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;
Train team members on records management tasks, policies, and procedures;

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
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.
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.

Quality Project Manager, Bulgaria, Romania

Key skills