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Location
ボストン
Salary
Competitive Salary
Job Type
Permanent
Ref
BH-173605
Contact
Richard Hao
Contact email
Email Richard
Posted
約2ヶ月前
  • Well-known Listed Pharmaceutical Group, global business is rapidly expanding
  • Dynamic international working environment, bottom-up culture
  • A fast-moving opportunity on career path and fair internal promotion mechanism

The Role:

Our client is a world leading listed pharmaceutical group, CRO is their innovation business worldwide. They are proud of the strides that we have made since our founding in 1999, providing R&D and one-stop production services to the world’s top pharmaceutical companies. Driving our success is our commitment to continual optimization and investing in the future. By improving the capabilities our partners need now, and maintaining the agility needed to support innovation, we’ve built a knowledge and experience base that we’re ready to share.

Whether we’re supporting emerging biotech companies or smaller, specialty pharma, our mission remains to accelerate the launch of new drugs, providing one-stop CMC services for the full lifecycle of drug development.

Requirements

Line Manager: US head and dotted line to Function Leader

Job Responsibility Summary
  • Responsible for the management and performance of clinical studies from sponsors. In accordance with the ICH-GCP and other relevant laws, regulations and technical guidelines and company SOPs for the conduct of the project from feasibility, startup, monitoring, and close out etc. Ensure that the project is performed under timeline, budget and in high quality standard.
  • Participate in business development technical support related work.
Job Responsibilities
  • Proactively manage project level operational aspects of Clinical Trial Team (CTT) including management of trial timeline, budget, resources and vendors.
  • Provide efficient updates on trial progress to the Clinical Operation Director (COD) and/or Head of Clinical Operation (CO) US, with respect to vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation.
  • Ensure effective study plans are in place and operational for each assigned trial and work proactively with the Clinical Team in accordance with applicable project plans, company SOPs, ICH/GCP guidelines and regulatory requirements as applicable.
  • Ensure potential study risks are escalated to the attention of the COD and Head of CO US when appropriate.
  • Chair Clinical Team meeting and vendor status update meetings and ensure meeting minutes are completed, distributed to team members and filed in the Trial Master File (TMF) in a timely manner.
  • Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team.
  • Review and approve vendor invoices in collaboration with the Accounting team to ensure investigator payments occur in a timely manner.
  • Review and approve vendor responses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and regulatory requirements.
Job Requirements

Education/Experience

  • Bachelor or advanced degree in Life Sciences.
  • Eight or more years of clinical operations experience for CPM; with increasing levels of responsibility, in the Pharmaceutical, Biotechnology, Medical Device or CRO industry is required.
  • Experience in early phase trials as a plus.
Skills
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.
  • Strong communication, presentation and interpersonal skills.
  • Robust and current knowledge of scientific, clinical, regulatory, commercial and competitive landscape in applicable therapeutic area.
  • Proven skills in providing consultation and advice on multiple assignments are required, as well as initiative and flexibility. 

BeathChapman Pte Ltd