Clinical Project Manager

Role Summary

The Clinical Project Manager is a member of the Zenas Clinical Operations team and is responsible for supporting the day-to-day operational management of one or more global clinical trials. The CPM, under the direction of the Clinical Project Lead, participates in a cross-functional team to ensure alignment of activities with study projects and timeline. This position reports to the Senior Clinical Project Manager.

Responsibilities

• Supports the management of operational aspects of one or more global clinical trials from start-up to close-out
• Participates in planning and communication with cross functional teams within clinical development to ensure proper execution of clinical trials
• Attends internal study team meetings and CRO/vendor meetings and follows up on outstanding issues assigned to him/her
• May take on direct management of selected vendors under supervision of the CPL
• Reviews assigned vendor invoices, and change orders and provides feedback to the CPL
• Collaborates with Clinical Site Management on activities to meet study enrollment goals and timelines, including patient recruitment planning
• Contributes to the development of clinical documentation including but not limited to study protocols, informed consents, Study Reference Binder, study level plans and manuals and training materials
• Partners with Operational Excellence on eTMF compliance activities
• Participates in the development and design of CRFs and CRF Completion Guidelines, including participating in the EDC and IRT specification process and UAT
• May participate in departmental initiatives

Qualifications

• B.A. or B.S. degree, preferably in a scientific discipline
• A minimum of 5 years of industry experience in the pharmaceutical industry or equivalent, plus 1+ years of trial management experience
• Solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process
• Independently motivated, detail oriented and good problem-solving ability. Ability to make independent, timely, and risk-based decisions
• Excellent written and verbal communication skills
• Experience interacting with key functional stakeholders (clinical development, regulatory, QA, supply chain)
• Comfortable working in a demanding, fast-paced, start-up culture with evolving processes. Flexible and able to adapt to new situations as the business demands
• Demonstrates flexibility to work non-traditional work hours when needed, given international operations across time zones
• Ability to do some international travel [up to 25%]