Clinical Project Manager (FSP)

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

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Forecast timelines, budget & FTE resource ( if applicable).

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Take a key leadership role in the management of studies’ timeline, quality, cost.

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Ensures all activities must be in compliance with SOPs, applicable policies and related standards, and in line with GxP, local laws and regulations.

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Monthly track and manage the agreed studies’ timelines, budget and resource, highlight significant variance and take appropriate actions to get studies on track.

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Update study information into VCV, Evidence Connect system, Medical Tracking system, and update to global & regional team to ensure up-to-date information captured .

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Timely update projects information to the Brand Team.

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Review and approve project relevant documents.

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Lead preparation and delivery of study documents (e.g. Protocols/amendments, ICF, CRF, studies’ related plans and forms, etc.)

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Prepare and lead investigator and monitor meeting.

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Ensure AEs/SAE reporting according to GCP and regulation.

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Plan and lead activities associated with study level Quality Control plan.

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Develop & manage contingency risk plans to assure timely delivery to quality, budget, and time and escalate issues to stakeholders as appropriate.

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Provide operational support to the ESR investigators to ensure the on time delivery of ESR

Compliance with Parexel standards

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Comply with required training curriculum.

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Complete timesheets accurately as required.

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Submit expense reports as required.

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Update CV as required.

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Maintain a working knowledge of and comply with Parexel processes, ICHGCPs and other applicable requirements.

Skills :

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Advanced level project delivery skills, including experience of study start up, ongoing phase and study close out

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Strong interpersonal skills, with the ability to work effectively with others at all levels of the organization

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Leadership skills

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Excellent process, SOP, GCP and company policy competency, and drug regulations • Good computer skills in Microsoft and other software.

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Fluent in both oral and written English

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Proven ability to deliver training

Knowledge and Experience :

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Minimum 2–3-year experience of project management experience.

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Prior experience not only as a clinical management staff, but responsible for training/ quality assurance/quality control/ procedural document development

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Read, write, and speak fluent English; fluent in host country language required.

Education :

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