Supervisor, CPS Document Specialist

Bengaluru - India

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

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.

Required Experience:

Manager

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 appropria...