TMF Quality Project Manager (Poland)

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.

• Bachelor's Degree in health care or other scientific discipline or equivalent combination of education, training and experience
• 3 years’ experience working as TMF Quality Project Manager 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
• Strong 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
• Position requires significant writing and keyboarding involving repetitive motions and prolonged sitting
• May require occasional travels
• Candidate with less experience may be considered as Records Management Specialist

• Serve as the liaison between Records Management and user departments regarding Trial Master Files
• Apply Records Management expertise to provide project related assistance across complex and multiple projects, sites, and project teams
• Ensure project deadlines, commitments, and goals are met by monitoring project’s daily outputs
• Ensure all work is conducted in accordance with Standard Operating Procedures (SOPs), policies, practices, good clinical practices, applicable regulatory requirements, meets quality and timeline metrics
• Serve as primary contact for internal/external clients
• Coordinate the retrieval of records requested by users and prepare closed studies for transfer to final destination within the agreed timelines
• Assist management with the implementation of plans, cost proposals, and resource projections for records management projects
• Train team members on records management tasks, policies, and procedures
• Collect data and assist in the preparation of statistical reports for management of record center operations
• Lead teams functionally, including awareness of scope of work, budget, and resources
• Maintain accurate trackers and systems to control records and box inventory
• Coordinate transfer, recall, and disposition of records to commercial records storage centers
• Oversee disposal of obsolete records and ensure efficient maintenance of records storage space, supplies, and equipment
• Maintain records center security to protect record integrity by ensuring compliance to SOPs

IQVIA maintains a zero tolerance policy for candidate fraud. All information and credentials submitted must be truthful and complete. False statements, misrepresentations, or material omissions during recruitment will result in disqualification or termination in accordance with applicable law.