Senior Clinical Project Manager

Tonix Pharmaceuticals•Berkeley Heights, NJ

3d•$115,000 - $166,500

About The Position

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.

Requirements

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

Nice To Haves

Experience with Office 365 and SharePoint is a plus.

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