Clinical Research Business Development Manager III (20212 in South San Francisco, CA

Due to high volume, individual LinkedIN profiles cannot be reviewed. Please read entire job description below and if qualified, please send current WORD copy of your resume. US based candidates ONLY, please NO sponsorship, NO relocation The Clinical Program Manager (CPM) is responsible for clinical trial planning and execution of a given clinical trial program The CPM is responsible for ensuring that clinical trial (s) in a given program are conducted per ICH/GCP and regulatory compliance. The CPM works under the supervision of a Director and serves as primary clinical operations contact for trial management of a particular clinical program, depending on size and complexity of the program. Has overall responsibility for clinical trial timelines and budgets. Provides guidance and oversight for the successful management of all aspects of global clinical trials within designated program budgets and timelines. Anticipates moderately complex obstacles and client difficulties and implements solutions to achieve project goals. Responsible for development and monitoring of clinical program budgets and timelines. Manages the cross-functional Study Execution Team (SET) to ensure that timelines, cost and quality metrics are met and that study execution adheres to the protocol. Responsible for key study deliverables. Communicates project status and issues from SET to Clinical Team. Responsible for creating and managing clinical program timelines, including linking of multiple trials, in conjunction with CPD. Responsible for managing clinical trial timelines from concept approval through CSR for a particular study and reporting to Sr. mgmt. Responsible for cross-function management and logistical deliverables of a given clinical trial program, including integration of activities from Clinical Development, Regulatory, GPRM, DM, Biometrics, Clinical Supplies, QA to lead to successful study conduct. Leads oversight of trial risk mitigation activities through SET and escalates to cross functional leads, Senior management or Issue Escalation Team as appropriate. In Conjunction with Director, responsible for oversight of clinical trials Leads global vendor management for a given program. Accountable for vendor oversight plans for clinical trials. Leads Supplier selection process in conjunction with procurement. Develops Request for Proposals (RFPs) with procurement department, select CROs/vendors, and manages external resources. Accountable for ongoing vendor oversight (e.g. CROs, IVRS, Imaging) including escalation and management of initial SOW, budgets, vendor performance management, issue resolution and issue escalation. Responsible for financial management of vendors, ensuring that vendors are working to scope and are within scope of their budgets. Responsible for developing protocol timelines and management of the protocol through the protocol development process, including bringing protocol to PRC. Write sections of protocol and amendments, and ICF's. Develops and maintains guidance and process instruction documents, maintain study documents (consent templates, site procedural instructions etc). Responsible for managing protocol amendments, including content, budgets and timelines associated with amendment. Recruit, hire, mentor, and manage Clinical Trial Managers (CTMs) direct reports and support their professional development. Clinical program lead for internal and external study team meetings, dependent upon size and complexity of trial. Assigns responsibilities to the CTM/CTS/SCTS to ensure study execution and proper vendor oversight is being maintained for the lifecycle of the trial. Manages department teams or task forces to improve processes for trial execution. May be responsible for SOP review and development. May determine activities critical to company success and priorities within functional area. With limited supervision may participate in or lead departmental strategic initiatives. Participates in development of Standard Operating Procedures (SOPs), Clinical Study Reports, INDs, NDAs, and other clinical, regulatory, safety documents. Perform other work related duties as assigned. OTHER DUTIES