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DATA MANAGEMENT POSTINGS

 

Job Title:	Clinical Data Manager
Category:	Exempt
Posting Code:	3027801
Location:	Fort Lauderdale, FL
Relocation:	No Relocation Assistant Available
Job Type:	Full Time Permanent
Shift:	1st
Purpose:	Manages Data Management staff to efficiently produce databases that meet Client's clinical study needs.
Summary of Major Responsibilities:	Manage a team of Data Management staff. Define and prioritize resource requirements and manage resource assignments across projects. Directly responsible for utilization of staff. Assess and document competency of staff to satisfy position resposibilities. Regularly set goals, evaluates, and documents performance. Propose salaries, promotion, and termination actions. Implementation of department objectives. Provide expert review and guidance for production of Data Management deliverables including CRF/e-CRF, database design and set-up, validation definition and programming, and Data Management Plan. Provide technical advice and solutions to solve problems and improve efficiency. Participate in the development and implementation of new processes and technology. Ensure that staff is trained and compliant with current operating procedures and work instructions and project scope of work. Identify and address professional development/training needs of staff. Mentor staff members to develop Data Management process, system, and drug development expertise. Ensure project milestones are met according to agreed upon timelines. Actively manage quality throughout project.
Summary of Major Requirements:	Bachelors degree in Computer Science/Information Technology or related field with a minimum of 7-10 years of relevant work experience. Advanced knowledge of Data Management process and systems. Technical programming may be required. Familiar with Oracle/Clinical and/or Integic. Oustanding written and oral communication skills are required. Solid understanding of clinical drug development process. Proven leadership skills. Previous people management experience is preferred. Excellent organizational skills and demonstrated ability to manage projects. Experience in effectively managing multiple tasks simultaneously. Effective problem solving skills.

         

Job Title:	Clinical Data Coordinator II
Category:	Non-Exempt
Posting Code:	3027812
Location:	Fort Lauderdale, FL
Relocation:	No Relocation Assistant Available
Job Type:	Permanent Full Time
Shift:	1st
Purpose:	The Clinical Data Coordinator II has responsibility of ensuring the validity of clinical trial data and formatting data for medical review and statistical analysis. Work is completed under supervision of the Clinical Data Manager or a team leader in Clinical Data. Accomplishments contribute to the completion of clinical studies.
Summary of Major Responsibilities:	The position is responsible for ensuring the validity of clinical trial data and to format and organize them for medical review and statistical analysis. Assists the Clinical Data Manager in implementing study specific procedures compliant with Regulatory and internal procedures and requirements by following departmental processes, study specific data management plans and study specific protocols. Execute data management plans that set out the process for entering, processing and validating the data. Execute data management plans for the implementation and management of medical data collection, review, clarification and reporting systems for clinical studies. Participates in database design and edit check validation. Manages the flow of data to and from the investigative sites for clinical studies across the Medtronic Vascular organization. Creates database design and edit check specifications through spreadsheets and determine data field name and properties. Validates database design in a test environment to test all aspects of the database design. Validate edit checks. Ensures that the Case Report Forms (CRFs) are transmitted to data entry staff and monitors timely data entry. Reviews and analyzes data listings for data discrepancies. Reviews automated validation system output and determines appropriate course of action to resolve data discrepancies according to established Standard Operating Procedures (SOPs). Reviews data discrepancy resolutions provided by the investigative sites and enter corrections in the database, as appropriate. Performs quality control checks on data to ensure data quality and accuracy.
Summary of Major Requirements:	Bachelor’s degree, preferably in a scientific field. A minimum of 2-3 years of experience in Clinical Data Management in the Pharmaceutical, Biotechnology or CRO industry. Familiarity with major data management functions and the requirements of Good Clinical Practice. A minimum of 2-3 years experience with a Clinical Data Management System, preferably Oracle Clinical. Knowledge of database architecture and structure is helpful. Knowledge of and experience with data processing, quality control and audit procedures. Some programming experience (PL-SQL or SAS) is preferred but not required. Demonstrated strong project management skills. Excellent organizational, verbal and interpersonal skills. Ability to work in a fast-paced office environment handling multiple demands and shifting priorities.

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