Senior Clinical Project Manager
Tonix Pharmaceuticals · Berkeley Heights, NJ ·
- Seniority
- Senior
- Category
- Project management
- Experience
- 4+ years
- Visa sponsorship
- No
- Salary
- USD 115,000 – 166,500 / year
The Senior Clinical Project Manager at Tonix Pharmaceuticals oversees clinical trials from start-up through closeout — managing CROs and vendors, budgets, timelines, site activities, and data cleaning — to deliver studies on time, on budget, and within scope. The role requires deep knowledge of clinical operations systems (EDC, TMF, CTMS, IRT) and ICH GCP, based onsite in Berkeley Heights, NJ with
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 Microsoft Office products. Experience with Office 365 and SharePoint is a plus.
- Willingness to learn and navigate challenges, identify a resolution and be accountable for assigned tasks
- Strong experience with clinical trial systems (EDC, TMF, CTMS, IRT systems)
- Demonstrates a high level of problem-solving skills with little to no guidance
- Ability to mentor junior staff on tasks assigned for projects, and begin to develop people management skills
- Ability to travel up to 25%, more during peak periods (e.g. site selection and initiation)
- Ability to work independently with minimal supervision
*Please note that Tonix does not offer sponsorship for this role.
Recruitment & Staffing Agencies
Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes.
Compensation & Benefits
Tonix provides a comprehensive compensation and benefits package which includes:
- Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs
- Pet Insurance
- Retirement Savings 401k with company match and annual discretionary stock options
- Generous Paid Time Off, Sick Time, & Paid Holidays
- Career Development and Training
Tonix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, genetics, or any other characteristic protected by law. In addition to federal law requirements, Tonix complies with applicable state and local laws governing nondiscrimination in employment. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training. Tonix expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic, information, disability, veteran status, or any other characteristic protected by law.