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Clinical Data Management/ Clinical Data Reviewer

Bangalore, Karnataka

Synowledge PV Services India Pvt Ltd 

Job Description

Conducting manual data review for data management customers at the direction of the Clinical Data Lead or designee
Reviewing data and generating queries for each assigned study using standard query wording under the guidance of Clinical Data Lead or designee
Issuing queries based on manual data review requirements for each assigned study using standard query wording under the guidance of Clinical Data Lead or designee
Participating in internal project team meetings as necessary
Assisting in generating metrics and reports for current state of study database under the guidance of Clinical Data Lead or designee
Assisting in the management of the database cleaning and locking process
Performing test data entry for user acceptance testing as needed under the guidance of Senior staff/ Clinical Data Lead or designee
Performing Clinical Data Management user acceptance testing as needed/directed by the Clinical Data Manager
Performing production data entry as required
Assisting in performing third party vendor data and SAE reconciliations
Performing query management independently
Generating metrics and reports for current state of study database
Assisting in the management of the database cleaning and locking process
Performing external data reconciliation at the direction of the Clinical Data Lead
Performing Clinical Data Management quality review procedures based on Quality Management Plan

Maintains quality service and departmental standards by
Adhering to Clinical Data Management processes and standards by using implemented systems
Reading, understanding and adhering to organizational Standard Operating Procedures (SOPs)

SECONDARY RESPONSIBILITIES
Contributes to team effort by
Working with internal staff to resolve issues
Exploring new opportunities to add value to organization and departmental processes
Helping others to achieve results
Performing other duties as assigned

Maintains technical and industry knowledge by
Attending and participating in applicable company-sponsored training
Suggest process improvements

Company Description

Founded in 2006, Synowledge specializes in providing drug safety, regulatory affairs and... related IT services to small, mid, and large sized pharmaceutical, biotechnology and medical device companies. We are headquartered in Stamford CT, USA with operational facilities across the United Kingdom, Columbus, Ohio, and Bangalore, India. Our comprehensive outsourcing solutions combine the unique strengths of both onshore and offshore services to meet all of our clients’ pressing needs.
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Additional Information

Last updated:
22/04/2019
Job type:
Full time
Position type:
Permanent
Vacancies:
1
Minimum experience:
One year
Education:
Compulsory Education
Category:
Jobs in Healthcare / Medical / Pharmacy
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