CIinicaI Project Manager

Website InnoCare Pharma Inc. (US)

 

InnoCare Pharma is a clinical-stage biopharmaceutical company dedicated to discovering, developing, and commercializing best-in-class and/or first-in-class drugs for the treatment of cancer and autoimmune diseases.

InnoCare has strong in-house innovation capabilities, holding multiple foreign and domestic patents with a rich product pipeline target liquid tumors, solid tumors, and autoimmune diseases. Our team has discovered and developed our current pipeline of over 10 novel drug candidates, including our core product candidate Orelabrutinib, whose NDA was accepted and granted priority review by the NMPA earlier this year.

InnoCare was co-founded by Professor Shi Yigong, a world-renowned structural biologist, and Dr. Cui Jisong, an outstanding leader in the biopharmaceutical industry. We have nearly 300 employees, including over 100 researchers. Our core R&D staff brings rich experience from the world’s top pharmaceutical companies, such as Pfizer, Bristol-Myers Squibb, Merck, Johnson & Johnson, Bayer, etc. We are a truly global biopharmaceutical company with sites in Beijing, Nanjing, Shanghai, and Guangzhou, in addition to branches in New Jersey and Boston for US development and clinical management.

On March 23, 2020, InnoCare was officially listed on the Hong Kong Stock Exchange (code: 9969). Our vision is to become a world-class leader in innovative medicine and lead China’s medicinal research into a new era.

 

CIinicaI Project Manager

JOB TYPE: Full-time

LOCATION: New Jersey, US

 

Responsibilities:

  1. Management of regional/global multi-center oncology or autoimmune clinical studies.
  2. In collaboration with Project Director, defines, develops, and sets project timelines, budget, necessary procedures, staffing requirements, and resources.
  3. Oversight of clinical studies, interacting with CRO, study vendors, and the Investigators to ensure goals and objectives are accomplished within projected timeframes and budget requirements.
  4. Ensures efficient streamlined processes are in place to deliver study to plan and ensure the safety of patients and completeness/integrity of data.
  5. Ensures development, review, finalization, and delivery of high-quality key clinical study documents to meet the study timelines.
  6. Accountable for study-related communications and for resolution or escalation of operational issues with all related project members and departments.
  7. Reviews status reports and modifies project schedules and/or plans as required.
  8. Organizes and leads internal project meetings and participates in Investigator’s Meetings.
  9. Performs monitoring visits as needed (e.g. Quality assurance, audit preparation, etc.)
  10. Prepares and presents project reports for management or others.
  11. Ensures adherence to Good Clinical Practice and all applicable local and international regulations.

 

Requirements and skills:

  1. Educated to degree level (biological sciences, pharmacy, or other health-related discipline preferred) or relevant experience in a medical/nursing field.
  2. At least 3 years of experience as a Clinical Project Manager.
  3. Preferred experience in Oncology or autoimmune diseases.
  4. Experience in monitoring clinical trials to ICH/GCP.
  5. Excellent interpersonal, verbal, and written communication skills (in English).
  6. Ability to motivate both individually and collectively.
  7. Excellent problem-solving capability through early identification.
  8. Excellent computer literacy.
  9. Travel may be required.
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