Job Description

This is an exciting opportunity for TMF Quality Project Manager (TMF Lead) role within Records Management department. If you are experienced in TMF management and cross functional collaboration, you are motivated and have strong communication skills, please review and apply!

TMF Quality Project Manager

Serve as the liaison between Records Management and user departments regarding Trial Master Files Apply Records Management expertise to provide project related assistance across multiple project(s) and project teams. Ensure all work is conducted in accordance with Standard Operating Procedures (SOPs), policies, practices, good clinical practices, applicable regulatory requirements, and meets quality and timeline metrics. May be required to ensure that project timelines are met and facilitate the orderly scanning, transfer, retention, and disposition of various project-related and business records. May lead teams functionally, where assigned, including awareness of scope of work, budget, and resources. May manage a team of records management or technically-related staff working in support of projects within a designated office, country, or region.

Essential Functions

• 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 project(s), 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;
• May 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, as appropriate or as requested;
• May lead teams functionally, where assigned, including awareness of scope of work, budget, and resources;
• May maintain accurate trackers and systems to control records and box inventory;
• May coordinate transfer, recall, and disposition of records to commercial records storage centers;
• May 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;

Qualifications

• Bachelor's Degree in health care or other scientific discipline or equivalent combination of education, training and experience.
• 3 years’ experience working as TMF QPM or relevant TMF management role
• Equivalent combination of education, training and experience.
• 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 a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time.
• May require occasional travels
• Candidate with less experience will be also considered as Records Management Specialist

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.