Study Monitor Jobs in Middleton, WI (NOW HIRING)

Director of Visual Function

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES: (Other duties may be assigned.)

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
• Project close out activities
  • 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

The following are the essential functions of the position but are not all-inclusive.

• 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.

QUALIFICATION REQUIREMENTS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and Experience:

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.

Other Skills and Abilities:

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.

Licenses or Certifications Required:

None.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is required regularly to use hands; to touch, finger and grasp, handle or feel, with repetitive motions, and talk or hear. The employee is frequently required to stand, walk, and sit. The employee is required occasionally to reach with hands and arms, stoop, crouch, kneel and climb. The employee must frequently lift and/or move up to ten pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job

Benefits Offered:

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

MERIT CRO, Inc. is an equal opportunity employer, and we are committed to hiring a diverse and talented workforce It is the employment policy and practice of MERIT CRO, Inc. to recruit and hire qualified employees without discrimination based on race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, national origin, ancestry, citizenship status, age, mental and physical disability, pregnancy, medical condition, genetic information, political affiliation, union membership, status as a parent, marital status, military or veteran status, or other classes protected by applicable law, and to not discriminate concerning compensation and opportunities for advancement, including upgrading, promotion, and transfers. We will provide reasonable accommodation to qualified individuals throughout the application, interviewing, and employment process. If you require reasonable accommodation, please contact us.