Offer summary

Qualifications:

Bachelor’s or higher degree in Science, Medical, or Pharmaceutical fields., Minimum of 2-3 years of project management experience., Strong understanding of GCP, SOPs, and drug regulations., Excellent communication and leadership skills, fluent in English..

Key responsibilities:

Manage study timelines, budgets, and resources.

Lead preparation and review of study documents and meetings.

Ensure compliance with GCP, SOPs, and local regulations.

Provide operational support and training to study teams.

Job 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.

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

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