[Hiring] Director, Visual Function @MERIT CRO, Inc.

Role Description

The Director will manage the daily operations of the Visual Function department, focusing on the tactical aspects of study execution. Responsibilities include:

• Overseeing study activities such as study start up, training activities, creating and distributing study documents, contractor and vendor management, regulatory documentation, maintaining study files, coordination of site correspondence and activities, and end of study activities including document archival.
• Supervising a team responsible for managing ophthalmic clinical trials, monitoring data quality, and ensuring compliance with study protocols and Good Clinical Practices (GCP) throughout the project lifecycle.
• Leading departmental quality initiatives and working to set and achieve project milestones and departmental goals.

Essential Duties and Responsibilities:

• Management Duties:
  • Supervise Project Management and Visual Function Certification personnel.
  • Develop and implement training programs.
  • Recruit, interview, hire, and onboard new team members and organize training sessions to enhance team skills and compliance with industry standards.
  • Oversee the allocation of resources across multiple projects to ensure optimal utilization and budget adherence.
  • Monitor workload across projects and ensure appropriate coverage.
  • Contribute to Management Review Meeting content.
  • Participate in development, recommendations and administration of business policies and standard operating procedures.
  • Lead strategic planning sessions to align project goals with organizational objectives.
  • Implement professional development plans for staff, including Project Managers, to enhance skills and career growth.
  • Conduct annual performance evaluations and provide feedback to improve team effectiveness and individual performance.
  • Manage corrective, disciplinary, or termination activities including notification to Executive Team and Human Resources.
  • Act as a resource for Visual Function team members and provide guidance for project related inquiries.
• Study-Related Duties:
  • Monitor study start up activities.
  • Review study protocols and MERIT's signed agreements to ensure that adequate and appropriate resources are allocated to support studies effectively and efficiently.
  • Offer expert guidance on visual function testing to the configuration and development teams, ensuring that EXCELSIOR™ is optimally configured and functions accurately for study requirements.
  • Oversee the development of visual function testing procedures and review these to ensure compliance with protocol and sponsor requirements for study endpoints.
  • Oversee the setup of clinical sites in EXCELSIOR for certification, examiners, and procedures.
  • Assist with development and review of EXCELSIOR for procedures, certification process/form, and grading form configurations.
  • Ensure all study activities comply with applicable regulatory requirements and internal procedures.
  • Lead and guide Visual Function staff in project specific meetings and communications with sponsors, clinical sites and CROs.
  • Develop and provide procedure and study specific training for MERIT staff.
  • Assign staff to study teams and select representatives for client and sponsor meetings.
• Technical Support:
  • Identify potential study risks and develop mitigation strategies to prevent project delays and other issues.
  • Provide ongoing technical and visual function testing support to clinical sites, reading centers and sponsor/CRO personnel.
  • Oversee the management of customer support and complaint tickets in the helpdesk application.
  • Source and obtain vendor supplied ophthalmic equipment and liaise with vendor representatives.
  • Provide expertise related to visual function testing procedures and equipment.
  • Collaborate with internal IT support for qualification and validation of external software applications.
• Visual Function Testing Workflow:
  • Develop workflows to improve efficiency and reduce turnaround times for data processing and grading.
  • Oversee the management of ophthalmic data receipt for multiple projects to meet sponsor expectations for turnaround times and quality review.
  • Monitor data reconciliation activities.
  • Monitor turnaround times for data lock activities.
  • Coordinate with MERIT staff as needed.
• Software-related Duties:
  • Understand the EXCELSIOR™ product, protocol and conduct of clinical trials in sufficient detail to be able to adequately discuss tasks with study team members.
  • Conduct project-specific user acceptance testing.
  • Ensure MERIT staff are appropriately trained in the use of EXCELSIOR, and if required, provide additional training support and development.
• Other:
  • Comply fully with company policies and Standard Operating Procedures (SOPs).
  • Other responsibilities may be assigned as required.

Qualifications

• Minimum of a Bachelor’s degree in a health related, biological science, computer science, data entry, customer service or business management (or internal work experience).
• A minimum of ten (10) years of clinical trial or project management experience in a related field. Experience in clinical trial project management with another company/organization within the industry is preferred but not required.
• Strong interpersonal and organizational skills, excellent attention to detail, ability to follow direction, assess Company needs and work independently.
• Computer skills to include proficiency in Microsoft Office software and ability to learn Company specific software.
• Ability to participate and contribute in a team environment as a team leader.
• Oral and written communication is clear, concise, and effective.

Requirements

• None.

Benefits

• 401k Retirement Plan
• Health insurance
• Paid (8) Holidays
• Paid Life Insurance and AD&D
• Paid Long Term Disability insurance
• Paid Time Off
• Voluntary Insurance