Location: Remote (US) - requires up to 10% travel including overnight stays
Contract Length: 6 Months (extensions possible)
Pay Rate: $42-52/hr
Clinical Study Project Manager
The Clinical Study Project Manager is responsible for executing clinical trial endpoint tool development and validation studies in Aesthetic Medicine, as led by the Clinical Development team.
- Ensure endpoint-related studies and development work are executed with quality and efficiency, on-time, within budget, and while meeting strategic company objectives.
- Responsible for executing endpoint-related studies in compliance with quality standards (ICH/GCP, global regulations, and company policies and procedures).
- Help develop program strategy and targets in relation to endpoint tool creation, in collaboration with project leaders.
- Leads study team meetings and collaborate with cross-functional team members.
- Responsible for regular updates to the cross-functional team and stakeholders on study status, and ensures relevant systems are kept up to date.
- Responsible for study budget creation and oversight of spend against approved budget.
- Collaborates with other team members and departments to lead vendor selection, scope development, management, and the oversight of external vendors in compliance with company processes, procedures, and applicable regulations.
- Responsible for generating study related training for the study team, clinical trial study sites, and vendors for assigned studies.
- Proactively identify, address and/or escalate study related risks, issues, and opportunities for improvement/efficiency.
- Minimum of a bachelor's degree, typically in nursing or scientific field
- Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials.
- Competent in the application of standard business procedures (i.e., company standard operating procedures, ICH/GCP guidelines, global regulations, ethics and compliance).
- Demonstrates a high level of core and technical competency through management of various components of clinical trials and/or endpoints tools development.
- Possess good communication skills and demonstrated leadership abilities.
- Advanced degree in scientific or management field.
- At least 5 years of Biopharma related clinical research project management experience, specifically in Aesthetic Medicine.
- Previous exposure to endpoint tool development in Aesthetics.
- Experience in protocol study design.
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.