Clinical Project Manager, CRO Services (Finance)
Job Description
POSITION SUMMARY:
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.
ACCOUNTABILITIES:
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.
REQUIRED QUALIFICATIONS:
Knowledge of:
- Clinical and outcomes research study design
- Extensive clinical research knowledge and understanding of clinical trial methodology
- Project management
- Medical terminology
- Quality assurance
- GCP, ICH and FDA clinical guidelines
- Clinical database applications such as EDC and CTMS
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.
- Five years of experience directly supporting and/or managing clinical trials according to ICH/GCP/FDA guidelines.
POSITION SUMMARY:
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.
ACCOUNTABILITIES:
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.
REQUIRED QUALIFICATIONS:
Knowledge of:
- Clinical and outcomes research study design
- Extensive clinical research knowledge and understanding of clinical trial methodology
- Project management
- Medical terminology
- Quality assurance
- GCP, ICH and FDA clinical guidelines
- Clinical database applications such as EDC and CTMS
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.
- Five years of experience directly supporting and/or managing clinical trials according to ICH/GCP/FDA guidelines.
