Pre/Post PSV Administrator

Pre/Post PSV Administrator is responsible for all activities leading up to site selection, which requires significant contributions from the team. As we continue to grow, we have recognized the increasing need for thorough preparation and execution throughout the PSV cycle. This process involves coordinating multiple deliverables and ensuring the timely completion of a wide range of documents.

DUTIES & RESPONSIBILITIES

Document Collection & Tracking

• Gather all required documents (protocol, feasibility questionnaire, CDA, investigator brochure, regulatory templates, etc.).
• Maintain a checklist to track completion and status of required materials.

File Organization

• Ensure all documents are filed correctly in the central system (SharePoint, eTMF, or tracker).
• Use standardized naming conventions and version control to avoid confusion.

Scheduling & logistics

• Coordinate PSV dates with sites, BD, and Clinical Ops.
• Send out PSV invites and circulate agendas in advance.

Document Finalization

• Collect completed PSV reports, meeting notes, and any updated forms.
• File documents in the appropriate system, ensuring compliance and audit readiness.

Action Item Tracking

• Update trackers with PSV outcomes, pending site requests, or missing documents.
• Follow up with responsible team members to ensure timely completion.

Communication Support

• Distribute PSV summary or next steps to the broader team.
• Assist BD/Clinical Ops in preparing documentation for final site selection decisions.

Project Management

• Track timelines for all PSV activities.
• Maintain a central tracker/dashboard for documents, site contacts, and status updates.
• Facilitate cross-functional coordination and ensure accountability for deliverables.

KNOWLEDGE & EXPERIENCE

Education:

• N/A

Experience:

• Minimum of 1 years of relevant experience in business analysis, preferably within the clinical research or healthcare industry.

Credentials:

• N/A

Knowledge and Skills:

• Excellent analytical and problem-solving skills, with the ability to manage multiple projects in a fast-paced environment.
• Strong communication and presentation skills, with the capability to articulate complex data insights to nontechnical stakeholders.
• Proven leadership abilities and a proactive, self-driven work ethic.
• Familiarity with regulatory standards and quality assurance processes in clinical research is highly desirable.