Source Document Manager

We are actively hiring a remote Source Document Manager.

Shift: Monday-Friday day shift
Location: Remote
FLSA Classification: Exempt
Compensation: $85k-$95k

ESSENTIAL JOB FUNCTIONS:

• Lead Flourish Research as a subject matter expert in source documentation management.
• Coordinate with HR to recruit and interview new regional Source Creation Specialists.
• Maintain the source creation SOP and process for the team and sites.
• Train Source Creation Specialists to build, review, and maintain study source.
• Create tools and provide guidance to track and manage workload.
• Drive implementation of the eSource system at newly acquired sites.
• Attend and participate in site integration meetings to provide status updates and follow-up on action items.
• Track and report on site integration metrics and proactively identify potential roadblocks.
• Train site staff and investigators to update study source and enter data.
• Create training materials and tools to ensure consistency. Maintain training library.
• Manage regional Source Creation Specialists to ensure consistency in processes across sites.
• Schedule and host regular team meetings and 1:1s to foster a healthy team culture.
• Build and create study source documents compliant with Flourish SOPs, when necessary, to support regional Source Creation Specialists.
• Troubleshoot solutions with site management, site staff, and Source Creation Specialists when issues are identified.
• Escalate major or critical issues to site management and leadership.
• Liaise with vendor support staff to resolve issues and provide feedback, offer opportunities for improvement.
• Create charts/graphs/slides to use in quarterly updates to leadership on site progress. Present the materials as needed.
• Maintain an open line of communication on daily with team and department leadership.
• Maintain confidentiality of sponsor and Flourish trade secrets.
• Create error-free written documents and reports (e.g., cover letters, notes-to-file, memos, etc.).
• Perform all duties in a time- and cost-effective manner.
• Represent Flourish Research in a professional and courteous manner (verbal, written and in appearance) when interacting with all staff, clients, and vendors.
• Additional duties assigned by Management.

Requirements

PHYSICAL REQUIREMENTS AND/OR ENVIRONMENTAL FACTORS:

• Work is normally performed remotely.
• Travel required up to 50%.
• Vendor Customer Service.
• Daily computer usage.
• Occasional night and weekend work schedules.
• Ability to properly lift up to 25 pounds and occasionally more than 25 pounds.
• Ability to drive, and daily availability of an automobile.

MINIMUM REQUIREMENTS:

• Bachelor’s degree or commensurate experience.

Experience:

• Minimum of 5 years’ experience in clinical research industry. Minimum of 3 years’ experience in building study source documents.

Knowledge and Skills:

• Must have extensive eSource system experience (RealTime eSOURCE preferred).
• Consistently demonstrates core values & high proficiency of skills set.
• Must be experienced with Microsoft Office applications (Outlook, Word, and Excel) as well as internet-based applications.
• Must be detail-oriented, organized, self-motivated, able to work independently and on a team, and the ability to stay on task.
• Must be able to manage and effectively prioritize a high-volume workload.
• Must possess excellent interpersonal skills including written and verbal communications.
• Is moral and ethical in decision-making and during interaction with investigators and site staff.
• Must be professional and have a strong work ethic.
• Must have the ability to adapt and take on additional tasks as requested.
• Ability to problem-solve while working closely across departments.
• Develops and implements key initiatives in the department.
• Identifies and implements process improvements for increased efficiencies.
• Builds and fosters relationships across teams.