Senior Clinical Trial Manager
Role and Responsibilities
· Manage the operational aspects of clinical trials
· Manage contract organizations and external vendors
· Day-to-day management of CRO and assigned vendors to ensure that project goals are achieved; organize and lead teleconferences with vendors, facilitate vendor activities and oversee adherence to scope of work and budget
· Manage clinical project plan, including timeline, budget and resources
· Lead defined aspects of clinical trials to ensure trials are initiated efficiently and completed on time, within budget and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines
· Work with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines and ensure that performance expectations are met
· Coordinate and be responsible for the design of study materials such as CRFs, CRF completion Guidelines, diaries, Monitoring plan, laboratory manual, pharmacy manual
· Participate in protocol development, Clinical Study report preparation, Data review committee as appropriate
· Prepare metrics and updates for management as assigned
· Review Informed Consent Forms and study related materials
· Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols
· Assist and support data query process
· Participate in the development, review and implementation of departmental SOPs and processes
· Recommend and implement innovative process ideas to impact clinical trials management
· Organize and manage internal team meetings, Investigator meetings and other trial-specific meetings
· Proactively identify potential study issues/risks and recommend/implement solutions
· Participate in CRO and vendor selection; develop RFPs for study vendors, review proposals and make CRO and vendor selection recommendations in collaboration with the Study team
· Ensure electronic trial master file is current and maintained
· Review CRO monitoring reports and ensure completion of action items. Escalate unresolved issues.
· Assist with training vendors and team members on study protocol and processes
· May manage clinical operations staff (Clinical Trial Assistant, CRAs)
Qualifications and Education Requirements
· 6+ years of Clinical Operations or related experience required with experience in hematology/oncology indications
· Bachelor’s degree required
· Bachelor’s degree or higher in nursing, or health science preferred
· Committed to the values of integrity, accountability, adaptability, and drive.
· Local San Francisco Bay Area candidates only
· Excellent teamwork and collaboration skills. Attention to detail required
· Proficient with Microsoft Office.
· Must have the ability to build and maintain positive relationships with management, peers, and direct reports
· Flexibility and willingness to solve problems that fall outside of immediate area of expertise
· Strong knowledge and experience of clinical operations, including interpretation and implementation of FDA regulations/ICH guidelines, is required
· Previous line management experience preferred
· Experience in global trials preferred
· Clear and concise verbal and written communication skills and strong organizational skills, with an exceptional attention to detail.
· Work independently in an interdisciplinary, fast-paced, often changing environment.
· Must be willing to travel