[Hiring] Clinical Project Manager @Parexel

Role Description

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Key Accountabilities:

• 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 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.

Qualifications

• 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.

Requirements

• 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.