Manager, Clinical Systems-Records Management

Summary

Join Precision for Medicine as a Manager, Clinical Systems - Records Management! This remote position, available in Hungary, Poland, Romania, Serbia, or Slovakia, offers oversight of a team implementing and maintaining an eTMF system and TMF processes. You will be responsible for successful team execution, providing guidance, and ensuring work prioritization. The role involves planning, implementation, adoption, and maintenance of the eTMF system, as well as staff management. A 4-year college degree or equivalent, 2+ years of people management experience, and eTMF system experience are required. Experience in clinical operations and strategic planning is preferred.

Requirements

• 4-year college degree or equivalent combination of education and experience in information systems or technology
• At least 2+ years direct experience managing people
• Track record of implementing process and standardization for tracking and reporting clinical trials
• Experience with eTMF, Veeva Vault and vendors
• Must be able to communicate effectively in the English language

Responsibilities

• Support the development of efficient implementation and adoption plans
• Oversee a team to drive system and process implementation at the project level
• Initiate continuous improvement efforts, identify, and develop best practices, and enforce standardization throughout system and process implementation
• Ensure procedural documents are prepared, kept up-to-date and meet the needs to a cross functional team of user stakeholders
• Support Business Development activities, such as Proposal responses or participation at Bid Defense meetings related to the eTMF system and TMF process
• Act within an inspection-ready and quality mindset across all activities and represent as needed during internal and external audits
• Support multidisciplinary department initiatives as the primary liaison for internal stakeholders and external partners
• Ensure team members have assigned studies or tasks for appropriate allocation to billable work and fully utilization
• Provide clear and effective guidance to team members in the execution of their responsibilities related to the Records Management processes and standards
• Ensure effective prioritization of work, and team members’ ability to meet expected timelines with quality deliverables
• Meet the highest standards of effective delivery across the team

Preferred Qualifications

• Experienced in industry with expertise in the areas of clinical operations development and strategic planning; experienced with early to late-stage clinical trials
• Demonstrated understanding of the pharmaceutical development process, including regulatory requirements and their impact on the conduct of clinical trials