Study Set-Up Project Manager
As a member of our Clinic Trials Study Management (CTSM) team, the Clinical Trials Set-Up Project Manager (SPM) works collaboratively with CT clients, Project Managers and key stakeholders to manage the process of designing and launching clinical trial studies. In accordance with approved Global Laboratory Specifications Document (GLSD), coordinate standardized set-up process across protocols and departments to ensure studies are delivered on-time, on-budget and as contracted. Provide friendly, engaging and responsive client services from GLSD sign-off to study set-up completion.
LOCATION:ACM Global Laboratories - 158 Wallace Way (Rochester Tech Park)
- Bachelor's Degree
- 2 years of experience supporting clinical trials, labs or health care setting
- Excellent interpersonal, organization and management skill
- Client Management. Guarantee client satisfaction by providing exceptional service through a consistent customer centric approach, focus on precision delivery and flexibility to meet customer expectations. Maintain positive working relationships with CT clients, Business Development Directors, Clinical Trials Study Management and key stakeholders.
- Study SetUp. Maintain a general working knowledge of Food & Drug Administration (FDA), Medical & Healthcare Regulatory Agency (MHRA), New York State Department of Health (NYSDOH), Good Clinical Practice (GCP), ICH and other pertinent regulations.Perform successful study closure by providing study setup documents to Archivist. Deliver accurate and timely study data during execution by reviewing and implementing approved study amendments. Identify and resolve issues/requests in a timely manner per service and metric guidelines; following Standard Operating Procedures for escalations, change control and communication. Develop the database design requirements which include configuration (project specific kit contents, laboratory events, requisitions, and medical reports), programming for full protocols and protocol amendments, and developing and maintaining client design standards as applicable. Prepare study for successful initiation by reviewing the GLSD, completing all necessary study setup documentation/forms (including sites), priming systems, and coordinating setups with other departments for multiple, multi-region complex and non-complex clinical trials studies at one time.
- Teamwork. Assist in process improvement within the Clinical Trials Project Management team by developing methods to improve productivity, service, quality, cost savings, policies & procedures. Participates in Clinical Trial meetings and task forces to develop standardization in the set up process across protocols and departments. Participate in training to maintain relevant working knowledge of Clinical Trials. Perform other duties as assigned.