Clinical Project Manager

Location
92130, San Diego
Posted
Nov 02, 2018
Discipline
Clinical
Required Education
Masters Degree/MBA
Position Type
Full time

Come join our world-class team evaluating, in-licensing and developing innovative therapeutic products internationally.

HUYA Bioscience International is a development-stage biopharmaceutical company bringing innovations from China to global markets in multiple therapeutic areas. HUYA’s lead compound in oncology, HBI-8000, is in late stage clinical development in Japan and Korea as monotherapy for the treatment of hematological malignancies. In the United States, HBI-8000 is being developed in combination with immune checkpoint inhibitors in solid tumors. The Company’s lead cardiovascular program, HBI-3000, is in Phase 1 in Europe. Two additional compounds are in early evaluation for oncology and cardiovascular diseases. More information can be found at www.huyabio.com

Job Summary

This position reports to the Vice President, Clinical Operations. The Clinical Project Manager (CPM) independently manages multiple clinical trials of moderate complexity. The CPM is expected to manage all sites and vendor (e.g. Clinical Research Organization) related issues, with supervision from the Vice President, Clinical Operations. Simultaneously, manages all aspects of multiple global clinical studies including timelines, budgets, and resources.

This is an office-based position that works in a cross-functional and dynamic environment.  Clear, timely, professional, and effective communication with all HUYA functional areas and global office sites is essential.

Primary Duties and Responsibilities

  • Manages study operational plan and CRO activities, including project timelines & quality of deliverables, and managing approved trial budget(s) throughout the life of the assigned clinical trial(s)
  • Participates in the selection of study vendors for assigned studies
  • Maintains frequent and meaningful contact with CROs to assess performance and provide guidance as needed
  • Reviews and refines clinical operational plans including the study monitoring plan and other plans as needed
  • Coordinates internal and external clinical development activities of all team members involved in the design and conduct of assigned clinical trials
  • Contributes to relevant study documentation including clinical protocols, statistical analysis plan, clinical study reports as well as operational plans (CMP, DMP)
  • Assists in the development and management of study timelines (including recruitment)
  • Participates in the selection of investigational sites with input from internal team and vendors
  • Assists with protocol design and medical issue resolution
  • Proactively helps to identify project risks and resolves with some supervision
  • Participates in study data review and other review activities as assigned
  • Oversees clinical trial sites’ adherence to pertinent regulations through review of monitoring reports, CQA-GCP audit report, communications with investigators, study site personnel, CRAs, and other CRO/designee personnel
  • Leads ongoing review of data to ensure GCP
  • Identifies and provides solutions to clinical trial issues and/or risks
  • Provide or facilitate training to clinical study teams and vendors on assigned protocol specific topics
  • Provide input into non-project related activities and development of department processes, procedures, and guidelines as requested

Job Qualifications and Requirements

  • Thorough understanding of FDA, ICH and GCP guidelines
  • Proven track record showing clear proficiency in clinical project management skills
  • Proven complex problem-solving skills
  • Solid vendor management skills, e.g. CRO, laboratory, and clinical supply logistics
  • Broad understanding of clinical operations related to clinical development functions
  • Detailed understanding of all aspects of clinical protocol design and implementation & overall drug development
  • Ability to effectively interface with medical personnel at clinical site(s)
  • Ability to write and edit technical documents, such as protocols, protocol amendments, informed consent, and other trial-related documents
  • Detail and team oriented with excellent cross-functional team leadership skills
  • Excellent interpersonal, verbal and written communication skills
  • Ability and willingness to travel internationally and domestically (minimal)

Education and Experience

  • BA, BS or Master’s Degree in life science, or related field (or equivalent experience)
  • Minimum of 8 years of clinical research experience, at least 2 of which are as a Project Manager for clinical studies at a CRO and/or pharmaceutical/biotech organization
  • Experience with Phase I – IV clinical trials
  • Proficiency with computer programs such as Microsoft Office suite and Microsoft Project

The position is full‐time and the candidate must be within commuting distance to HUYA’s Del Mar, CA headquarters.

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