Clinical Data Manager
Well established international contract research organization serving both commercial as well as government markets, is conducting a search for a full time Direct Hire Clinical Data Manager to be based at the company's headquarters in Princeton NJ.
The successful candidate will possess a forward-thinking approach and be able to anticipate challenges and proactively implement solutions.
Responsibilities:
Act as lead data manager on multiple studies of moderate complexity with minimal supervision
Main point of client contact for all DM related matters
Execute all DM start-up activities, including the development and maintenance of
CRFs/eCRFs
Edit check and custom listing specifications
Data Management Plan
CRF Completion Guidelines
Conduct user acceptance testing of data outputs per DM specifications
Organize and actively participate in CRF review meetings with the client
Perform comprehensive hands-on data review of all patient data through query management and/or manual review
Analyzes study metrics to continually assess both data quality and study progress
Track and provide project status updates to project managers for monthly project team meetings
Coordinate with Quality Assurance team to resolve any QA data issues
May assist in the mentoring of less experienced employees
Manage and prioritize project deliverables per study timelines
Reconcile SAEs and work with drug safety
Ensure that data quality and integrity is maintained from study start through database lock
Work closely with CRA's to address any negative data trends/issues specifically ahead of site visits
Provide ad hoc trainings to site members as needed
May assist the senior data manager based on study demands
Requirements:
Bachelor's degree, preferably in a science related field
3
years clinical data management experience in the CRO and/or pharmaceutical industry
Prior EDC experience along with demonstrated experience starting up trials (designing CRFs/eCRFs, edit checks, CRF completion guidelines, DMP, etc.).
Knowledge of GCP and ICH guidelines
A team player with strong analytical skills who is highly organized and results-oriented.
Strong attention to detail along with exceptional communication skills.
Flexibility and agility to adapt to changing scope of workEstimated Salary: $20 to $28 per hour based on qualifications.
The successful candidate will possess a forward-thinking approach and be able to anticipate challenges and proactively implement solutions.
Responsibilities:
Act as lead data manager on multiple studies of moderate complexity with minimal supervision
Main point of client contact for all DM related matters
Execute all DM start-up activities, including the development and maintenance of
CRFs/eCRFs
Edit check and custom listing specifications
Data Management Plan
CRF Completion Guidelines
Conduct user acceptance testing of data outputs per DM specifications
Organize and actively participate in CRF review meetings with the client
Perform comprehensive hands-on data review of all patient data through query management and/or manual review
Analyzes study metrics to continually assess both data quality and study progress
Track and provide project status updates to project managers for monthly project team meetings
Coordinate with Quality Assurance team to resolve any QA data issues
May assist in the mentoring of less experienced employees
Manage and prioritize project deliverables per study timelines
Reconcile SAEs and work with drug safety
Ensure that data quality and integrity is maintained from study start through database lock
Work closely with CRA's to address any negative data trends/issues specifically ahead of site visits
Provide ad hoc trainings to site members as needed
May assist the senior data manager based on study demands
Requirements:
Bachelor's degree, preferably in a science related field
3
years clinical data management experience in the CRO and/or pharmaceutical industry
Prior EDC experience along with demonstrated experience starting up trials (designing CRFs/eCRFs, edit checks, CRF completion guidelines, DMP, etc.).
Knowledge of GCP and ICH guidelines
A team player with strong analytical skills who is highly organized and results-oriented.
Strong attention to detail along with exceptional communication skills.
Flexibility and agility to adapt to changing scope of workEstimated Salary: $20 to $28 per hour based on qualifications.
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