Description
The Clinical Operations Manager is responsible for the day-to-day management of an assigned team of both permanent and contracted staff (e.g., Clinical Research Associates (CRA)/(cCRA)) and other Clinical Operations Support personnel) overseeing their performance and training, ensuring adequate monitoring and support team resources, allocating resources to projects, identifying quality issues related to Clinical Operations activities and establishing action plans to address them.
Requirements
More specifically, the Clinical Operations Manager must:
- Ensure that clinical monitoring activities of their assigned team are performed to the Sponsor’s satisfaction, ensuring timely quality deliverables, within budget, and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices, and study-specific requirements.
- Oversee the performance of their direct reports, ensuring they are meeting performance objectives and taking appropriate remedial actions as required. Implement professional development and performance evaluations.
- Support the training and development of Clinical Operations personnel within their remit, providing coaching and mentoring. Ensure team members’ consistent use of study tools and training materials.
- Assist in developing and delivering training for Clinical Operations personnel.
- Track Clinical Operations metrics and monitor adherence to targets (e.g., number of site visits performed, utilization, and timeliness to complete deliverables such as site visit report finalization, follow-up letters, timesheets, expense reports and required training.)
- Ensure monitoring expenses are compliant with policy and aligned with established guidelines.
- Perform Quality Assessment Visits (QAV) with CRAs.
- Identify quality issues related to Clinical Operations activities through project meetings, site and team communications, site visit reports and follow-up letters, QAVs, and quality assurance audit findings. Summarize findings and establish action plans to bring corrective actions.
- Serve as a point of contact for Clinical Operations personnel and other team members for assigned projects or initiatives.
- Serve as a management contact for sites, project teams, and sponsors when issues related to Clinical Operations and trial management activities must be escalated to ensure communication is maintained and resolution is achieved.
- Assist with assessing and interviewing potential Clinical Operations candidates.
- Drive innovation within Clinical Operations by identifying opportunities to optimize workflows and enhance efficiency, quality, and scalability, while supporting the adoption of emerging technologies and AI-enabled solutions to improve study execution.
- Foster a culture of innovation, collaboration, and proactive problem-solving across Clinical Operations teams.
- May conduct on-site or remote monitoring visits to offer support to project teams.
- May perform site visit report review and track site visit report metrics to ensure compliance.
- May review or provide input to Clinical Operations plans and tools.
- May review and provide feedback on related SOPs and Tools during updates.
- May support site survey activities to assess site satisfaction and synthesize insights in support of continuous improvement.
Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training.
Our company
The work environment
At Indero, you will work with brilliant and driven colleagues. Our values are integrity, commitment and teamwork. We offer a stimulating work environment and attractive advancement opportunities.
As a Clinical Operations Manager, you will be eligible for the following perks:
- Flexible work schedule
- Permanent full-time position
- Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities)
- Ongoing learning and development
About Indero
Indero is a contract research organization (CRO) specialized in dermatology with a team of over 350 employees. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America.
Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
We thank you for your application and please note that only those selected for an interview will be contacted.
only accepts applicants with a work permit for Spain.
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