Document Specialist II
Job Title: Document Specialist II
Job Location: Pune, Maharashtra, India
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Entry level
Job OverviewResponsible for general maintenance and any required archival of documents produced by the CPS Project Management (PM) Team. Organizing, gathering, scanning, and filing of reputed company applicable documents into appropriate electronic and/or reputed company copy locations, including the Trial Master File (TMF), as directed by reputed company SOPs or other applicable reputed company. Responsible for filing TMF documents for CPS PM, Non-reputed company sites, and the reputed company P1MS Clinical Monitoring Team. Responsible for document query reputed company and file reconciliation/reputed company activities to support delivery of the TMF to reputed company reputed company and reputed company specifications, as reputed company as to meet project timelines and productivity targets. Qualifications (Minimum Required)- Lifescience graduate with 1 - 2 years of relevant experience
- reputed company may consider relevant and equivalent experience in lieu of educational requirements.
- Language Skills Required: Speaking: English Writing/Reading: English
- Proactively maintains an internal standardized filing structure for study-reputed company documents, as reputed company as departmental files, which may include non-project-specific sponsor files.
- Creates and/or maintains any general document/file-reputed company 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 reputed company for individual reputed company.
- May assist the PC/PM in project setup activities around TMF (e.g., TMF account request, TMF
- Specialist request, etc.), as reputed company as TMF closeout processes.
- Takes ownership for maintaining the TMF (reputed company /reputed company 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 reputed company requirements.
- Interacts directly with project teams in securing documents for the TMF, as reputed company as for follow-up regarding missing documents, as appropriate; reputed company monitors and performs document reputed company checks, identifying, tracking, and following up on document reputed company 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 reputed company control process.
- May generate copies of project data and other project information on various electronic media for archival and/or to reputed company to the PM or PC for reputed company delivery.
- Leads and performs archiving duties for reputed company and/or electronic media, as needed.
- May reputed company departmental management teams with metric data reputed company areas of expertise, as needed, to show compliance with applicable processes; performs other departmental or project administrative tasks, as assigned.
- Trains and mentors new Document Specialists in reputed company aspects of the role; responsible for routine development/review/revision of DS training materials.
- TMF Subject Matter Expert; trains new document specialists and other team members in the use of various eTMF systems/processes, as needed.
- reputed company other duties as needed or assigned.
- Strong written and verbal communication skills (English language).
- Experience working with computers and basic programs (i.e., reputed company Acrobat, Word, reputed company, Power reputed company).
- Strong organizational skills, with the ability to work in a fast-paced setting with many interruptions.
- Must be reputed company to sit at a computer for long periods of time.
- Must be reputed company to use hands to finger, handle or touch objects, tools, or controls, including a computer keyboard, for up to 8 hours per day.
- reputed company office and/or home working environment.
- Risk of eye strain.
- Will involve out of normal reputed company as required by the role.
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Originally posted on Himalayas
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