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Company

Original Job Post

The Henry M. Jackson Foundation for the Advancement of Military Medicine · 2 days ago

Data Manager II

Bethesda, MD

Full-time

Remote

Mid Level

$55K/yr - $75K/yr

3+ years exp

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Responsibilities

Interact with Clinical Research Managers and Principal Investigators to assess study needs and plan study activities.

Lead a multi-functional team of data-related resources including data system programmers, and SAS and Oracle programmers.

Work with project management staff to define timelines of assigned studies to ensure study milestones are met.

Represents Data Management (and the DCC generally) during study team meetings, regularly informing project management of overall study data status and potential issues for resolution.

Work with project management and DCC study team to determine data to be collected and to develop data collection instruments, including annotated documentation.

Develop and maintain study-specific Data Management Plans.

Develop and maintain study-specific Data Quality Management and Validation Plans.

Develop other study-specific documentation manuals including data entry instructions and guidelines, coding manuals and Standard Operating Procedures, as needed.

Perform EDC data collection instrument User Acceptance Testing.

Record the receipt, track, and distribute research documents through the data management and verification process in a timely and accurate fashion.

Maintain files for storage of research documents.

Generate and distribute reports as necessary. This includes batch reports run on daily, weekly, and monthly cycles, status reports as well as any special purpose ad hoc reports.

Manage query submission, tracking and resolution for single complex studies or group of studies

Ensure research data are maintained at the highest level of quality, working with all appropriate staff to discover and address quality issues.

Review study databases for incomplete/missing data and other data issues.

Oversee the activities of other DCC staff assigned to manage studies.

Reconcile discrepancies and obtains guidance when values are questionable or illegible.

Interact with clinical personnel to resolve omissions, discrepancies, or any other data management issues.

Mentor junior Data Managers on standards, DM practices and Quality Assurance practices.

Generate, distribute, track, enter resolution, annotate, and file data entry reconciliation reports and data clarifications within the study folders.

Verify computer-generated output against original data.

Check work for accuracy on a daily basis according to established procedures.

Report any system/data errors and/or problems to their supervisor.

Assist clinical users in database interaction as necessary, performing queries upon supervisor’s direction.

Adhere to a policy of strict confidentiality concerning all documents, data, and information maintained within the department.

Adhere to department Standard Operating Procedures for all data management responsibilities.

Perform other duties as required.

Qualification

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Data ManagementClinical ResearchCRF DesignQA PlansData Status Tracking Data Management Practices Clinical PracticesFDA RegulationsICH RegulationsClinical Data Management SystemsREDCapOpenClinicaMedidata RaveOracle InFormOracle ClinicalDB VisualizerBasic SAST1/Public Trust Background CheckProblem-SolvingHard WorkingInterpersonal SkillsAdaptabilityTime ManagementCommunication SkillsTeamwork

Required

Bachelor's Degree

Minimum of 3-5 years Data Management experience in a clinical research environment, with at least 2 years’ experience as a Data Manager

Proficiency in the understanding, development, and execution in all aspects of clinical trial Data Management (e.g., CRF design, data entry instructions, data management and QA plans, resource planning, data status tracking, etc.)

Ability to manage multiple studies of medium complexity or size concurrently

In-depth knowledge of Good Data Management Practices, as defined by the Society for Clinical Data Management

In-depth knowledge of Good Clinical Practices, FDA, and ICH related regulatory requirements and terminology for clinical studies performed within the IDCRP

Experience using at least one clinical data management system (e.g., REDCap, OpenClinica, Medidata Rave, Oracle InForm, Oracle Clinical)

Ability to work independently, as part of a team setting, and meet deadlines

Excellent verbal and written communication skills, good organizational, interpersonal skills, and demonstrated ability to take the lead on projects

Ability to learn new systems when necessary for job completion (ex: DB Visualizer, and Basic SAS)

Customer-oriented outlook

Must be detail oriented; possess problem-solving skills, and the ability to handle multiple tasks and set priorities appropriately

Adaptable to changes in work duties, responsibilities, and requirements

Ability to obtain and maintain a T1/Public Trust background check