Job Location

San Francisco Bay Area site

Job Description

Fochon is currently seeking a highly motivated and energetic clinical program manager. The successful candidate will be responsible for the planning, management, execution and completion of Fochon’s clinical programs. This includes the management of CROs, vendors, and clinical sites to ensure timelines, goals, and objectives are met. This position will be based in the San Leandro, CA officeFochon is currently seeking a highly motivated and energetic clinical program manager. The successful candidate will be responsible for the planning, management, execution and completion of Fochon’s clinical programs. This includes the management of CROs, vendors, and clinical sites to ensure timelines, goals, and objectives are met. This position will be based in the San Leandro, CA office.

Responsibilities

• Oversees clinical activities, from study and site start-up through completion of clinical trials.
• Manages CRO, vendor and clinical sites activities, and tracks internal and external project deliverables to ensure all activities necessary for study start through study completion remain within the timeline and budget
• Creates, review and/or approves documents and procedures required to conduct clinical studies, including, but not limited to, protocols, informed consent forms, investigator brochures, case report forms, study procedure manuals.
• Create and implement departmental procedures (including project management processes and SOPs) in compliance with industry standards and regulatory requirements.
• Participates in and leads process improvement activities within the department and cross functionally teams of medical affairs, data management, logistics, etc.

Requirements

• Master’s degree required (scientific or healthcare discipline preferred).
• Minimum 5 years previous experience in clinical research and development in biopharmaceutical or CRO environment.
• In-depth working knowledge of FDA regulations and ICH GCP guidelines is required.
• Prior experience in oncology preferred.
• Ability to independently access relevant literature, analyze and write clinical-related documents, etc.
• Ability to deal with time demands, incomplete information or unexpected events.
• Must display strong execution and problem-solving ability.
• Excellent written and verbal skills required.
• Flexibility to travel as projects needed.
• Fluent in English and Chinese.

Fochon offers competitive salary and comprehensive benefits. Fochon is an equal opportunity employer. Please send cover letter and resume to slin@fochonpharma.com