Senior Clinical Data Manager - Remote or Hybrid
Company: Baim Institute for Clinical Research
Location: Seattle
Posted on: June 25, 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 meetingsPrimary 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, Seattle , Senior Clinical Data Manager - Remote or Hybrid, Executive , Seattle, Washington
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