The incumbent is responsible for conducting tasks related to the trial, as assigned; escalates issues and recommends solutions to address concerns; with the guidance from the Director/Associate Director Clinical Operations/Senior Clinical Trial Manager.
KEY ROLE AND RESPONSIBILITIES:- Conducts tasks related to the trial as assigned; escalates issues and recommends solutions to address concerns
- Develops tactical plans, detailed process steps and creates forms as needed for efficient trial execution; collaborates and seeks feedback from broader study team stakeholders to improve/optimize recommendations
- Responsible for oversight of defined tasks with CRO partners; ensures deliverables are conducted on a timely, quality basis. Raises issues quickly to CTM/Sr CTM for resolution; makes recommendations on how to address concerns
- Tracks inputs and deliverables day-to-day in partnership with the Clinical Operations team; identifies ways to improve the way we track study progress, reaches out to cross-functional partners for follow up and pull through.
- Collaborates effectively; operates as a mentor and subject matter expert for more junior clinical team members
- Supports TMF maintenance activities through timely filing of study and vendor documents, assisting with TMF review, reporting findings to CTM
- Continues to learn and apply ICH GCP guidelines; stays current with evolving expectations and applies new protocols as required; recommends processes and procedures that support effective trial management
- Tracks study expenses, as directed by Associate Director or Sr CTM, tracks vendor invoices, routes invoices for approval.
PREFERRED EDUCATION: - BS in Life Sciences, or related discipline
PREFERRED EXPERIENCE: KNOWLEDGE, SKILLS AND ABILITIES:- Experience in Oncology clinical trial programs required
- Proven support of clinical studies for 2+ years; early phase and start-ups a plus
- Field/site monitoring experience a plus; sponsor in-house experience a plus, Oncology drug development experience a plus
- Track record of collaborating and managing CROs and other external vendors to deliver successful trial outcomes
- Operates effectively in cross-functional, multi-disciplinary teams
- Understands FDA regulations and ICH GCP guidelines; learns how to successfully apply these to studies to drive effective, efficient and timely strategies
The salary range for this position is $100,000 to $130,000, annually, with the opportunity to earn an annual bonus. The salary range is an estimate, and the actual salary may vary based on Lyell's compensation practices and an applicant's qualifications and experience. Employees are also eligible to participate in Lyell's Equity Incentive Plan.
We've learned from experience that some of the best people don't always match our requirements perfectly - if you're interested and think you could fit, please don't hesitate to apply.
