Senior Clinical Project Manager

Position Overview

Advance clinical research through thoughtful planning, strong partnerships, and a commitment to quality and participant safety.

The Senior Clinical Project Manager oversees and drives the execution of trials within clinical programs, including management of contract research organizations (CROs) and other service providers. This role plans, organizes, and guides trial delivery to achieve milestones on time, within budget, and within scope, in partnership with cross-functional teams.

Guided by Tonix's core values of integrity, commitment, innovation, and passion, the Senior Clinical Project Manager brings teams together to navigate challenges, strengthen trial execution, and deliver high-quality clinical research. This role manages trial workloads and clinical operations, promotes accountability across partners, and identifies practical improvements throughout the trial lifecycle.

Key Responsibilities

• Contribute to the development of study protocols, informed consent forms, and clinical program design, bringing an operational perspective to study planning.

• Develop a thorough working knowledge of study protocols, investigator brochures, informed consent forms, and study-specific materials to guide effective trial execution.

• Systematically evaluate and qualify CROs, vendors, and investigator sites to support study requirements and quality expectations.

• Negotiate budgets and contracts and build productive relationships with third-party vendors through clear communication and shared expectations.

• Lead focused project meetings and ad hoc discussions, establish clear agendas, and document decisions, meeting minutes, action items, and follow-through.

• Manage vendor budgets, invoices, payments, and timelines; proactively identify and communicate anticipated budget variances.

• Align study team members around priorities, resolve operational obstacles, and drive progress against study timelines and budgets.

• Track, analyze, and communicate project metrics and study progress to highlight risks and support informed decisions.

• Manage clinical trial registration and maintain study design, status, and results information on ClinicalTrials.gov as required.

• Prepare, review, and approve study plans and manuals to support coordinated study startup.

• Develop recruitment plans and materials and partner with recruitment vendors to advance enrollment goals.

• Plan and coordinate Investigator Meetings, including attendee travel, accommodations, agendas, and presentations, within established budgets and timelines.

• Translate study procedures, methods, and expectations into clear guidance for study teams, sites, and service providers.

• Coordinate the timely delivery and return of required study supplies, including investigational product (IP) and laboratory supplies, to and from sites.

• Oversee and approve site regulatory packages for initial investigational product shipments.

• Attend or lead monitoring and co-monitoring visits to assess study conduct and support issue resolution.

• Oversee data cleaning and drive timely issuance, tracking, and resolution of data queries.

• Manage the design and development of electronic case report forms (eCRFs) and electronic data systems, and coordinate database lock activities.

• Maintain an inspection-ready Trial Master File (TMF), applying knowledge of the TMF Reference Model to support complete and accurate documentation.

• Contribute to clinical study report writing and review.

• Uphold established occupational health and safety procedures, Good Clinical Practice (GCP), and standard operating procedures (SOPs).

• Guide and mentor junior staff through clear direction, constructive feedback, and support for professional development.

• Put Tonix's core values into practice through integrity in study conduct and reporting, commitment to quality and follow-through, innovation in solving operational challenges, and passion for advancing clinical research.

Qualifications

• Bachelor's degree in life sciences or a related field; advanced degree highly desirable.

• Minimum of 8 years of experience in clinical operations or research with increasing levels of responsibility, such as clinical trial manager, clinical trial associate, clinical research coordinator, or clinical research associate.

• Minimum of 4 years managing clinical projects, ideally from trial startup through closeout.

• Strong attention to detail and organizational skills, with proficiency in accurate data entry, reporting, and comprehensive recordkeeping.

• High level of professionalism, including effective meeting participation, preparation, and professional etiquette.

• Strong verbal and written communication skills, with the ability to communicate clearly with executives, staff, and external partners.

• Demonstrated ability to protect confidential and personally identifiable information.

• Strong knowledge of International Council for Harmonisation (ICH) GCP guidelines.

• Advanced proficiency in Microsoft Office products; experience with Office 365 and SharePoint is a plus.

• Curiosity and willingness to learn, with the ability to navigate challenges, identify practical solutions, and take ownership of assigned responsibilities.

• Strong experience with clinical trial systems, including electronic data capture (EDC), TMF, clinical trial management systems (CTMS), and interactive response technology (IRT).

• Demonstrated ability to solve complex problems and exercise sound judgment with little to no guidance.

• Ability to mentor junior staff on project assignments and continue developing people management skills.

• Ability to travel up to 25%, with additional travel during peak periods such as site selection and initiation.

• Ability to work independently with minimal supervision while maintaining strong collaboration and accountability.