Clinical Program Manager (Fibrosis) (11-116) FibroGen

Description:
FibroGen seeks a seasoned Clinical Program Manager (CPM) to manage multiple clinical trials. The successful candidate will possess previous experience as a CPM managing more than one trial. Global/Asia trial experience is highly desirable. In addition, we seek a demonstrated stellar track record in the oversight of all trial operational aspects including: budgets, timelines, resources, vendor selection and oversight of clinical team staff during study start-up, interim monitoring and closeout activities. Prior experience with direct report management is required as is prior therapeutic experience for Hepatitis/GI. This position reports to a Director, Clinical Operations on the Fibrosis team.
Responsibilities:

Manage a current Hong Kong trial in HBV that may expand into other countries
Manage potential HCV trial
Manage clinical study teams, CROs and Vendors to ensure that the study(ies) are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines

Job Requirements:

Bachelor's degree in a relevant scientific discipline or equivalent
At least 8 years of relevant clinical experience in the pharmaceutical industry or equivalent with 4+ years as a CRA in biotech or Pharmaceutical clinical operations environment, and 1 year prior experience as a CPM preferred
2+ years managing staff / direct reports
Experience with Hepatitis and/or GI trials required
Knowledge of GCP and ICH guidelines required
Proficiency in the implementation, monitoring, and management of clinical trials
Excellent communication and interpersonal skills
High level of attention to detail and ability to thrive in a flexible, fast paced environment
Able to problem solve and use good judgment
Able to work collegially within a team and carry out duties/responsibilities with general instructions
Proficiency with MS Word, Excel, Outlook, PowerPoint and Microsoft Project
Must be willing to travel as required for the project (approx. 10 25 ) including Asia region

Location:	San Francisco, CA United States