Associate Clinical Trial Manager
San Francisco Bay Area
Salary: $120,000-$145,000
A well-funded Bay Area radio-pharma biotech company is looking to add on to their clinical operations team. This company is reimagining the future of cancer treatment through innovative radiotherapeutics, and you can contribute to transform the treatment of cancer entirely. They're developing a novel precision medicine approach aimed at transforming patient outcomes in oncology though a best-in-class radiotherapy that selectively destroys tumor cells while sparing healthy cells.
The leadership team at this company is poised to make it a standout in radiotherapies. Their CEO has 20+ years in life sciences and most recently secured $500M in Series A funding for a precision neurology biotech. The CMO brings experience from some of the most successful pharmaceutical companies in the world.
They've had their first IND submission this year, with 5 additional cancer targets in their pipeline. They have already raised $140 Million in funding, and are operating in the highly innovative radio-therapy space.
Key Responsibilities
* Support the management of clinical trial activities to ensure studies are completed on time, within budget, and in compliance with regulatory standards, standard operating procedures (SOPs), and ICH/GCP guidelines.
* Help oversee essential trial aspects, including study start-up, patient enrollment, site interactions, and data management, proactively identifying and resolving issues.
* Draft and review key study documents, including informed consent forms, case report forms, study manuals, and other trial materials.
* Assist in selecting and managing study sites and evaluating CROs and other service providers, as well as overseeing contracts and budgets.
* Work towards project goals, managing timelines and deliverables to align with organizational objectives.
* Provide study updates to cross-functional teams and help address issues with sites and CROs through analysis and action planning.
* Contribute to the development of study tools and resources to enhance data quality and trial efficiency.
* Participate in training new team members on study processes as needed.
* Track study progress, maintain relevant metrics, and keep the team informed.
* Serve as a key point of contact for study sites, and participate in assessing and resolving any safety or patient care issues.
* Oversee and support contract and budget negotiations with clinical sites.
* Assist in planning and presenting at investigator and CRO training meetings.
* Conduct site visits as needed, including qualification, initiation, monitoring, and close-out visits; perform oversight visits to review and assess CRO activities.
* Support internal and external audits, helping to address and resolve any findings.
Qualifications and Experience
* Bachelor's degree in a scientific or health-related field.
* At least 2 years of experience in clinical research, ideally within a biopharmaceutical or CRO setting.
* Oncology trial experience is highly preferred; early-phase development experience is beneficial.
* Knowledge of FDA regulations and ICH/GCP guidelines is essential.
* Strong organizational and multitasking skills, with the ability to work in a collaborative team environment.
* Excellent written and verbal communication skills.
* Problem-solving and negotiation abilities, with the ability to adapt as needed.
* Proficiency in Microsoft Office and experience with clinical trial management systems (e.g., Medidata Rave, InForm).
