|
 |
Clinical Program Manager/Sr Clinical Program Manager (Fibrosis)
(Job Code: 8HR144)
FibroGen seeks a Clinical Program Manager / Sr Clinical Program Manager
for our Connective Tissue Growth Factor (CTGF) Fibrosis Program, to
manage trials for subjects with diabetic nephropathy and chronic kidney
disease who will enroll into our developing FGCL-3019 (monoclonal
antibody) program. Reporting to an Associate Director, specific
responsibilities include:
Manage clinical studies to ensure that they are completed on time,
within budget, and in compliance with SOPs, FDA regulations and ICH/GCP
guidelines
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.
Responsible for clinical site budget development
Responsible for CRO selection and assist in the development of RFPs.
Manage the Contract Research Organizations (CROs) responsible for the
conduct of clinical studies
Manage the activities of vendors, including clinical services, data
management, biostatistical services, and central laboratory services
Manage clinical personnel, including in-house and contract Clinical
Research Associates (CRA)
May be responsible for ensuring SOP and regulatory compliance of staff
Assists in CRO selection, development of RFPs, budget negotiations,
and provides CRO management overall.
Assists in the development and writing of study protocols, study
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.
Mentor and develop junior staff. May manage and direct junior staff
Estimate and manage the clinical supplies needed for the conduct of
clinical trials
Develop clinical monitoring plans and establish study monitoring
priorities
Address and seek resolution of administrative issues with
investigational sites and/or CROs
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.
Proficiency in the implementation, monitoring, and management of
clinical trials
Demonstrated managerial and supervisory skills
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. Microsoft
Project skills preferred.
Must be willing to travel as required for the project (approx. 10%)
|
| |
