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Project Manager - EP

extra holidays - extra parental leave - fully flexible
Remote: 
Full Remote
Contract: 
Full time
Work from: 
China, Australia

Offer summary

Qualifications:

University degree or equivalent, Experience in project management, Knowledge of ICH/GCP regulations, Scientific/Medical/Pharmacology background is an advantage.

Key responsabilities:

  • Manage Phase I and II projects
  • Communicate with sponsors and vendors
Parexel logo
Parexel XLarge http://www.parexel.com
10001 Employees
About Parexel
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
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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.

***Mandarin language is requested.

Job Purpose: 

  • Project Manager for Phase I and II studies

Key Accountabilities:

  • Initiate, plan, manage and close out of Phase I and II projects with all departments in Parexel including external vendors and Early Phase partner sites.
  • Project communication with sponsor, Parexel team and external vendors
  • Continuous reporting and update of project progress including communication internally and with sponsor and external vendors as needed.
  • Organizing and supporting the submission of Early Phase studies to the China regulatory authority and local Ethics Committee according to ICH-GCP timelines.
  • Budget control for Phase I and II studies including:
  • Service inquiries with external vendors
  • Budget and contract negotiation with sponsors and external vendors
  • Forecasting, tracking and invoicing
  • Responsible for core team meetings with sponsor, Parexel team and external vendors.
  • Routine filing of essential documents and quality control checks of the Trail Master File.
  • Compiling and maintaining study documents such as the project plan.
  • Support setup of project specific training in Parexel system.

Skills:

  • Knowledge in the field of clinical studies
  • Organizational talent
  • Very good knowledge in English(spoken and written command) and Chinese
  • Ability to work under pressure
  • Solid computer and internet skills (e.g. MS-Office, Excel, PowerPoint and MS Project)

Knowledge and Experience:

  • Relevant experience in project management in a research institute or pharmaceutical industry
  • Knowledge of regulations according to ICH/GCP and applicable local regulations
  • Budget / Contract experience desirable

Education:

  • University degree or equivalent
  • Scientific/Medical/Pharmacology background an advantage

Required profile

Experience

Spoken language(s):
English
Check out the description to know which languages are mandatory.

Hard Skills

Project ManagementClinical TrialsBudget ManagementRegulatory ComplianceMicrosoft ProjectPharmacy ExperienceContract Negotiation

Other Skills

  • Microsoft Office
  • Organizational Skills
  • Communication
  • Calmness Under Pressure
  • Computer Literacy
Are you interested?

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