Study Management
Forecast timelines, budget & FTE resource (if applicable).
Take a key leadership role in the management of studies’ timeline, quality, cost.
Ensure all activities must be in compliance with SOPs, applicable policies and related standards, and in line with GxP, local laws and regulations.
Monthly track and manage the agreed studies’ timelines, budget and resource, highlight significant variance and take appropriate actions to get studies on track.
Update study information into VCV, Evidence Connect system, Medical Tracking system, and update to global & regional team to ensure up-to-date information captured.
Timely update project information to the Brand Team.
Review and approve project relevant documents.
Lead preparation and delivery of study documents (e.g. Protocols/amendments, ICF, CRF, studies’ related plans and forms, etc.)
Prepare and lead investigator and monitor meeting.
Ensure AEs/SAE reporting according to GCP and regulation.
Plan and lead activities associated with study level Quality Control plan.
Develop & manage contingency risk plans to assure timely delivery to quality, budget, and time and escalate issues to stakeholders as appropriate.
Provide operational support to the ESR investigators to ensure the on time delivery of ESR Compliance with Parexel standards.

Minimum 2–3-year experience of project management experience
Prior experience not only as a clinical management staff, but responsible for training/ quality assurance/quality control/ procedural document development
Read, write, and speak fluent English; fluent in host country language required.
Advanced level project delivery skills, including experience of study start up, ongoing phase and study close out
Strong interpersonal skills, with the ability to work effectively with others at all levels of the organization
Excellent process, SOP, GCP and company policy competency, and drug regulations
Good computer skills in Microsoft and other software.
Proven ability to deliver training

Comply with required training curriculum
Complete timesheets accurately as required
Submit expense reports as required
Update CV as required
Maintain a working knowledge of and comply with Parexel processes, ICHGCPs and other applicable requirements.

Clinical Project Manager – FSP

Key skills