Manager, Clinical Systems - Records Management

Precision for Medicine is hiring a Manager, Clinical Systems - Records Management to join our team, candidates can work remotely in Hungary, Poland, Romania, Serbia or Slovakia.

Position Summary:

Reporting to the Records Management Head, the Manager of Clinical Systems - Records Management provides oversight, direction and solutions to team members in the implementation, adoption and maintenance of eTMF system and TMF processes. Under the direction of the Records Management Head, the Manager is responsible for successful execution of the work of the team members implementing the eTMF system and TMF processes, and with project teams using the eTMF system and following the TMF processes and standards. The Manager is responsible for overseeing the Records Management team, providing guidance, coaching, work prioritization and goal performance discussions.

Essential functions of the job include but are not limited to: 

• eTMF System and process Planning, Implementation, Adoption & Maintenance (70%)
• 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.

Staff Management (30%)

• 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.

Qualifications:

Minimum Required:

• 4-year college degree or equivalent combination of education and experience in information  systems or technology

Other Required:

• 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

Preferred:

• 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

Skills: 

• Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines
• Excellent verbal and written communication skills
• Excellent problem-solving skills

Competencies:

• Proven ability to think critically and creatively to solve complex problems and address long-range goals and objectives
• Independently motivated and detail oriented
• Sound judgment/decision making
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients
• Ability to lead and inspire excellence within a team
• Ability to work in a team environment, meet deadlines and prioritize and balance work from multiple individuals
• Results oriented, accountable, motivated, and flexible