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.
- 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.
- 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
- 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
