Group Data Manager
This position is important to the overall operation of Promedica International. This position reports to the Director, Clinical Operations.
This position performs Data Manager duties directly as required and manages Data Managers, Medical Data Reviewers, Data Coordinators, Biostatisticians and SAS Programmers.
This position may involve up to 10% travel and requires a person who works effectively with clinicians, allied healthcare personnel, clients, vendors, and Promedica International staff by:
- Sharing ideas in a constructive and positive manner
- Listening to and objectively considering ideas and suggestions from others
- Keeping commitments
- Keeping others informed of work progress, timetables and issues
- Addressing problems/issues constructively to find mutually acceptable solutions
- Respecting the diversity of our work force in actions, words, and deeds
Duties of this position may be described in the following functions below. This description is representative, but not all-inclusive, based on the company’s growth.
Accountability/Responsibilities
Manager, Data Managers, Medical Data Reviewers, Data Coordinators, Biostatisticians and SAS Programmers
- Manages Data Managers, Medical Data Reviewers, Data Coordinators, Biostatisticians and SAS Programmers. Responsibility for input to data management staff procurement, training, quality of service and quality of deliverables and SOP adherence. Mentors data management staff to maximize each person’s professional goals and growth within the company. Administers annual reviews and provides ongoing performance input.
- Establishes and maintains department Standard Operating Procedures for data management activities. Works with Quality Systems Manager and/or Administrator to revise, develop, or implement new procedures as required.
Project and General Management/Administration
- Develop data management plans and other key study documents through collaboration with clinical Project Manager(s) and statistician(s).
- Interfaces with IT Manager, Project Manager, and Software Developer to review project database implementation schedules, database utilization training, and database utilization efficiency.
- Participates in the project clinical data system design, utilization, and maintenance to maintain conformance with FDA guidelines for clinical data management.
- Review protocols for CRF design and creation; develop electronic CRFs, edit checks, for use in clinical data management system.
- Collaborate with biostatisticians in the creation of analysis datasets.
- Perform database quality assurance audits and database locks.
- Create test data and perform user acceptance testing on new databases.
- Provides recommendations for improvement of project or departmental efficiencies based on work experience and observations.
- Participates in project review meetings as requested by Project Manager.
- Participates in business development activities including input to proposals and bid defense meetings as needed.
- Participates in budget maintenance for data management related activities.
Position Functions by Percentages:
Group Data Management 40%
Data Manager project assignments 60%
Experience/Skills Recommended for Position:
- Proficiency in Data Management Plan development and maintenance, CRF design, database development (DDS, validation, UAT).
- Thorough understanding of FDA regulations regarding management of data for clinical studies.
- Familiarity with current data standards (e.g., XML/CDISC) and database administration.
- Proficiency with EDC systems, Word, Excel, Access, PowerPoint, and Outlook, as well as web-based software systems. Understanding of SAS, Microsoft SQL.
- Knowledge of programming in SQL reporting using Microsoft SQL Reporting Services and Crystal Reports desirable.
- Strong communication skills as demonstrated via telephone interactions, personal presentations, and general written correspondence.
- Well-organized, with strong attention to detail, documentation, and follow-through. Ability to work on multiple tasks simultaneously.
- Leadership skills, and ability to work effectively within a team configuration.
- Minimum 5 years’ experience in data management.
- BS or BA degree.
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