POSITION SUMMARY:
This position is responsible for assisting with the design, planning and execution of clinical trial program activities for the Blood and Marrow Clinical Trials Network (BMT CTN). This role will assist with coordination of operations and milestone execution among stakeholders while ensuring clear communication. Assists or is responsible for leading cross-functional clinical/working teams. This position can be remote (US) or hybrid. #LI-Remote #LI-Hybrid
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ACCOUNTABILITIES:
Coordinates, manages and performs activities related to clinical research network projects:
Manages BMT CTN projects and program activities under direction of clinical program manager
Oversees, organizes and participates in virtual, in-person and hybrid meetings and training sessions
Provide support to Investigators, Study Coordinators and other appropriate site personnel regarding study workflow, overcoming obstacles and general questions regarding BMT CTN conduct.
Collaborates with Operational teams when applicable to ensure effective and efficient project implementation and management as it relates to operational processes.
Facilitates communication among internal and external stakeholders
Provides accurate progress reports on network activities by writing assigned portions and coordinating completion by other stakeholders
Participates in data management activities to ensure the generation of accurate, complete and consistent data for BMT CTN metrics reporting and for individual clinical trial reports.
Tracks progress of studies/projects and initiates appropriate actions to resolve barriers or promote successes. Identifies and performs study related problem-solving internally and at trial sites.
Other duties as assigned.
REQUIRED QUALIFICATIONS:
Knowledge of:
Clinical and outcomes research study design
Project management
Medical terminology
GCP, ICH and FDA clinical guidelines
Ability to:
Demonstrate advanced oral and written communication
Exhibit independent problem solving and proven project management skills
Show strong interpersonal, analytical and organizational skills
Manage multiple tasks
Effectively interact with a variety of individuals
Work independently with minimal oversight as well as actively contribute to project teams
Show exceptional attention to detail, accuracy and recordkeeping
Demonstrate word processing, spreadsheet and PowerPoint skills
Commit to up to 10% overnight travel
Education and/or Experience:
Bachelor's degree in scientific or health related field.
Three years of experience managing clinical trials or clinical consortiums according to ICH/GCP/FDA guidelines.
PREFERRED QUALIFICATIONS: (Additional qualifications that may make a person even more effective in the role, but are not required for consideration)
Experience with transplant and/or cellular therapy trials
Experience conducting/managing trials within the BMT CTN
Proof of being up-to-date on COVID-19 vaccination, including a booster when eligible, with acceptable documentation is required for employment. NMDP will consider all requests for medical or religious accommodation.
