Clinical Monitoring Manager

POSITION TITLE: Clinical Monitoring Manager

DEPARTMENT: Ora Europe

LOCATION: UK, Italy or Spain

Ora Values the Daily Practice of …

Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor

At Ora, we are building the future of ophthalmic clinical research. As the world’s leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market. Over the past 45 years, our expert teams have helped earn more than 85 new product approvals. Ora's pre-clinical and clinical models, unique methodlogies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects. Today, our team continues to expand across the globe, with over 600 employees across North America, Europe, Asia, and Latin America.

The Role:

This position provides direct oversight to members of the monitoring team including CRAs and/or Lead CRAs and may be called upon to interact independently with clients and to assist in wider company tasks. The Clinical Monitoring Manager is responsible for ongoing evaluation of current and upcoming work to evaluate the resource needs of the department to ensure the monitoring team is achieving utilization targets. In addition, the individual serving in this role understands how to assess the qualifications of monitors in order to be able to deploy a highly skilled and properly educated team. This position works collaboratively with cross-functional teams and independently to support the clinical trial activities.

What You’ll Do:

• Create, update, implement and conduct onboarding training to ensure direct reports are qualified to conduct duties in an efficient and timely manner
• Track ongoing training compliance to confirm direct reports are appropriately trained within expected timeline(s)
• Suggest additional strategies to ensure direct reports are knowledgeable on current industry trends and information
• Actively participate in the processes to recruit, interview and select CRA and Lead CRA candidates
• Utilize technology and database information to project resourcing needs. Regularly maintain the resourcing database for direct reports and provide hiring decisions to senior management
• Utilize metrics and key performance indicators to manage individual and team performance. Implement action plans to address potential barriers to achieving expected performance
• Attend on-site visits to ensure CRA compliance with study-related and company processes. Implement action plans for any required improvements
• Oversee compliance for data entry into CTMS and regulatory document submission into the trial master file
• Approve time reporting and expenses for direct reports
• Participate in study budget review meetings and complete monitoring budget assessments
• Ensure career development goals of each direct report are met through regular meetings, performance reviews/appraisals and assisting staff in accessing career development opportunities
• Provide mentorship, coaching and work direction to direct reports
• Document and follow, to resolution, any actionable issues requiring a correction action plan
• Lead and/or contribute to monitoring department and cross-functional company initiatives
• Travel Requirements up to 25%.
• Adhere to all aspects of Ora’s quality system.
• Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora’s data integrity & business ethics and regulatory requirements.
• Clear and sustained demonstration of Ora’s values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors.
• Responsibilities may differ from the above based on the specific needs of the business.