REMOTE Clinical Trial Manager
Small Biotech
Must support west coast hours
reports to the Sr. CTM
Job Description
Support the Study Lead and Study Execution Team (SET) to ensure trials are initiated efficiently and completed on time, within budget, and in compliance with Standard Operating Procedures (SOPs), FDA regulations, and ICH/GCP guidelines with minimal supervision. Collaborate with SET to develop, review, and facilitate Request for Proposals (RFPs), and contribute to bid defense meetings to select Contract Research Organizations (CROs) and other clinical vendors for the right strategic fit.
Responsibilities
Manage various clinical vendors to ensure that project and corporate goals are achieved on time and within budget, including review of monitoring reports, recruitment, and quality metrics in collaboration with CRO.
Actively manage and resolve site issues in collaboration with other functional lines and the CRO partner.
Contribute to the development and review of key clinical documents such as protocols, informed consent forms (ICFs), case report forms (CRFs), study reference manuals, and study plans.
Serve as a subject matter expert (SME) on various company/department initiatives and participate in the development, review, and implementation of departmental SOPs and processes.
Oversee and manage vendor contracts, forecast financials in partnership with finance, reconcile invoices against accruals, and ensure the accuracy of all CRO/vendor work order and change order updates.
Participate in the implementation and oversight of clinical systems including CTMS, TMF, EDC, and IRT.
Conduct clinical data review of data listings and summary tables, including query generation.
Engage in other study activities as needed, such as site selection, start-up, recruitment, protocol deviation, and TMF review.
Provide input and support in the development and review of key study documents, including protocols, ICFs, CRFs, study plans, Clinical Study Reports (CSR), and track key study metrics and progress reports.
Anticipate complex obstacles and clinical trial challenges, and implement creative solutions to achieve project goals and timelines.
Proactively identify potential study risks, recommend mitigation strategies/solutions, and facilitate discussions with internal and external stakeholders for implementation.
Establish and maintain strong relationships with internal cross-functional teams, CROs and vendors, and clinical research site personnel for successful execution of clinical trials.
Train investigators and site staff, vendors, and team members on study protocol and trial conduct processes.
Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, and conduct periodic TMF reviews/QCs as needed.
Ensure the clinical trial(s) are inspection-ready at all times and participate in Quality Assurance and/or regulatory authority inspection audits as needed.
Essential Skills
Clinical trial management experience, particularly in oncology and early phase trials.
Must be at CTM level with global study and vendor management experience.
Bachelor's degree in life sciences or related discipline with 6+ years of experience in clinical and drug development.
Advanced knowledge of domestic and global clinical study management and vendor management experience in oncology.
Understanding and implementation of FDA and ICH/GCP regulations and guidelines.
Self-motivated with a drive for continuous improvement and innovative thinking.
Results-oriented team player who enjoys collaboration and building positive relationships.
Detail-oriented and creative thinker with a passion for process optimization.
Excellent organizational, analytical, and communication (verbal and written) skills.
Ability to analyze and triage problems, prioritize accordingly, and propose solutions.
Additional Skills & Qualifications
Experience in early phase oncology trial management, including precision medicine trials.
Work Environment
This position offers a remote work environment, providing flexibility and a dynamic, fast-paced atmosphere in a rapidly growing company.
Job Type & Location
This is a Contract position based out of South San Francisco, CA.
Pay and Benefits
The pay range for this position is $80.00 - $107.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully remote position.
Application Deadline
This position is anticipated to close on Feb 28, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
