Manager, Data Management - Hybrid Or Remote

Company: Baim Institute for Clinical Research
Location: Tustin
Posted on: May 15, 2022

Job Description:

The Manager, Data Management represents Data Management (DM) on Baim project teams and will serve as the Baim DM contact with sponsors on data management issues/activities. The primary responsibilities include coordinating the receipt and processing of information for projects (e.G., coding dictionaries, trial specific information, and transfer database specifications) as well as electronic data received from specialty groups utilized on projects and coordinating the building, testing, validation, and maintenance of clinical databases. Responsibilities will also include mentoring a group of assigned DM and EDC Services staff and for contributing to the overall training and supervision of the departmentPrimary Duties and Responsibilities:Represents data management on project teams.Serves as the data management contact with sponsors.Assist Director in supervision and management of the activities of all levels of Data Managers.Represent the Data Management and EDC Services Department in capabilities presentations, sponsor demonstrations, bid defenses, and internal and external audits, as assigned.Work with Director to identify potential problems with data quality and suggest methods for improving processes and workflow on projects.Working with the Director to ensure direct reports meet and aim to exceed their personal goals and objectives by developing appropriate training programs for department personnelMentor and provide training for Data Management and EDC Service staff, as assignedDesigns case report forms, edit check specifications and other relevant database specifications for new trials as assigned.Coordinates the building and validation of Baim clinical databases as assigned.Develop and maintain the Data Management Plan, CRF Completion Guidelines, and other DM study documentation.Reviews clinical data, issues & resolves queries to clean the data for analysisCoordinates the receipt and processing of electronic data received from specialty groups utilized on projects (e.G. central lab, core lab).Responsible for the development of standard and custom status reports to meet the needs of the Baim Management, Baim project team and sponsor.Contribute to and follow streamlined processes.Responsible for the development of standard and custom status reports to meet the needs of the Baim Management, Baim project team and sponsor.Contribute to and follow streamlined processes.Program SAS listings or other system listings (Excel, EDC reports, etc.) to use for data cleaning, outlier identification and to look for data trends or issues.Perform SAE Reconciliation.Meet project budget and timelines.Recognizes data management project issues needing to be brought to the attention of management, sponsor, or other Baim functional departments (i.E. clinical, safety, biometrics, and regulatory).Is responsible for assisting in the training of Data Managers and other DM personnel on project related responsibilities for the trials they lead.Ensure readiness for transfer and/or statistical analyses at established time points.Organize and maintain documentation.QUALIFICATIONS:Required: BA/BS in a related field such as a Life Science, Computer Science, Biostatistics; Master's degree preferred5 7 years data management experience.Experience with EDC systems such as InForm, IBM Clinical Development (Formerly Merge eClinical OS), or iMedNetThorough knowledge of all data management processes from study start-up to study close-out.Strong ability to be able to switch between different tools for data cleaning (e.G. EDC to SAS EG)Knowledge of/experience in SAS EG or Base SAS preferredStrong understanding of clinical database management systemsAttention to all the following: detail, quality, timelines and customer focusStrong ability and willingness to work to deadlines independentlyStrong ability to handle multiple projects and changing prioritiesStrong interpersonal, communication and leadership skillsAbility to maintain positive relations with sponsor and vendor team membersStrong understanding and awareness of applicable government regulations (FDA, GCP, NIH, HIPAA)Understanding of ICH guidelines and regulations as they pertain to clinical database management, clinical data reporting and computer systemsCertified Clinical Data Manager a plus

Keywords: Baim Institute for Clinical Research, Tustin , Manager, Data Management - Hybrid Or Remote, Executive , Tustin, California