<Minimum Requirements>
■Data Manager I
Able to work directly with the client on the development of all Data Management specifications (including database setup, data cleanup and timelines), and possess a thorough understanding of data cleanup activities. High quality of work and the ability to prioritize appropriately is expected. Excellent intrapersonal and problem solving skills are required.
Bachelor's degree and 4 years of clinical data management experience, or Master's degree and 2 years of clinical data management experience;
Basic knowledge of SAS® in order to execute programs, review logs and perform basic troubleshooting;
Establish/negotiate Data Management project timelines and ensure Data Management milestones are met;
Finalization of all study-related Data Management documents and study data, including coding, assuring quality and completeness;
Positive attitude and healthy working relationship with the project team(s);
Present the role of Data Management at audits, conferences, and bid defense meetings;
Knowledge of the pharmaceutical industry and Federal Regulations regarding electronic records; and
Lead the Data Management activities for multiple clinical trial projects.
■Data Manager II
A position with responsibility for the design and management of projects independently. The employee is experienced enough to propose and develop specifications for new projects, work directly with the client and/or other departments, and serve as a Project Team leader with minimal supervision. Capable of independent interaction with other departments and external data providers on all project issues.
Master's degree or Bachelor's degree and 1 year of experience as a Data Manager;
Provide an ongoing evaluation of expected/projected accuracy and productivity rates of Data Management project tasks, competently identify staffing needs and complete regular utilization reports;
Provide feedback for performance evaluation and competency of team members and assist with skill/career development for other Data Management employees; and
Independently manage the Data Management activities for multiple moderate to large clinical trial projects.
■Senior Data Manager (Step 1)
A senior level position with responsibility for the overall Data Management of project(s) independently. Responsible for overseeing multiple projects and the assigned Data Coordinators and Data Managers, and ensure all work is completed within defined time frames to appropriate quality levels.
Master's degree and at least 2 years of experience as a Data Manager, or Bachelor's degree and at least 3 years of experience as a Data Manager;
Assist in business development activities such as presentations to prospective Sponsors, development of scope of work and cost estimates;
Lead the Data Management activities and perform trial tasks normally outside the Data Manager job responsibilities in response to specific trial needs;
Understand the role of other functional areas within Medpace; and
Manage a Data Management team for positive attitude and healthy working relationship with the Project Teams (internal and external).
■Senior Data Manager (Step 2)
A senior level position with responsibility for the overall Data Management of project(s) independently. Responsible for overseeing multiple projects and the assigned Data Coordinators and Data Managers, and ensure all work is completed within defined time frames to appropriate quality levels.
Master's degree and at least 3 years of experience as a Data Manager, or Bachelor's degree and at least 4 years of experience as a Data Manager.
Lead in the preparation and hosting of external audits (Sponsor or FDA);
Serve as a program data management lead on at least one complex or large set of clinical trials;
Extensively understand the role of other functional areas within Medpace; and
Assist with the development of departmental Standard Operating Procedures.
■Associate Director, Data Management
A senior level position with responsibility for the overall Data Management of project(s) and programs independently. Responsible for overseeing multiple projects and supervising multiple Data Coordinators and Data Managers. Required to support all areas of escalation related to respective projects.
Master's degree and at least 4 years of experience as a Data Manager, or Bachelor's degree and at least 5 years of experience as a Data Manager;
Strategize and participate in the further development of departmental processes and procedures;
Serve as a program data management lead on multiple complex clinical trials;
Lead and coordinate departmental initiatives related to improvements and integration of new technology;
Manage and supervise at least one Data Manager;
Communicate critical issues confronting projects and the action plans put in place to address those critical issues to senior management; and
Provide logical solutions to any escalated Data Management issues that arise during the course of any trial within the respective team.
■職種未経験者:不可