Supervisor, CPS Document Specialist

Summary of Responsibilities:

• Performs supervisory duties for Document Specialists (DSs) including, but not limited to, interviewing, hiring, training, developing, performance evaluation, intervention, discipline, and discharge.

• Organizing, gathering, scanning, and filing of all applicable documents into appropriate electronic and/or paper copy locations, including the Trial Master File (TMF), as directed by Fortrea SOPs or other applicable directive.

• Responsible for filing TMF documents for CPS PM, Fortrea and non-Fortrea sites, and the Fortrea PIMS Clinical Monitoring Team.

• Responsible for document query generation and file reconciliation/resolution activities to support delivery of the TMF to client quality and integrity specifications, as well as to meet project timelines and productivity targets.

• Line management and/or oversight responsibility for the recruitment, training, utilization, development, performance review, intervention, discipline, and discharge of assigned personnel, including creation and coordination of training, development, and support networks.

• Responsible for driving routine development/review/revision of DS training materials. May train other non-DS team members in the use of various eTMF systems/processes, as needed.

• Drives TMF optimization through continuous improvement initiatives.

• TMF Subject Matter Expert; serves as TMF ambassador for CPS within the CDCS organization. Acts as primary point of contact for TMF-related client and internal inquiries, including participation in RFI/RFP submittal and may include bid defense.

• Ensures and coordinates proactive support for TMF inspection readiness and leads the resolution of QA or sponsor audits by identifying and implementing corrective actions to TMF related findings.

• Engages key stakeholders in representing CPS interests in the development and maintenance of SOPs, business process, and systems.

• Demonstrates cost awareness, understands the financial impact of their decisions.

• Creates and/or maintains any general document/file-related tracking forms and/or spreadsheets, as applicable.

• Gathers, organizes, scans, and ships project documentation, as required.

• Assists in the review and finalization of the TMF Plan and Index for individual projects, as well as Expected Document List review/reconciliation throughout assigned projects.

• Takes ownership for maintaining assigned TMFs (Fortrea /Client systems) by working with applicable project team members to retrieve, file, and upload documents in accordance with applicable project milestones/timelines, SOPs, policies, system, and client requirements.

• Interacts directly with project teams in securing documents for the TMF, as well as for follow up regarding missing documents, as appropriate; actively monitors and performs document quality checks - identifying, tracking, and following up on document quality issues with relevant staff members.

• Works with the PM/PC involved project teams, and applicable business partners for reconciliation of the TMF as part of the quality control process.

• May provide departmental management teams with metric data within areas of expertise, as needed, to show compliance with applicable processes; performs other departmental or project administrative tasks, as assigned.

• And all other duties as needed or assigned.

Qualifications (Minimum Required):

• High School Diploma or equivalent at minimum.

• BS or equivalent in scientific field preferred; experience may be substituted for education.

• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

• Fluent in English, both written and verbal.

Experience (Minimum Required):

• Strong written and verbal communication skills (English language).

• Experience working with computers and basic programs (i.e., Adobe Acrobat, Word, Excel, Power Point).

• Strong organizational skills, with the ability to work in a fast-paced setting with many interruptions, on multiple projects/tasks simultaneously.

• Minimum of 5 years of experience TMF focused leadership/management role.

Preferred Qualifications Include:

• BS or equivalent in scientific field preferred; experience may be substituted for education.

Physical Demands/Work Environment:

• Must be able to sit at a computer for long periods of time.

• Must be able to use hands to finger, handle or touch objects, tools or controls, including a computer keyboard, for up to 8 hours per day.

• Standard office and/or home working environment.

• Risk of eye strain.

• Will involve out of normal office hours as required by the role.

Learn more about our EEO & Accommodations request here.