This position is responsible for overseeing and managing the overall conduct and operational activities of one or more multi-center clinical research studies. Position is responsible for managing all aspects of the study including internal, site and data management.
Coordinates, manages and performs activities related to clinical research projects:
Oversees and participates in the development, implementation and maintenance of protocols, consent forms, case report forms, and study specific materials for assigned projects.
Manages all aspects of assigned clinical studies/projects to ensure studies are completed in compliance with protocol, SOPs, FDA regulations and ICH/GCP guidelines.
Assists in generation of IND, annual reports and other study status reports.
Provide support to Investigators, Study Coordinators and other appropriate site personnel regarding study workflow, overcoming obstacles and general questions regarding study conduct.
Collaborates with Operational teams when applicable to ensure effective and efficient study implementation and management as it relates to operational processes.
Coordinates initial and ongoing protocol and CRF training.
Participates in data management activities to ensure the generation of accurate, complete and consistent clinical data for individual clinical trials. Participates in creation of study specific data management plans.
Participates in case report form and clinical database management system development process for individual clinical trials. Assists in defining logic and edit check mechanisms and in end user testing and documentation processes.
Coordinates and monitors on-site monitoring visits in compliance with study monitoring plan with Audit/Monitoring Manager. Participates in creation of study specific monitoring plans.
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.
Assist with the preparation and processing of Serious Adverse Event (SAE) reports as required to meet study-specific requirements.
Other duties as assigned.
Clinical and outcomes research study design
Extensive clinical research knowledge and understanding of clinical trial methodology
GCP, ICH and FDA clinical guidelines
Clinical database applications such as EDC and CTMS
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
Must exemplify our Be The Match Standards
Education and/or Experience:
Bachelor’s degree in scientific or health related field.
Five years of experience directly supporting and/or managing clinical trials according to ICH/GCP/FDA guidelines.
Internal Number: 190000GJ
About Be The Match
Be The Match® is the trusted leader in the field of cellular therapy. We never lose sight of our purpose—delivering cures for blood cancers. From the moment a patient is diagnosed, we are there every step of the way; helping their doctor find a donor, delivering life-saving cells to the patient’s bedside, and supporting patients through recovery and survivorship.
With over 30 years of experience, we are the trusted leader in advancing the science of transplant, conducting ground-breaking research and providing vital services for patient families when they need them most.
As the world’s largest registry and hub of a global network, our partners count on us to develop innovative solutions to improve transplant and fuel collaborative relationships essential to saving lives.