Hi Professionals

Our company is looking for a *Clinical Data Manager (Our company IS CLIENT)*.
Qualified candidates should have experience working on *e-clinical software*
or *MERGE software*

*either fulltime or contract works*
*Location: Somerset NJ*

*JD:*

·         Performs ongoing Data Management activities such as data review
(based on programmed edit checks and or externally generated listings),
external vendor data processing, external vendor data reconciliation, SAE
reconciliation, medical coding.

·         Prepares and maintains clinical Data Management documents on
study level, including but not limited to Data Management Plans, eCRF
Completion Guidelines, Edit Check Specifications, and SAE Reconciliation
Plan.

·         Assumes Clinical Data Manager role for assigned studies to lead
and coordinates Data Management tasks including, but not limited to, data
review (based on programmed edit checks and or externally generated
listings), external vendor data processing, external Vendor data
reconciliation, SAE reconciliation, and medical coding.

   - Provides support for Data Management team.
   - Ensures project objectives meet quality acceptance criteria.

·         Coordinates with internal Information Technology team or EDC
vendor to perform activities such as eCRF development, database
development, and edit check programming.

·         Performs User Acceptance Testing (UAT) for all assigned studies
and ensures associated documentation is maintained.

·         Performs Quality Data Review on assigned studies.

·         May perform statistical programming in support of the
Biostatistics team as assigned.

   - May provide support for Information Technology and/or Quality
   Assurance teams and/or assume a lead role for assigned activities.
   - May collaborate with the Client on study design, protocol development,
   CRF design, Statistical Planning and CSRs.
   - May be responsible for establishing and maintaining study timelines
   and tracking timelines, management if resources.

·         May identify and manage team milestones and project risks.

·         Provides support for development of SOPs and guidance documents
related to departmental and organizational functions.

   - May provide input into cost proposals, client presentations.

·         Pro-actively identifies potential challenges and communicate that
fact with recommended solutions.




Best

Nicole

[email protected]

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