IQVIA
TMFQualityProjectManager(Bulgaria&Romania)
“TMF Quality Project Manager (Bulgaria&Romania) at IQVIA. Skills: TMF management, Cross-functional collaboration, Records Management. Serve as liaison between Records Management and user departments regarding Trial Master Files. Provide project related assistance across multiple project(s) and project teams”
What You'll Achieve.
Meets quality and timeline metrics
Industry & Context.
Ability to perceive and analyse problems, develop solutions, and make sound decisions
Position requires a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time, May require occasional travels
What They're Looking For.
Must Have
3 years’ experience working as TMF QPM or relevant TMF management role, Advanced knowledge in Records Management or technically-related areas, International Conference on Harmonization (ICH), Good Clinical Practice (GCP), relevant local laws and applicable regulatory guidelines, Experience in EAC phasing, scope and budget review for TMF function, General knowledge of computer technology and software programs, organizational, planning, and decision making skills, Excellent oral and written communication skills including good command of English language, Ability to perceive and analyse problems, develop solutions, and make sound decisions, Ability to lead others, Ability to establish and maintain effective working relationships with internal and external clients, Ability to achieve productivity despite time pressure constraints, Ability to handle multiple tasks and projects within defined timelines and balance competing priorities
What You'll Do.
Serve as liaison between Records Management and user departments regarding Trial Master Files
Provide project related assistance across multiple project(s) and project teams
Ensure work conducted in accordance with SOPs
good clinical practices
applicable regulatory requirements
and meets quality and timeline metrics
and disposition of records
Lead teams functionally
Manage a team of records management or technically-related staff
Coordinate retrieval of records requested by users
Prepare closed studies for transfer
Assist management with implementation of plans
and resource projections
Train team members on records management tasks
Collect data and assist in preparation of statistical reports
Maintain accurate trackers and systems to control records
and disposition of records
Oversee disposal of obsolete records
Ensure efficient maintenance of records storage space
Maintain records center security to protect record integrity
How You'll Work.
Team & Collaboration
Serve as the liaison between Records Management and user departments; Cross functional collaboration; Establish and maintain effective working relationships with internal and external clients
Communication Scope
Excellent oral and written communication skills; Good command of English language
Process & Methodology
Project related assistance across multiple project(s), Ensure project deadlines, commitments, and goals are met, Awareness of scope of work, budget, and resources
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