Source Document Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Serve as a subject matter expert in source documentation management for Flourish Research.

• Collaborate with HR to recruit and conduct interviews for regional Source Creation Specialists.

• Oversee the source creation Standard Operating Procedures (SOP) and processes for the team and sites.

• Educate Source Creation Specialists in building, reviewing, and maintaining study source documentation.

• Develop tools and offer guidance to monitor and manage workload effectively.

• Lead the implementation of the eSource system at newly acquired sites.

• Participate in site integration meetings, provide updates on progress, and follow up on action items.

• Monitor and report on site integration metrics while identifying potential obstacles.

• Train site personnel and investigators on how to update study source and enter data accurately.

• Develop training materials and tools, maintaining the training library.

• Supervise regional Source Creation Specialists to ensure consistent processes across various sites.

• Organize and facilitate regular team meetings and individual one-on-ones.

• When necessary, create study source documents that comply with Flourish SOPs.

• Resolve issues with site management, staff, and Source Creation Specialists.

• Escalate significant or critical matters to site management and leadership.

• Coordinate with vendor support staff to troubleshoot issues and provide constructive feedback.

• Design charts, graphs, and slides for quarterly leadership updates and present materials as required.

• Maintain consistent communication with the team and department leadership.

• Safeguard the confidentiality of sponsor and Flourish trade secrets.

• Produce error-free written documents and reports.

• Execute duties in a timely and cost-effective manner.

• Represent Flourish Research professionally during interactions with staff, clients, and vendors.

• Take on additional responsibilities as assigned by management.

⛳️ Requirements

• A Bachelor's degree or equivalent experience.

• At least 5 years of experience in the clinical research field.

• A minimum of 3 years of experience in creating study source documents.

• Extensive experience with eSource systems, preferably RealTime eSOURCE.

• Proficiency in Microsoft Office applications, including Outlook, Word, and Excel.

• Familiarity with internet-based applications.

• Willingness to travel up to 50% of the time.

• Capability to work remotely with daily computer usage.

• Flexibility to work occasional nights and weekends.

• Ability to lift up to 25 pounds, and occasionally more than that.

• Must have a valid driver's license and daily access to a vehicle.

• Detail-oriented, organized, self-driven, and capable of working independently as well as in a team.

• Aptitude for managing and prioritizing a high-volume workload.

• Strong written and verbal communication skills.

• Ethical decision-making skills when interacting with investigators and site staff.

• A high level of professionalism and a strong work ethic.

• Willingness to adapt and take on additional tasks as needed.

• Problem-solving skills while collaborating across departments.

• Ability to develop and execute departmental initiatives.

• Capacity to identify and implement process improvements.

• Skill in building and nurturing relationships across teams.

🏝️ Benefits

• Health insurance coverage.

• Dental insurance coverage.

• Vision insurance coverage.

• 401(k) plan with a 100% employer match on the first 4% of employee contributions.

• Tuition reimbursement options.

• Parental leave benefits.

• Employee referral program.

• Employee assistance program.

• Life insurance coverage.

• Disability insurance coverage.

• Generous paid time off plan encompassing vacation, sick, and personal days.

• 8 paid holidays throughout the year.

• A supportive and collaborative work environment.

• Abundant opportunities for growth and advancement.

• Commitment to equal employment opportunities and reasonable accommodations.