DESCRIPTION:
Responsible for all aspects of clinical study planning and execution within pre-specified program plan, timelines and budget and includes, but is not limited to, preparation of study related materials, relationship management between study sites and vendors especially CRO, supervision of study related activities, , identification of project risks and contingency planning. Provides overall cross-functional leadership to achieve project objectives on time, within budget and with high customer satisfaction. Will handle CF, Phase 3 trials for 108,109, 110 and assist with regulatory.
SPECIFIC RESPONSIBILITIES INCLUDE:
• Manage integrations of all project team activities
• Responsible for the execution of a clinical development program from protocol design to the final clinical study report for one or several studies
• Responsible for coordinating all efforts for the trial both within Transave and through a wide variety of CRO and vendors
• Develop contingency/risk management plans for projects and assist Director of Operations in the preparation and execution of sound development strategies
• Track and manage project actual costs vs. budget (keep track of specific items/details in the budget and know whether expenses are on target)
• Interface with Finance acting as a liaison between Clinical and Finance
• Responsible for budget and forecast preparation for clinical studies
• Reviews and approves vendor invoices for payment and codes invoices
• Provides a variance analysis of budget to actual and notifies Finance of projected cost overruns/under-runs
• Manage contract research organizations
• Manage study sites
• Manage tracking systems for drug supply and use, enrollment of subjects, regulatory document flow, study timelines, financial information, Serious Adverse Events, performance metrics, data flow, etc.
• CRF and ICF review
• Travel will be about 10 – 20%
Licenses, certifications and degrees:
Bachelor’s Degree is required or equivalent experience. MS, advance degree in scientific discipline, business/finance courses is preferred. 4 – 7 years of experience gained with a CRO or Pharmaceutical Company working on Phase I - IV clinical studies. Must have Phase III experience
Role-related knowledge:
7-8 years clinical project management experience with clinical studies
Role-related (skills, abilities, behavior necessary to perform the role) including language, mathematical and reasoning (analytical) skills, intellectual, creative and/or communications abilities:
• Strong organization skill and ability to deal with competing priorities
• Strong reasoning and problem solving ability
• Excellent communication skills: written and verbal
• Leadership skills
• Knowledge of clinical trial management.
Knowledge of GCP regulations
• Good computer skills
• Good Presentation skills
• Apply project management best practices to programs
• Experience in clinical drug development
• Experience with pulmonary, infectious disease projects a plus
• Experience running early development (Phase I/Phase II) and Phase III clinical programs
• Solid knowledge of all aspects of clinical trials
• Experience managing CROs a MUST.
• Budgeting, timeline/resource management, and contract negotiation experience.
• Protocol and CRF review. You do not need to have written protocols.
• Extremely strong organization skill and ability to deal with competing priorities.
• Knowledge of clinical trial management.
• Knowledge of GCP/GMP/GLP regulations.
• Proficient with MS Office Suite (Excel, Word and PowerPoint) familiar with MS Project.
Organization Profile:
TRANSAVE is a biotechnology company whose mission is to improve the treatment of serious lung diseases through the company's next generation, proprietary liposomal delivery technology providing prolonged release of a drug in the lung while minimizing systemic exposure.