Senior Clinical Data Manager - Remote or Hybrid
Company: Baim Institute for Clinical Research
Location: Orlando
Posted on: May 16, 2022
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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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