New Beta Innovation Limited

Senior/ Clinical Project Manager

New Beta Innovation Limited
Kowloon Bay
Posted on 20-Sep-21

Senior/ Clinical Project Manager

New Beta Innovation Limited

Job Highlights

  • Working station nearly Kowloon Bay MTR
  • Professional job in a biopharmaceutical firm
  • Challenging job

Job Description

The Job:
  • Management of all aspects of Clinical Project Team activities for assigned projects
  • In concert with the Clinical Project General Manager, accountable for achieving successful delivery of clinical team activities at the project level by meeting company and regulatory requirements according to time, quality/scope and budget constraints
  • Proactively manage project level operational aspects of the assigned clinical trials including management of trial timeline, budget, resources and vendors
  • Lead vendor identification and selection processes with cross functions
  • Lead study startup process, including but not limited to study documents production, contract and budget review and negotiations, conduct of kick-off meeting, investigator meeting, site initiation meeting, set-up of trial master file
  • Ensure effective project plans such as project management, safety management, data management, monitoring, electronic data capture platform, etc. are in place prior to the kick start of trials, including but not limited to the write-up, review and approval of such plans in accordance with company SOPs, ICH GCP guidelines and regulatory requirements
  • Review and approve clinical trial monitoring reports; ensure tracking, follow-up and resolution to site/vendor issues have been completed in a timely manner
  • Monitor the quality of vendor deliverables, address quality issues with the appropriate team member
  • Ensure all project level study documentation is filed in the project file and provide oversight to the vendor regarding TMF filing and maintenance in lieu of inspection readiness
  • Work with vendor to assist in the development of the clinical quality management system including but not limiting to review and write-up of standard operating procedures
  • Work with vendors to assist in the development of safety database and product safety profile during the drug development cycle
  • Willing to travel to Mainland China to lead the development, submission and execution of clinical trials in China
  • Coach junior staff and other duties as assigned
 The Person:
  • Master degree or above in Life Sciences or related disciplines
  • Thorough understanding of drug development cycle, applicable clinical research requirements such as Good Clinical Practice, and related ICH Guidelines
  • Five or more years of clinical research experience at the level of pharmaceutical or CRO industry is required
  • Three or more years of clinical project management experience mastering clinical trial activities
  • Independent, good communication and organizational skills, strong sense of team spirit and able to work under pressure
  • IT literacy in Word, Excel and Powerpoint
  • Proficiency in both written and spoken Chinese and English are mandatory, with Putonghua and simplified Chinese an asset
  • Therapeutic experience in oncology, cadiovascular and early phase trials preferred
We offer 5-day work week, attractive remuneration and benefits, comprehensive training and career development opportunities to the qualified candidates. Interested parties please send your application with full resume including your present and expected salary to the Company. 
  • Mail: Human Resources Department, New Beta Innovation Limited, 18 Chevalier Commercial Centre, 8 Wang Hoi Road, Kowloon Bay, Kowloon, Hong Kong

Additional Information

Career Level
Middle
Qualification
Postgraduate
Years of Experience
5 years
Job Type
Full Time, Permanent

Company Overview

Here's your chance to join a dynamic and fast-growing life sciences company in Hong Kong.

New Beta Innovation Limited is dedicated to discovery and development of advanced life-saving hemoglobin-based therapeutics for the well-being of people.

Leveraging on our expertise in research and development, we have been transforming drug discovery into clinical applications for unmet medical needs.

We have collaborations with top universities worldwide on research projects with strong focus on innovating health solutions for critical clinical conditions and diseases.

Headquartered in Hong Kong, we have research laboratories, manufacturing facilities and offices located in Hong Kong, China, Canada and New Zealand.

We believe a dedicated, talented and quality work force is a vital asset to the Company and fundamental to our success. We are constantly seeking qualified members to join our family.

Additional Company Information

Industry
Medical/Pharmaceutical
Benefits & Others
Medical insurance, Performance bonus, Five-day work week