(Sr.) Clinical Trial Manager

AbelZeta Inc•Rockville, MD

9d•$129,624 - $166,000

About The Position

AbelZeta is a clinical stage biopharmaceutical company focused on the development of novel immunotherapy products. We are on a rapid growth trajectory and have a highly energized and accomplished team driving to new frontiers of care for cancer and autoimmune disease patients. We are seeking a (Sr.) Clinical Trial Manager to join our team. Reporting to the Head of Clinical Operations, the Clinical Trial Senior Manager will be a key member of the Clinical Operations Team. In this role you will help build the foundations for clinical operations as we take our programs into the clinic. You will independently be involved in clinical operations and logistics of multi-center, Phase 2 and Phase 3 clinical studies for oncology and play a key cross-functional role across AbelZeta. You will provide oversight and budget management of study vendors and study sites, as well as work cross functionally within AbelZeta with clinical, safety, biostatistics, translational research, and regulatory teams. CRO and vendor management is a key role of this position as well. This is a great opportunity to join a highly experienced team and make an impact on the large unmet need for therapy in autoimmune disease and oncology.

Requirements

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.

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.