Clinical Project Manager (CTM)

Job Summary
The Clinical Project Manager is responsible for the routine cross-functional operations of assigned studies. The Clinical Project Manager ensures that assigned studies are delivered successfully, on-time, within budget, according to the expectations and with the highest level of quality possible.
Responsibilities
· Serve as the primary liaison with the project team for assigned studies.
· Responsible for the overall coordination and management of clinical trials from study inception through study culmination.
· Establish study milestones to align with company goals; ensure the project team is in alignment with study milestone dates; and track/report on study metrics and timelines
· Direct all project staff across functional areas to facilitate study progress.
· Develop and maintain project metrics, timelines, budget and deliverables including project plans, trackers and tools for assigned projects.
· Ensure that trials are conducted in adherence to study protocols, applicable SOPs, ICH/GCP guidelines and local government regulations.
· Negotiate site contracts and/or budgets and oversee accurate and timely distribution of investigator grants.
· Develop, implement and communicate project plans, monitoring plans, regulatory plans and all other applicable study materials.
· Development of local study tools and procedures as required
· Write, review and oversee the writing of study documents such as protocol, ICF, CSR, etc.
· Manage vendors (CRO, DM) to meet recruitment targets including:
o Ensure oversight of set-up, training, and monitoring of sites participating in clinical trials.
o Review site regulatory documents for accuracy and completion
o Timely review of trip reports
o Targeted and effective study team training
o Perform project management activities including taking meeting minutes/providing agendas to the clinical team, tracking screening/enrollment across all sites, and maintaining study status trackers.
· Communicate study-related issues, including:
o Communicate the progress of the study, potential risks and appropriate recommendations for identified risks to appropriate internal team members and to management on a regular basis.
o Escalate issues and critical project matters in a timely manner to appropriate team members and senior management.
Qualifications / Requirements / Experience
· Bachelors degree or more in related field
· 5+ years of experience in clinical trials
· Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
· At least 3 years of Clinical Project Management experience
· Work outside the normal office hours as required.
Specific Criteria:
· Experience in establishing relationship with investigators and study personnel
· Exceptional negotiating skills along with financial acumen
· Excellent written, oral communication and presentation skills – both in English and Hebrew
· Excellent interpersonal and organizational skills with demonstrated attention to detail.
· Demonstrated management and problem-solving capabilities, strong critical thinking, and analytical skills
· Good computer skills with good working knowledge of a range of computer applications included but not limited to MS Work and Excel
· Ability to meet deadlines, multitasks, and prioritize based on project needs
· Ability to work both as part of a team and independently
· Ability to lead team meetings and teleconferences