Source Document Manager

Flourish Research

2d • $85,000 - $95,000 • Remote

About The Position

Flourish Research is actively hiring a remote Source Document Manager. This role involves leading as a subject matter expert in source documentation management, coordinating recruitment, maintaining SOPs, training staff, and driving the implementation of eSource systems. The position requires creating tools, tracking metrics, liaising with vendors, and presenting updates to leadership. The Source Document Manager will also be responsible for creating error-free written documents, performing duties cost-effectively, and representing Flourish Research professionally.

Requirements

• Bachelor’s degree or commensurate experience.
• Minimum of 5 years’ experience in clinical research industry.
• Minimum of 3 years’ experience in building study source documents.
• Extensive eSource system experience (RealTime eSOURCE preferred).
• Consistently demonstrates core values & high proficiency of skills set.
• Experienced with Microsoft office applications (Outlook, Word, and Excel) as well as internet-based applications.
• Detail oriented, organized, self-motivated, able to work independently and on a team, and the ability to stay on task.
• Able to manage and effectively prioritize a high-volume workload.
• Possess excellent interpersonal skills including written and verbal communications.
• Moral and ethical in decision-making and during interaction with investigators and site staff.
• Professional and have a strong work ethic.
• 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.

Nice To Haves

• RealTime eSOURCE experience

Responsibilities

• 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 chart/grafts/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

Benefits

• Health insurance
• Dental insurance
• Vision insurance
• 401(k) with a 100% employer match on the first 4% of employee contributions
• Tuition reimbursement
• Parental leave
• Employee referral program
• Employee assistance program
• Life insurance
• Disability insurance
• Generous PTO plan covering vacation, sick, personal days
• 8 paid holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level