Clinical Project Manager (FSP)

Key Accountabilities:

Study Management

• Forecast timelines, budget & FTE resource ( if applicable).
• Take a key leadership role in the management of studies’ timeline, quality, cost.
• Ensures 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 projects 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

• 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.

Skills:

• 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
• Leadership skills
• Excellent process, SOP, GCP and company policy competency, and drug regulations • Good computer skills in Microsoft and other software.
• Fluent in both oral and written English
• Proven ability to deliver training

 Knowledge and Experience:

• 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.

Education:

• Bachelor’s or higher degree in Science, Medical or Pharmaceutical Background