PM

PM

Purpose of Job:

project managers are charged with oversight of all relevant functional areas involved in delivering NovaTrials services. Assigned projects may be global or national, and project managers may oversee multiple studies.

The PM will work closely with NovaTrials CEO and other cross-functional representatives, including Clinical Data Management, Biostatistics, Regulatory/QA etc. to ensure successful completion of all clinical activities/project deliverables within the required time frame and budget.

Job components:

Develop and maintain good working relationships with company clients as well as investigators and study staff
Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study specific manuals and procedures
Negotiate and manage the budget and payments for investigative sites, if applicable
Write or contribute to preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents
Oversee performance of third party vendors and field CRAs including co-monitoring
Collaboration with major functional areas to identify and evaluate fundamental issues on the project, interpret data, make good business decisions and ensure the implementation of timely solutions
Accountability for ensuring all project deliverables meet customers' expectations as well as NovaTrials standards
Understanding scope of work, financial aspects of the project, expected project performance and strategies involved e.g. patient recruitment
Attendance at Clinical Project Team set up meetings with the sponsor
Attendance at Clinical Project Team routine meetings with the sponsor
Being aware of communication channels per each assigned project for quick escalation of issues
Planning the assignment of projects to CRAs based on clear understanding of their FTE status and pipeline projects