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Clinical Program Manager/Sr Clinical Program Manager (Anemia)
(Job Code: 7HR213)
FibroGen seeks Clinical Program Manager / Sr Clinical Program Manager
for our Anemia Program, trials for subjects with anemia and chronic
kidney disease who are on hemodialysis for our FG-2216 program.
Reporting to an Associate Director, specific responsibilities include:
Manage study activities, including investigator recruitment and
selection, study start-up, enrollment, data collection, drug
projections, and reports.
Manage study sites and train clinical site staff to ensure protocol and
regulatory compliance.
May be responsible for ensuring SOP and regulatory compliance of staff.
Responsible for CRO selection, development of RFPs, budget
negotiations, and CRO management.
Responsible for clinical site budget and contract negotiation.
Responsible for writing study protocols, monitoring plans, study
reports, sections for Investigator's Brochures, and regulatory
documents (e.g., IND, NDA or BLA). Interact with investigators and
thought leaders for protocol development, presentations and publications.
Coordinate and participate in investigator meetings.
Manage program budget and timelines.
Mentor and develop junior staff.
Requirements:
Bachelor's degree in a relevant scientific discipline or equivalent.
8+ years of relevant clinical experience in the pharmaceutical industry
or equivalent.
Knowledge of GCP and ICH guidelines required.
Excellent communication and interpersonal skills. Detail oriented.
Able to problem solve and use good judgment.
Able to work within a team. And work with general instructions.
Proficiency with MS Word, Excel, Outlook, and PowerPoint.
Must be willing to travel as required for the project.
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