Clinical Trial Manager/Senior Clinical Trial Manager
2 months ago
Boundless Bio (BBI), Inc. (Nasdaq:BOLD) is a San Diego-based, clinical-stage oncology company dedicated to delivering transformative therapies to patients with previously intractable oncogene amplified cancers. We are seeking a motivated and experienced Clinical Trial Manager/Senior Clinical Trial Manager who will be an essential contributor to our BBI-825 program and will support our strong pipeline overall within the clinical operations group. The successful candidate is an independent self-starter with strong attention to detail.
Responsibilities:
- In partnership with CROs, provide guidance and daily oversight for the successful management of all aspects of global oncology trials
- Monitor the progress of trials including enrollment, clinical trial material inventory, and study reporting for leadership
- Contribute to the writing and review of protocols, consent forms, IRB/EC materials, manuals, plans and other study documents
- Participate in the process of site and vendor selection and qualification
- Oversee Boundless-managed vendors, including financial tracking and approvals, timeline management, strategic problem solving, and documentation and filing of oversight activities
- Contribute to the development, set-up, and user acceptance testing for all validated electronic systems (e.g., EDC, IRT, eCOA)
- Oversee operational management of study PK/PD samples and drug supply at study sites
- Oversee monthly subject and vendor accruals for 825 study and support the Associate Director, Clinical Operations, in accrual management as required
- Coordinate with legal and follow-up on all outstanding matters for 825 (new contracts, CTAs, CDAs)
- Coordinate with cross-functional team members (e.g. regulatory, translational, precision medicine, CMC, pharmacology) to ensure seamless study execution, including vendor alignment with current business strategies
- Provide tracking and administrative support for Clinical Supply Partnerships
- Provide study updates at clinical operations meetings-including updating other clinical staff and upper management on patient recruitment, trial issues, investigator's feedback, monitoring issues, patient enrollment issues and presenting a plan of action for resolution of issues
- Perform all duties in keeping with the Company's core values, policies and all applicable regulations
Skills and Experience:
- Bachelor's degree in a scientific or health related field or equivalent combination of education and experience
- 5+ years of experience directly supporting clinical research trials or relevant equivalent experience
- Analytical problem-solving experience, including the ability to anticipate and resolve obstacles with strong reasoning skills
- Excellent organizational skills and attention to detail
- Working knowledge of clinical drug development process as well as ICH, GCP guidelines, and US FDA regulations
- Effective communication and interpersonal skills; ability to build relationships internally and externally
- Cross functional and cross-cultural awareness, someone who seeks out diverse perspectives and considers these perspectives in making decisions
- Patient-centric philosophy towards research
- Ability to thrive in an entrepreneurial, fast-paced and dynamic work environment
- Familiarity with medical terms
- Demonstrated writing skills to deliver clear and effective messages
- Demonstrated expertise with PCs and standard Microsoft Office software applications
- Up to 20% travel
The anticipated salary range for this role is $135,200 to $185,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. In addition to base salary, BBI employees are eligible for an annual bonus incentive, and an equity stock option grant. BBI offers a competitive benefits package including, medical, dental, vision, and life insurance for employees and their dependents. We also offer and an Employee Stock Purchase Plan (ESPP) and a 401(k) plan with a matching contribution in addition to a flexible time off policy.
Boundless Bio fosters an inclusive company culture that values diverse talent, backgrounds, and experiences. We are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation, veteran status, or any other protected categories.
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