Clinical Operations Manager
4000 Shoreline Court, Suite 250 South San Francisco, CA 94080
Clinical Operations Manager
We are seeking an experienced candidate at the Clinical Operations Manager level as part of the critical functions in transitioning Harpoon Therapeutics to a clinical stage company. This position reports to the Sr. Director, Clinical Operations.
Responsible for the planning, successful implementation and management of one or multiple clinical trial(s) that includes: Identifying, soliciting proposals and reviewing bids from CROs, negotiating contracts with CROs, study sites and clinical trial vendors as well as managing the recruitment, execution and completion of clinical trial(s). This role will also include the development of study protocols, case report forms, clinical reports, performing site monitoring visits, and interfacing with site coordinators, field clinical staff, CROs and other company representatives. Provide leadership with regards to the overall strategic planning and successful implementation of one or multiple clinical development programs. Maintain high level relationships across all functional areas that interact with Clinical Operations (including Product Development, Research, Translational Medicine, etc.). Additional responsibilities may include strategic project management of company’ s product development.
- Maintain and/or accelerate timelines for achieving clinical operational milestones
- Ensure that documentation from investigators and investigational sites meets FDA/GCP/ICH requirements
- Design, plan, and implement clinical research projects through the approval process including, but not limited to the design of study protocol(s), case report forms, informed consent(s), study manuals, etc.
- Review study records including case report forms, consent forms and other materials; perform site visits to ensure regulatory and study requirements are being fulfilled
- Analyze data based on study results, interpreting research information and creating detailed documentation; Organize data in systematic manner to allow for efficient and accurate clinical reports
- Train and assist site coordinators, investigators, field clinical staff, CRO (as applicable) in collecting data in a timely manner that meets the protocol requirements and timelines/milestones; serve as a resource to site coordinators, investigators and other staff members regarding investigational products and protocols; monitor and track progress and obstacles and responding to day-to-day problems
- Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures
- Assist in identification and hiring of appropriate CROs and third party study vendors. Oversee performance of CROs, third party vendors, and field CRAs including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identifying areas of concern and escalating to the Sr. Director, Clinical Operations.
- Assist in preparation, negotiation and management of and adherence to study budgets; perform initial review of CRO and vendor invoices
- Develop and implement enrollment strategies
- Assist in writing the clinical portion of Regulatory submissions
- Compile and maintain regular status reports of study progress and study specific timelines and ensure information is provided to Management
- Direct development of SOPs within department and participates in development of collaborative SOP development; oversees adherence to SOPs
- Mentor junior staff in acceptable clinical practices, conducting performance reviews, participating in hiring activities, etc
- Perform other duties as requested
- Bachelor’ s degree in a scientific or health care discipline preferred and/or training or equivalent combination of education and experience. Advanced degree(s) in scientific research, medicine, nursing, law, or business is preferred
- 5-10 years experience in oncology and/or orphan drug development strongly preferred
- 5+ years experience in the role of Clinical Research Associate preferred
- 2-3 years of successful, wide-ranging experience managing CRO’ s and study sites from study start-up through study maintenance and close out, with a demonstrated understanding of the data management components needed in a trial, enrollment projections, management and strategies
- Extensive experience in the preparation, monitoring, and execution of clinical studies
- Demonstrated ability to motivate clinical site personnel to maintain and/or accelerate timelines in order to achieve clinical operational milestones
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
- Excellent understanding and demonstrated application of Good Clinical Practices (GCP) and ICH Guidelines. Able to comply with safety standards and respect privacy and confidentiality
- Superb verbal and written communication skills
- Excellent organizational skills along with strong attention to detail
- Ability to work both independently and collaboratively with cross-functional teams
- Ability to utilize critical thinking to analyze problems which may require multiple factors and approaches
- Some domestic and international travel would be required for site training, monitoring responsibilities, etc. Ability to travel approximately 20%.