Clinical Project Manager/ Sr. Clinical Project Manager

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PRIMARY DUTIES:

  • Management of clinical research project
  • Vendor (CRO, Lab, drug storage, etc.) supervision and management
  • Liaison with KOLs
  • Support IND and NDA filing
  • Quality control of the clinical research projects, such as co-monitoring

 

RESPONSIBILITIES:

  • Adhere to corporate SOPs and local WIs in the planning, conduct and reporting of clinical trials.
  • Provide leadership in the conduct of clinical trials, protocol implementation, data analysis, management of project progress and timelines.
  • Input operational part of the protocol for trials.
  • Review and approve study CRFs.
  • Prepare Monitoring Manual and ensure it is in agreement with the protocol and SOP.
  • Contact with CMC department regarding design of labeling, packaging and drug logistics.
  • Train, counsel and guide CRAs involved in a trial on the trial requirements, procedures, monitoring standards, reporting and current issues. Records of training should be maintained.
  • Select clinical trial site and keep good relationship with investigators.
  • Initiate and ensure timely submission to IRB/IEC and support investigator as necessary.
  • Support contract negotiation with study sites.
  • Select and cooperate with statistician to conduct data analysis when required.
  • Participate in regular Data Quality Review Meetings.
  • Coordinate final trial report.
  • Support CRO Selection.
  • CRO supervision at the trial level.
  • Support IND and NDA filing: Document review and progress tracking.
  • Do co-monitoring visits for the project.
  • Review monitoring reports.
  • Check TMF before archiving.

 

QUALIFICATIONS:

  • At least bachelor degree in pharmacy, biochemistry or related major. Mater degree is preferred.
  • 5-8 years industry experience with proven proficiency in clinical research management for drug development.
  • Good understanding of ICH guidelines, GCP and regulatory requirements.
  • Excellent planning, organization and problem solving abilities.
  • Good communication and interpersonal skills.
  • Proficiency in English and familiarity with standard IT office tools.