Senior Clinical Project Manager
Role and Responsibilities
- Manage the operational aspects of clinical trials and proactively identify and address 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
- Oversee contract organizations and external 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 and oversee internal and CRO 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
- Manage and report clinical operations project plan, including timeline, budget, resources and risks
- Lead or participate in the design of study materials such as CRFs, CRF completion Guidelines, Subject Diaries, Monitoring plan, Laboratory Manual, Pharmacy Manual
- Participate in protocol development, Informed Consent Form development, Clinical Study Report preparation, Data Review Committee activities as appropriate
- Manage the review and approvals of Informed Consent Forms and other study related materials
- Participate in the development, review and implementation of departmental SOPs and processes
- Develop and implement innovative process ideas to optimize clinical trial conduct and management
- Organize and manage internal team meetings, vendor meetings, investigator meetings and other trial-specific meetings
- Oversee implementation and maintenance of study-specific Electronic Trial Master File
- Assist with training vendors and team members on study protocol and processes
- Manage clinical operations support staff as assigned (Clinical Trial Associates, Clinical Research Associates)
Qualifications and Education Requirements
- 5+ 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, agility, 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 oncology 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