Job Specifications
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.
Responsibilities
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
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%
Sound exciting? Apply today and join our team!Sutro Biopharma, Inc. encourages all colleagues to be fully vaccinated for COVID-19 prior to the first date of employment. As an equal opportunity employer, we believe in fostering a culture that is inclusive and values diversity in background and opinions. Sutro Biopharma hires extraordinary individuals into every position in the company and is committed to the diversity of our team. Our company progresses without regard of race, ethnicity, gender, sexual orientation, religious belief, age, disability or citizenship status. We are dedicated to creating a safe environment where our employees can grow and succeed together. To recruiting firms: Sutro Biopharma does not accept agency resumes and solicitations from third-party agencies. Please do not forward resumes to our hiring managers or employees. Sutro Biopharma is not responsible f