Clinical Project Manager _ HQ taipei

1 week ago

Taipei City, Taiwan PharmaEssentia Corp. Full time NT$180,000 - NT$240,000 per year

About the job

PharmaEssentia Corp, is a Taiwan-based, full-spectrum biopharmaceutical company specializing in the innovation, clinical development, manufacturing, and global marketing of new drugs. Leveraging its deep expertise and core R&D capabilities, PharmaEssentia is committed to providing advanced treatment options in hematology and oncology, with self-developed product currently on the market and a continually expanding product portfolio.

We are seeking a highly experienced and motivated Global Project Manager to lead biopharmaceutical clinical trials from a sponsor's perspective. This role is responsible for strategic planning and execution across global clinical projects, ensuring high-quality and timely study conduction.

Responsibilities:

  • Serves as global level project manager from sponsor end (perform and participate in project development process and CRO and vendors selection, review core document/procedure, etc.)
  • Meet country goals through project strategy planning/execution in collaboration with project members.
  • Ensure study conduction with speedy and good quality through project leadership with internal cross functional teams, CRO Oversight, Issue management, CRO oversight monitoring visit and etc.
  • Initiates and maintains relationships with Investigator according to assigned therapeutic area.
  • Support and lead country activity to enhance cross-functional department cooperation according to assignments.
  • Perform other duties as assigned.

Qualification

  • Minimum of 15 years of experience clinical trial, with specific experience in project management, audit readiness and regulatory submissions for biologics products.
  • Global Clinical Trial experience
  • Strong knowledge of GCP regulations and guidelines, including FDA and ICH requirements.
  • Experience with IND submissions and regulatory interactions with FDA or other regulatory agencies.
  • Strong analytical and problem-solving skills, with the ability to identify compliance issues and propose effective solutions.
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
  • Ability to work independently and prioritize tasks in a fast-paced environment.

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