Senior Clinical Project Manager

Tonix Pharmaceuticals* is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8 mg) is the first new treatment for fibromyalgia in adults in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® Symtouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg). Tonix is investigating TONMYA® in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. Tonix is also advancing a pipeline of immunology programs, including TNX-4800, a Phase 2 ready long-acting human anti-Borrelia OspA monoclonal antibody (mAb) for the prevention of Lyme disease in the U.S., and TNX-1500, a Phase 2 ready third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. In addition, the Company is progressing TNX-2900 (intranasal potentiated oxytocin), which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. To learn more, visit www.tonixpharma.com and follow the Company on LinkedIn and X.
*Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. TONMYA is a registered trademark of Tonix Pharma Limited. All other marks are property of their respective owners.
Position Overview
The Senior Clinical Project Manager is responsible for overseeing and managing trials within clinical programs. This includes management and oversight of CROs and other service providers. The Sr. CPM is responsible for planning, organizing, and directing the completion of trials on time, on budget, and within scope. This includes overall workload and clinical management of the trials in partnership with other functional areas.
Key Responsibilities
Assist with development of the protocol and informed consent form and/or program design
Master the basic elements of the study protocol, investigator brochure, informed consent forms, and study specific materials
Evaluate and qualify CRO’s/vendors/investigator sites in a systematic and organized fashion
Negotiate budgets and contracts; effectively communicate with third party vendors
Lead regularly scheduled project meetings or ad-hoc discussions with an agenda for tracking meeting minutes and action items
Manage and track vendor budgets, invoices/payments, and timelines; Report anticipated budget variance in a timely manner.
Coordinate with all relevant study team members to ensure studies progress on time and on budget
Effectively track and report on internal project metrics and study progress
Responsible for the registration and maintenance of the clinical trial design, status, and results as required by clinicaltrials.gov
Prepare, review, and approve study plans and manuals for study start up
Develop recruitment plans and materials; collaborate with recruitment vendors
Plan Investigator Meetings [such as attendee travel, accommodations, meeting schedule, presentations, etc.] and adhere to the set budget and timeline
Communicate study procedures, methods, and expectations to all parties
Assure delivery and/or return of required study supplies (IP, lab supplies, etc.) to/from sites
Oversee and approve site regulatory packages for initial drug shipments
Attend or lead monitoring and co-monitoring visits
Oversee data cleaning; track the issuing and resolution of data queries
Manage design and development of eCRFs, electronic data systems including database locks
Maintain inspection ready TMF, familiarity with TMF reference model
Contribute to clinical study report writing and review
Follow all established occupational health and safety procedures, good clinical practice (GCP) and standard operating procedures (SOPs)
Oversee work of junior staff by providing guidance and constructive feedback
Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
Qualifications
Bachelor’s degree in life sciences or related field; advanced degree highly desirable
Minimum 8 years in clinical operations or research with increasing levels of responsibility (e.g. clinical trial manager, clinical trial associate, clinical research coordinator, clinical research associate).
Minimum 4 years managing clinical projects, ideally from start to end of a trial.
Detail oriented and organized, and adept at data entry, reporting and maintaining comprehensive records;
High level of professionalism, including meeting-presence & etiquette;
Strong communication skills (both verbal and written), able to communicate with executives and staff;
Demonstrated ability to protect and maintain confidential and personally identifiable information;
Strong knowledge of ICH GCPs
Advanced level proficiency in Micros