Director, Visual Function (US Remote)

MERIT CRO, Inc.•Madison, WI

7d•Remote

About The Position

MERIT CRO, Inc. is a global clinical trial endpoint expert specializing in multiple therapeutic areas. We’re committed to making a difference and are seeking talented people to join our team. Collaboration and customer focus are at the core of everything we do. We value diversity and are interested in people with drive, dedication, and creative problem-solving skills. We offer flexible schedules and remote opportunities. 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 the end of study activities including document archival. The role supervises 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. Primary functions include overseeing the team performing activities associated with management of ophthalmic clinical trials including monitoring data review and quality control functions; providing training and support for clinical sites, reading centers, and clients using EXCELSIOR; and ensuring study compliance for the lifecycle of a project. Additionally, the Director leads departmental quality initiatives and works to set and achieve project milestones and departmental goals.

Requirements

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.
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.
Must be able to project a professional attitude and image appropriate for the work environment.
Ability to participate and contribute in a team environment as a team leader.
Oral and written communication is clear, concise, and effective.

Nice To Haves

Experience in clinical trial project management with another company/organization within the industry is preferred but not required.

Responsibilities

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.
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
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
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
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
Comply fully with company policies and Standard Operating Procedures (SOPs)
Other responsibilities may be assigned as required
Practices and responds with commitment and sensitivity toward satisfying the needs of internal and external customers. Promotes quality and continuous improvement philosophy.
Demonstrates a commitment to maintain a safe, clean, and orderly work area. Promotes and follows safety regulations and actively contributes to work safety.