BranchFactor Summary

The original posting with the fluff stripped out

Expected experience: 8+ yrs
Management level: People management
Visa sponsorship: Not offered

Compensation

No salary listed for this role.

Role speciality

Clinical OperationsClinical Trial Management

Useful technologies

Microsoft OfficeOffice 365SharePoint

Required qualifications

Field of studyLife Sciences (or related)

Study levelBachelor's

Preferred qualifications

Study levelMaster's or higher

Original posting

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.

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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

Clinical Project Manager at Tonix Pharmaceuticals — BranchFactor