Sr. Clinical Project Manager

Role Summary

The Sr. Clinical Project Manager is a member of the Zenas Clinical Operations team and is responsible for the day-to-day operational management of one or more global clinical trials and oversight of CROs and clinical vendors. The CPM participates in a cross-functional team and partners with internal and external team members/key stakeholders ensuring alignment of activities with study projects and timeline. This position reports to the Senior Director, Clinical Project Management.

Responsibilities

• Manages all operational aspects of one or more global clinical trials from start-up to close-out; proactively identifies and resolves operational issues to assure adherence to timelines, budget and milestones while ensuring compliance to applicable SOPs, guidelines, and regulations.
• Participates in planning and communication with cross functional teams within clinical development to ensure proper execution of clinical trials.
• Participates in evaluation and selection of clinical study vendors including CRO, Data Management, IRT, Central labs, Imaging, etc.
• Manages and provides day-to-day oversight of CROs and third-party vendors including set-up, logistics, documentation, and clinical supplies needed for clinical trial(s)
• Responsible for the trial level clinical operations budget, invoices, and change orders.
• Participates in patient recruitment planning collaborates with Clinical Site Management on activities to meet study enrollment goals and timelines.
• Develops and maintains study timelines, enrollment dashboards and status reports for senior management and reports on issues as required.
• 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.
• Participates in the development and design of CRFs and CRF Completion Guidelines, including participating in the EDC and IXRS specification process and UAT.
• Contributes to and may lead the development of presentations for clinical sites, team and investigator meetings.
• May assist with the development of any new or updated SOPs/processes for the clinical department.
• Trains, mentors and may manage junior team members.
• May participate in departmental initiatives

Qualifications

• B.A. or B.S. degree, preferably in a scientific discipline
• A minimum of 7 years of industry experience in the pharmaceutical industry or equivalent, plus 4+ years of trial management experience managing study teams for phase I, II or III studies. Multi-country global study experience is required.
• Prior experience in management of CROs
• Experience with clinical study budgets
• 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 travel domestically and internationally (minimum of 25%) including travel to the office a minimum of 6 times a year if not based locally.

Education

• B.A. or B.S. degree, preferably in a scientific discipline