The Clinical Study Manager (CSM) is responsible for the overall management of national/international assigned clinical studies to ensure study compliance, quality, execution, and on-time reporting. The CSM will represent the clinical department on various internal project teams, and manage direct and/or non-direct personnel assigned to responsible studies.
- Project lead who oversees, plans, develops, and executes multi-national clinical trial(s);
- Drive protocol (and associated documentation) completion of assigned clinical studies;
- Collaborate with cross-functional teams to develop and execute plans to ensure timely completion of study deliverables.
- Review and report on key study milestones (eg, eligibility, primary endpoint data, etc.) and determine appropriate action with the study team
- Ensure that studies are conducted in accordance with the study protocol, SOPs, ICH / GCP regulations, and specific study procedures.
- Interacts with study sites and vendors;
- Validate that the performance of CROs and external providers is adequate, to ensure compliance with the study protocol and in accordance with the scope of work;
- Manage contract requirements (sites and vendors);
- Provide project support and performance management to project team members;
- Lead assigned clinical study team (indirect and direct reports, if applicable);
- Serve as the primary contact for all protocol clarifications and logistical project-related issues;
- Write interim and final clinical study reports used for regulatory submissions;
- Assist with establishing and/or modifying department procedures and systems.
- Bachelor’s degree in health sciences or related field required with 6+ years of Clinical Research experience
- Knowledge of US and OUS clinical trial regulations and GCPs
- Experience working on global study team(s)
- Proven organization skills and the ability to manage multiple priorities
- Excellent oral and written communication skills
- Knowledge of medical terminology
- Ability to work independently
- Ability to work hours required for study conduct
- Strong planning and scheduling skills
- Excellent computer skills including proficiency in Microsoft office
- Critical thinking and sound communication skills
- Ability to travel up to 20%
- Experience in the field of pulmonology
- 3+ years of study manager experience
- Experience managing direct reports
- US and OUS trial experience
- EDC experience
Physical Job Requirements:
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Upon request, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.
Nuvaira is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.