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

Preferred Skills

·        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