|Title:||Manager, Clinical Operations- GCD|
|Location:||Remote - United States|
|Department:||Global Clinical Development|
|Job Status:||Full-time, Benefited|
The Manager, Clinical Operations- GCD will lead the NA monitoring organization, oversee the creation of monitoring plans and tools, develop training and ensure compliance to regulatory and corporate requirements. The leader will also champion and ensure compliance with, ICH Good Clinical Practices, Standard Operating Procedures, project, regulatory and local requirements. The role will also oversee financial reporting and analysis for the monitoring organization to meet the financial targets set forth by management. The Manager will develop operational and staffing plans that allow for delivery, quality and financial metrics are met.
This is a full time benefited role working from home.
- Lead and mentor the clinical team
- Oversee monitoring activities and ensure they are conducted in accordance with GCP and Celerion SOPs.
- Initial and ongoing approval of monitor training and oversight.
- Provide initial and ongoing training to monitoring team and site personnel as needed
- Ensure documentation of all monitoring activities in a timely manner in accordance with project and SOP requirements.
- Development of monitoring plans, tools and trainings
- Review and support the creation of Site Initiation Visit materials including presentation slides and other training aides.
- Develop and review study budget and contract, as well as subcontractor budgets and contracts.
- Responsible for sourcing subcontractors as needed for specific duties, such as blinded and unblinded independent monitoring contracts.
- Oversight of monitoring activities including the scheduling of visits.
- Work with Celerion Finance department to determine current and forecasted revenue.
- Ensure department and study finances are meeting revenue targets
- Support business development activities including budgets, proposals and bid defenses
- Support GPMs and CPMs in the development of fees and bids
- Track and monitor all financial aspects of Celerion Monitoring Services for internal reporting purposes,
- Oversee the planning of visits to ensure adequate staffing
- Review invoices and approve payments.
- Providing coding to accounting to process approved payments.
- Reconcile internal or external monitoring bids to verify hours worked are hours invoiced.
- Participate and assist lead CRAs in review of monitoring reports and assess for trends
- Review audit reports and assist in resolution of cited issues, analyze findings for systemic issues, trends or areas for improvement
- Engage in process improvement activities and building of infrastructure
- Perform other tasks as assigned by leadership
- Bachelor's degree, preferably in science, nursing, other biomedical discipline, or equivalent.
- Minimum 10 years clinical research experience as a CRA or equivalent such as research coordinator or relevant internal clinical experience.
- Excellent oral and written communication skills.
- Excellent relationship building skills.
- Highly organized.
- Working knowledge of ICH GCP and clinical research regulations.
- Proficient computer skills, i.e., MS Word, Excel, PowerPoint.
- Excellent problem-solving and decision making skills.
- Familiarity/experience with Celerion preferred.
- Masters or other advanced degree preferred.
*Equivalent education and experience will be considered.
Celerion’s focus is on the implementation of innovative strategies to generate key data very early to enable go/no-go decisions in drug development. With a large clinical capacity of more than 600 beds (24 in-hospital), efficient bioanalytical laboratories and experienced scientific staff, Celerion offers one of the most experienced clinical pharmacology research networks in the industry.