Associate Director of Project Management (US Remote)

MERIT CRO, Inc.•Madison, WI

3d•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. MERIT is seeking a full-time Associate Director of Project Management to oversee daily operations of the project management group and accurately and competently administer activities regarding assigned studies. Responsible for overseeing all study activities including: study start up; training activities; creating and distributing study documents; vendor management; regulatory documentation; maintaining study files; coordination of site correspondence and activities; and the end of study activities including document archival. Primary functions include overseeing the team of Project Managers performing activities associated with management of clinical trials including; monitoring data review and quality control functions; providing training and support for clinical sites, reading centers, and clients using EXCELSIOR™; ensuring study compliance for the lifecycle of a project. Additionally, this position leads departmental quality initiatives and ensures that projects/department milestones/goals are met and adheres to MERIT and/or study specific procedures and Good Clinical Practices (GCP).

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 five (5) 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 personnel
Develop/implement training programs
Participate in development, recommendations and administration of project management standard operating procedures
Interview and contribute to final hiring decision of new PM staff
Monitor workload across projects and ensure appropriate coverage
Communicate project support needs to upper management
Monitor employee performance and routinely provide constructive feedback and coaching
Manage corrective, disciplinary, or termination activities including notification to Executive Team and Human Resources.
Act as a resource for other Project Management team members and provides guidance for project related inquiries.
Monitor study start up activities
Monitor development and review EXCELSIOR™ configuration
Participate and lead project specific meetings and communications with sponsors, clinical sites and CROs
Develop and provide study specific training for reading centers and Project Management team members
Provide training and guidance for sponsor and CRO personnel with access to projects in EXCELSIOR™
Participate and/or assign representatives for client and sponsor meetings
May serve as project manager for studies
Provide ongoing technical and imaging support to clinical sites, reading centers and sponsor/CRO personnel
Review and respond to customer support and complaint tickets in the helpdesk application
Provide expertise related to imaging equipment and services
Collaborate with internal IT support for qualification and validation of COTS applications
Monitor image receipt for multiple projects to meet sponsor expectations for turnaround times and quality review
Monitor development and approval of procedures for image processing and data quality review
Manage study queries and problematic data submissions
Work with the Imaging team to identify study needs and develop materials to support those working on studies
Monitor Data reconciliation activities
Monitor turnaround times for data lock activities
Coordinate with reading center personnel
Understand the EXCELSIOR™ product, protocol and conduct of clinical trials in sufficient detail to be able to adequately discuss tasks with study team members
Provide guidance and training to sponsors, CROs and clinical sites on the use of EXCELSIOR™, including software functionality and technical support
Ensure the internal team is appropriately trained in the use of EXCELSIOR™, and if required, provide additional training support and development
Review, categorize, and respond to customer support and complaint tickets in the helpdesk application
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 safe, clean and orderly work area.
Promotes and follows safety regulations and actively contributes to work safety.