Note: The job is a remote job and is open to candidates in USA. AbelZeta is a clinical-stage biopharmaceutical company focused on developing novel immunotherapy products for cancer and autoimmune disease. The Senior Clinical Trial Manager will lead clinical operations and logistics for multicenter Phase 2 and Phase 3 oncology studies, managing vendors, sites, budgets, timelines, and cross-functional collaboration.
Responsibilities
- Innovate, develop, and implement clinical trial strategies and protocols in accordance with regulatory requirements and company goals
- Lead and manage cross-functional teams to ensure successful execution of clinical trials
- Oversee site selection, patient recruitment, and monitoring of study sites to ensure adherence to study protocols and timelines
- Ensure data quality and integrity through close monitoring of study data and regular communication with key stakeholders
- Develop and manage trial budgets and timelines, ensuring that studies are completed on time and within budget
- Manage vendor relationships and ensure that clinical research organizations (CROs) and other external service providers meet or exceed performance expectations
- Support and lead contract negotiations with vendors and clinical sites for clinical trial services
- Ensure investigational sites’ compliance with regulatory requirements including Sponsor’s SOPs and FDA and ICH guidelines
- Communicate regularly with key stakeholders, including investigators, study coordinators, and senior management, to ensure timely and effective communication of study progress and issues
- Act as the escalation point of contact for investigational site support
- Participate in the development of departmental standard operating procedures and best practices
- Job requires approximately 25% travel over the year, which will mainly be domestically within the US
- Other duties as assigned
Skills
- Masters degree and 6+ years of relevant academic or pharmaceutical clinical research experience OR Bachelor's degree and 8+ years of relevant academic or pharmaceutical clinical research experience
- Experience in developing and implementing standard operating procedures and best practices for clinical trials
- Strong knowledge of clinical trial design and execution, as well as regulatory requirements for clinical trials
- Strong working knowledge of and interest in complex cell immunology
- Previous experiences in management of immuno-oncology and Cell and gene therapy clinical trials
- Ability to manage and motivate multidisciplinary CRO teams critical to subject treatment, safety and trial oversight
- Excellent oral and written communication skills to communicate effectively with internal and external stakeholders (including KOLs, CROs and sponsor stakeholders)
- Excellent project management skills, including the ability to prioritize tasks, delegate responsibilities, and lead cross-functional teams
- Expertise in GCP, ICH guidelines and FDA regulations
- Demonstrated ability to work independently and in a team environment
- Extensive experience in a variety of laboratory databases, electronic data collection (EDC), electronic capture report forms (eCRF) electronic medical records (EMR) and eTMF platforms
- Budgets, contracts and accounts payable experience
- Job requires approximately 25% travel over the year, which will mainly be domestically within the US
Benefits
- Defined career path and annual performance review and feedback process.
- Comprehensive Benefits Plan, including medical, dental, vision, life Insurance, short-term and long-term disability insurance, and more!
- Competitive company 401k match.
- Paid holidays, sick leave, and annual leave.
Company Overview