LOCATION : Berkeley, CA – USA REPORTS INTO : Director, Clinical Operations SUMMARY & SCOPE : The Senior Clinical Trial Manger (CTM) is responsible for clinical trial management activities and provides daily management of multiple study activities and study personnel.
CTM is responsible for setting up and managing functional aspects of studies including Clinical Research Organization (CRO) selection/oversight, investigational product management, Central Lab management, and financial management of clinical studie(s).
CTM may also be responsible for monitoring clinical sites or oversight of monitoring to verify that the rights and well-being of human subjects are protected; that the reported trial data are accurate, complete, and verifiable from source documents; that the conduct of the clinical trial is in adherence to protocol, GCP/ICH, and SOPs.
PRIMARY RESPONSIBILITIES : May act as an independent study lead or may work within a team under the direction of a Sr.
CPM or AD/D including lead and facilitate Study Execution Team Meetings Plans, executes, and/or assists in study start-up activities (globally or regionally), including: Lead study feasibility study(s) to identify clinical sites and plan for study execution (e.g., enrollment projections) In collaboration with CPM/AD develop overall study execution plan CRO and vendor identification and selection May be involved in the CRO and vendor task order development and budget negotiation Author and/or review/edit key study plans and materials including: Monitoring Plan, Laboratory Manual, Pharmacy Manual, Communication Plan, and CRF Completion Guidelines Site Initiation and Investigators’ Meeting Presentations Essential document templates: Informed Consent forms (master and regional adaptions) Other protocol-specific tools, as required Partner with and oversee CRO team hired to support trial Regularly attend team calls Provide continuous direction and training Perform on-site co-monitoring (oversight) visits, as needed Clearly communicate and effectively collaborate with external vendors and development partners (both in writing and verbally) Oversee and/or manage clinical study files/documents within electronic and/or paper Trial Master File As required, participates in the development, review and implementation of departmental SOPs and processes Identifies and/or implements process improvement ideas Oversees and/or manages the investigator grant process for clinical sites Creation of negotiating parameters with CRO Ensuring timely site payments Assists with protocol, IB, and CRF development and finalization Oversee CRO and/or contractors in completion of monitoring tasks and/or independently performs pre-site selection and site initiation visits; may conduct other on-site visits as required (eg, IMVs, COVs, co-monitoring visits) Reviews study monitoring reports, as required, and follow-up of specific issues within project specific timelines Develops and maintains excellent cross-functional relationships; leads ad hoc internal meetings as necessary SUPERVISORY RESPONSIBILITIES : May be direct line manager of CTAs and Associate CTMs Oversees and manages work of Clinical Operations contractors and CRO/vendor team members EDUCATION & EXPERIENCE : Bachelor’s level degree (in life sciences, pharmacy or nursing preferred) Prior related clinical trial management experience including experience managing direct reports Oncology experience preferred; multi-national trial experience preferred Experience managing outside vendors, e.g., CROs and labs Experience as an on-site monitoring CRA and/or study coordinator Familiar with advanced concepts of clinical research and able to work effectively in a dynamic team/matrix environment Knowledge of clinical research operations, including interpretation and implementation of FDA regulations and ICH GCP (E6) is required Desired soft-skills: Flexible, detail-oriented, innovative, diplomatic, and efficient Knowledge of the principles and practices of basic computer applications used in general office setting, including word processing, spreadsheet, database management, presentation software, and internet search engines Advanced capabilities with Microsoft PowerPoint, Word, Excel, and Project desired Basic math and standard business level English grammar and usage Travel may be required between 20-50% during peak times; both domestic and/or international