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 <ul><li>Forecast timelines, budget & FTE resource ( if applicable). </li></ul><ul><li>Take a key leadership role in the management of studies’ timeline, quality, cost. </li></ul><ul><li>Ensures all activities must be in compliance with SOPs, applicable policies and related standards, and in line with GxP, local laws and regulations. </li></ul><ul><li>Monthly track and manage the agreed studies’ timelines, budget and resource, highlight significant variance and take appropriate actions to get studies on track. </li></ul><ul><li>Update study information into VCV, Evidence Connect system, Medical Tracking system, and update to global & regional team to ensure up-to-date information captured . </li></ul><ul><li> Timely update projects information to the Brand Team. </li></ul><ul><li>Review and approve project relevant documents. </li></ul><ul><li>Lead preparation and delivery of study documents (e.g. Protocols/amendments, ICF, CRF, studies’ related plans and forms, etc.) </li></ul><ul><li>Prepare and lead investigator and monitor meeting. </li></ul><ul><li>Ensure AEs/SAE reporting according to GCP and regulation. </li></ul><ul><li>Plan and lead activities associated with study level Quality Control plan. </li></ul><ul><li>Develop & manage contingency risk plans to assure timely delivery to quality, budget, and time and escalate issues to stakeholders as appropriate. </li></ul><ul><li>Provide operational support to the ESR investigators to ensure the on time delivery of ESR </li></ul> Compliance with Parexel standards <ul><li>Comply with required training curriculum. </li></ul><ul><li>Complete timesheets accurately as required. </li></ul><ul><li> Submit expense reports as required. </li></ul><ul><li>Update CV as required. </li></ul><ul><li>Maintain a working knowledge of and comply with Parexel processes, ICHGCPs and other applicable requirements. </li></ul>Skills: <ul><li>Advanced level project delivery skills, including experience of study start up, ongoing phase and study close out </li></ul><ul><li>Strong interpersonal skills, with the ability to work effectively with others at all levels of the organization </li></ul><ul><li>Leadership skills </li></ul><ul><li>Excellent process, SOP, GCP and company policy competency, and drug regulations • Good computer skills in Microsoft and other software. </li></ul><ul><li>Fluent in both oral and written English </li></ul><ul><li>Proven ability to deliver training </li></ul> Knowledge and Experience: <ul><li>Minimum 2–3-year experience of project management experience. </li></ul><ul><li>Prior experience not only as a clinical management staff, but responsible for training/ quality assurance/quality control/ procedural document development </li></ul><ul><li>Read, write, and speak fluent English; fluent in host country language required. </li></ul> Education: <ul><li>Bachelor’s or higher degree in Science, Medical or Pharmaceutical Background </li></ul>

Clinical Project Manager (FSP)

Description

Parexel