Senior Clinical Data Manager 9/3/2016

Confidential Company Princeton, NJ

Company
Confidential Company
Job Classification
Full Time
Company Ref #
28672990
AJE Ref #
576086836
Location
Princeton, NJ
Job Type
Regular

JOB DESCRIPTION

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Our client, a well established international contract research organization serving both commercial as well as government markets, is conducting a search for a full time Direct Hire Senior 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 work