Clinical Project Manager - Remote

Position Summary
Please apply online using a laptop or desktop computer.
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. This is a remote position (US).
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Accountabilities
Coordinates, manages, and performs activities related to clinical research projects:

• 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.
• Assists in generation of IND, annual reports, and other study status reports.
• 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.
• 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.
• Oversees and participates in the development, implementation and maintenance of protocols, consent forms, case report forms, and study specific materials for assigned projects.
• Collaborates with Operational teams when applicable to ensure effective and efficient study implementation and management as it relates to operational processes.
• 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.
• Manages all aspects of assigned clinical studies/projects to ensure studies are completed in compliance with protocol, SOPs, FDA regulations and ICH/GCP guidelines.
• Other duties as assigned.
• Coordinates initial and ongoing protocol and CRF training.
• Provide support to Investigators, Study Coordinators, and other appropriate site personnel regarding study workflow, overcoming obstacles and general questions regarding study conduct.

Required Qualifications
Knowledge of:

• Project management
• Medical terminology
• Quality assurance
• GCP, ICH and FDA clinical guidelines
• Clinical database applications such as EDC and CTMS
• Extensive clinical research knowledge and understanding of clinical trial methodology
• Clinical and outcomes research study design

Ability To

• Show strong interpersonal, analytical, and organizational skills
• Commit to up to 10% overnight travel
• Work independently with minimal oversight as well as actively contribute to project teams
• Demonstrate advanced oral and written communication
• Demonstrate word processing, spreadsheet, and PowerPoint skills
• Exhibit independent problem solving and proven project management skills
• Effectively interact with a variety of individuals
• Manage multiple tasks
• Show exceptional attention to detail, accuracy and recordkeeping

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.

Be The Match offers regular, full-time employees medical, dental, vision, life and disability, accident/critical illness/hospital, well-being, legal, identity theft and pet benefits. Retirement, paid time off/holidays, leave and incentive plans are also offered to eligible employees. Please reference this link for more information: Be The Match Benefit Information
Additional Information

• Number of Openings: 1
• Job Family: Business Services
• Pay Basis: Yearly
• Driver Policy: No
• Schedule: Full-time
• Career Level: 6
• Career Category: Established Leader / Established Professional