POSITION OVERVIEW:

Sutro Biopharma, Inc. is seeking a driven and talented individual to join our Clinical Operations team as we change the future of oncology. While collaborating with cross-functional departments, you will play a key role in maximizing our technology and progressing our novel therapeutics. We are dedicated to making a difference in the lives of patients, both as individuals and as part of a team.
The Clinical Trial Manager (CTM) Consultant is responsible for providing operational expertise and support for the Clinical Operations team with the day-to-day activities of executing for one or more clinical trials during the trial start-up, conduct, and close-out periods, in accordance with the appropriate clinical trial standards including ICH/GCP and applicable regulations. This position is located at Sutro’s headquarters in South San Francisco, California.

QUALIFICATIONS:

• Bachelor’s degree in health care or other scientifically related discipline is required.
• 7+ years of experience with 5+ or more years of experience in= clinical operations however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility
• Understanding of ICH/GCP and knowledge of regulatory requirements (eg. ICH/CFR guidelines)
• Experience of working as part of a large team, clear written and verbal communication skills and ability to partner with various stakeholders are critical for success in this role
• Proven ability to proactively identify and resolve/refer project-related operational issues; ability to work independently on routine assignments, or under supervision on new assignments.
• Ability to handle a moderate volume of highly complex tasks within a given timeline.
• Requires strong organizational skills, attention to detail and ability to prioritize and problem solve.
• Willingness to travel as necessary, consistent with project needs
• Computer proficiency (Outlook, MS Word, Excel, and PowerPoint)
• Some travel (domestic and international), up to 15%

• Supports the development of operational strategies including country and site feasibility and selection, CRO and vendor identification and selection
• Contributes to the development and management of the trial timelines, budget, tracks study specific payments and flags any variances
• Supports development and maintenance of vendor contracts and budgets in collaboration with the Clinical Trial Leader, legal and finance
• Provides day-to-day management of study vendors to ensure delivery against contracted scope of work, escalating risks/issues to the study team
• Reviews site visit reports, under the direction of the Clinical Trial Leadership
• Initiates, reviews, and reconciles study files in the Trial Master File internal and with CROs
• Maintains accurate tracking and reporting of study metrics to support the conduct of the clinical trial(s) from start-up to close-out.
• Collaborates closely with supply chain to forecast, manage and track drug supplies
• Coordinates investigational product release activities across clinical sites
• Ensures sites have all the appropriate non-clinical supplies (e.g. lab kits) through close collaboration with the relevant vendors and management of the supplies
• Provides operational input in the development and review study documents (e.g., protocol, informed consent form, eCRF, site instructions, diaries, lab manual, Pharmacy Binder, Study Management Plan, etc.) and clinical site documents (e.g., site specific informed consent forms)
• Partners with Data Management and Clinical Science to oversee data entry completion and escalating any data quality issues to the CRO
• Build and maintain effective working relationships with all relevant stakeholders across and up and down the organization and with CROs, external vendors and partners
• Leads the study execution team and attends departmental and study specific meetings
• Contributes to the development and review of Standard Operating Procedures
• Assists with study-specific training of CRO staff
• Assists in the preparation of Investigator and Study Coordinator Meetings