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Senior Clinical Data Manager - Remote or Hybrid

Company: Baim Institute for Clinical Research
Location: Orlando
Posted on: May 16, 2022

Job Description:

The Senior Data Manager represents Data Management (DM) on Baim project teams and serves as the Baim DM contact with sponsors on data management issues/activities. The primary responsibilities include coordinating the building, testing, validation, and maintenance of clinical databases, reviewing the clinical data and oversight of DM project work. It also includes coordinating the receipt and processing of information for projects (e.g., coding dictionaries, format libraries, and transfer database specifications) as well as electronic data received from specialty groups utilized on projects. The Senior Data Manager's other responsibilities include auto encoding of AE's and concomitant medications, creation of study-specific Data Management Plans and project status reporting to Baim project team and sponsors. Additional responsibilities include mentoring and training other data managers as well as coordinating activities of the data management team members assigned to projects. May represent data management department in committee meetings

Primary Duties and Responsibilities:
Represents Data Management on project teams.
Coordinates the building and validation of Baim clinical databases
Reviews clinical data and sends and integrates queries to clean the data for analysis
Directs/coordinates the activities of other DM personnel, including other Data Managers, on assigned projects to ensure timely completion of high-quality projects
Serves as the Baim DM contact with sponsors. Establishes working relationships with sponsor's data management counterpart
Coordinates the receipt and processing of electronic data received from specialty groups utilized on projects (e.g. central lab, core lab.)
Coordinates the receipt and implementation of sponsor's coding dictionaries, format libraries, and database transfer specifications
Establishes/negotiates DM timelines and ensures DM project milestones are met
Is responsible for the development of standard and custom database status reports to meet the needs of the Baim project team and sponsor.
Recognizes data management project issues needing to be brought to the attention of sponsor or other Baim functional departments)
Directs/coordinates the activities of other DM personnel, including other Data Managers, on assigned projects to ensure timely completion of high-quality deliverables
Is responsible for assisting in the training of Data Managers and other DM personnel

Secondary Duties:
Interaction with vendors, including core labs
Support of Clinical Event Department in collecting data for event adjudication
Provide Data Requests per Sponsor requests
Represents data management department at investigator meetings
SOP and Work Instruction development and/or review
Understanding and Awareness of project budgets
Interviewing potential data management staff
Assist on projects on an as needed basis
Workflow review and process improvement
Technical support for departmental staff
Troubleshoots CRF's received that cannot be tracked or entered.
Knowledge of project budgets - provide feedback on budgeting process

Requirements
High School Diploma plus 9 years data management experience, or an Associate Degree with 6 years data management experience, or a Bachelor's Degree with 4 years data management experience.
Understanding and awareness of applicable government regulations (FDA, GCP, NIH, HIPPA).
Experience with EDC systems such as InForm, IBM Clinical Development (Formerly Merge eClinical OS), or iMedNet
Thorough knowledge of all data management processes from study start-up to study close-out.
Knowledge of/experience in SAS EG or Base SAS is desirable
Attention to all the following: detail, quality, timelines and customer focus
Strong ability to handle multiple projects and changing priorities

Keywords: Baim Institute for Clinical Research, Orlando , Senior Clinical Data Manager - Remote or Hybrid, Executive , Orlando, Florida

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