Description
Job Title: Project Set Up Manager
Department: Study Set Up
Location: Hybrid, Rochester NY
Hours Per Week: 40
Schedule: Days; Monday – Friday
SUMMARY
As a member of our Clinical Trials Study Management (CTSM) team, the Project Set-Up Manager works collaboratively with Clinical Trials clients, Clinical Trials 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.
RESPONSIBILITIES
- 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
- 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.
- 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.
- Identify and resolve issues/requests in a timely manner per service and metric guidelines; following Standard Operating Procedures for escalations, change control and communication.
- Deliver accurate and timely study data during execution by reviewing and implementing approved study amendments.
- Perform successful study closure by providing study setup documents to Archivist.
- 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.
- 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.
REQUIRED QUALIFICATIONS
- Minimum of 3 years experience working in a clinical trials, laboratory, healthcare setting, or military project management required
PREFERRED QUALIFICATIONS
- Bachelor’s degree strongly preferred
- Excellent verbal and written communication skills required.
- Computer proficiency required; familiarity with relational databases and reporting tool strongly preferred
- Ability to multi-task and prioritize workload required
- Intermediate excel skill set preferred
- Critical thinking and ability to problem-solve
PHYSICAL REQUIREMENTS: S - Sedentary Work - Exerting up to 10 pounds of force occasionally Sedentary work involves sitting most of the time, but may involve walking or standing for brief periods of time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
PAY RANGE: $60,500.00 - $85,000.00
The listed base pay range is a good faith representation of current potential base pay for successful applicants. It may be modified in the future. Pay is determined by factors including experience, relevant qualifications, specialty, internal equity, location, and contracts.
