essential Functions:
- Fully own the assigned processes from process creation and continuously through process execution and improvement.
- Act as a leader of tasks under assigned processes, ensuring correct scope definition, appropriate resourcing, and effective workforce organization.
- Perform close oversight of task progress and completion within defined delivery deadlines.
- Provide ongoing support to CPC/CPA during task completion.
- Provide on-demand training and create relevant guidance materials for task completion.
- Escalate performance issues and/or deliveries at risk to the LM team.
- Effectively communicate with the Client, other SPLs, CPCs/CPAs, and the LM team on process performance, escalations, identified issues, and process improvement proposals.
Minimum Requirements:
- Minimum 3-4 years of experience in the clinical trial industry.
- Excellent command of English language.
- Excellent command of Microsoft Office.
- Working knowledge of Project Management principles.
- At least 2 years of experience with Clinical Trial Management systems (CTMS) and/or eTMF.
- Previous experience as Senior Clinical Trial Assistant/Project Support Coordinator/Senior eTMF File reviewer, or Project Management Analyst/Project Support Coordinator with minimum 1 year of experience in the role.