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Company : Lifelancer
Job Title: Associate Clinical Trial Manager
Job Location: California, USA
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
Mirador is a next-generation precision medicine company focused on immunology and inflammation. The company’s Mirador360 TM precision development engine leverages the latest advances in human genetics and cutting-edge data science to rapidly advance new precision medicines for patients living with chronic immune-mediated inflammatory and fibrotic diseases. Launched in 2024, Mirador has raised over $400 million from leading life sciences investors and is based in San Diego, CA.
Summary
Working with senior members of the clinical operations team, the Associate Clinical Trial Manager will provide trial oversight of Phase 1 or later phase studies and ensure clinical trials are conducted efficiently and aligned with corporate timelines.
Responsibilities
Oversees vendors (e.g., CRO, Biometrics, IRT, PK/Central Lab, eTMF, Safety, Clinical Supplies) for adherence to budget, timelines and organizational objectives and goals.
Develops strong vendor relationships and ensures continuity of relationships through all phases of the trial.
Participates and provides oversight of site selection, including gathering feedback from other functions.
Coordinates and manages various tasks in collaboration with other functions as needed.
Ensures subjects’ rights, safety and well-being are protected.
May conduct site oversight visits or co-monitoring visits.
Performs timely review of monitoring reports and associated deliverables demonstrating sponsor oversight.
Performs periodic reviews of the eTMF/TMF to ensure adherence with standards and compliance with the relevant regulations and guidelines.
Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
Evaluates and resolves site performance, quality or compliance problems and escalates per defined process as appropriate in collaboration with clinical operations management.
Contributes to team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement, and providing training as appropriate/required.
Tracks and coordinates trial related material availability, including clinical trial supplies and laboratory samples.
Works with vendors to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met.
Supports financial management of the study which includes review and approval of site and vendor invoices.
Identifies risk and mitigates as appropriate.
Supports audit/inspection activities as needed.
Maintains clinical trial registry entry/updates, as required.
Experience And Qualifications
Oversees vendor (e.g., CRO, Biometrics, IRT, PK/Central Lab, eTMF, Safety, Clinical Supplies) for adherence to budget, timelines and organizational objectives and goals.
Develops strong vendor relationships and ensures continuity of relationships through all phases of the trial.
Participates and provides oversight of site selection, including gathering feedback from other functions.
Coordinates and manages various tasks in collaboration with other functions as needed.
Ensures subjects’ rights, safety and well-being are protected.
May conduct site oversight visits or co-monitoring visits.
Performs timely review of monitoring reports and associated deliverables demonstrating sponsor oversight.
Performs periodic reviews of the eTMF/TMF to ensure adherence with standards and compliance with the relevant regulations and guidelines.
Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
Evaluates and resolves site performance, quality or compliance problems and escalates per defined process as appropriate in collaboration with clinical operations management.
Contributes to team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement, and providing training as appropriate/required.
Tracks and coordinates trial related material availability, including clinical trial supplies and laboratory samples.
Works with vendors to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met.
Supports financial management of the study which includes review and approval of site and vendor invoices.
Identifies risk and mitigates as appropriate.
Supports audit/inspection activities as needed.
Maintains clinical trial registry entry/updates, as required.
Skills And Abilities
Bachelor’s degree in a health-related field.
3 or more years of clinical trial management experience in the biotech or pharma industry, including CRO/vendor management, monitoring of budget scope, clinical site monitoring or related experience required.
Must have detailed knowledge of clinical drug development process including working knowledge of ICH, Good Clinical Practices (GCP).
Strong scientific communications skills.
Good presentation skills for diverse audiences (investigator meetings, site personnel, KOL interactions and internal project teams).
Ability to strike a balance between independent work and team interaction, be a team player in a cross-functional team.
Excellent project management skills.
Well-developed interpersonal skills, with experience in interacting with and influencing people, building strong positive relationships.
Proficiency in Microsoft Office and other productivity tools with an aptitude to learn new software and systems; ability to work with large databases.
Ability to travel if necessary.
The expected base pay range for this position is $100,000 – $125,000 plus bonus, equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. This range may be modified in the future.
All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, veteran status or other protected class.
All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, veteran status or other protected class.
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