Clinical Data Manager

Clinical Data Manager
  • $95,000 - $115,000 per Hour
  • Permanent
  • Danvers MA, US Danvers ESSEX US 01923
Job Ref: JO000109319
Sector: Clinical
Sub-sector: Biometrics
Date Added: 12 February 2021

Direct Hire - REMOTE - Sr. Clinical Data Manager

SRG is recruiting for a Senior Clinical Data Manager responsible for executing and overseeing Clinical Data Management (DM) operational activities, ensuring compliance with protocols, timelines, good clinical practice, and regulations (US & EU). This is a Direct Hire/ REMOTE opportunity with a fantastic team!

Principle Duties and Responsibilities:

  • Oversee and manage DM related activities (which may be outsourced to DM Vendors) as well as other external data sources from study start-up to study close-out and final database lock/transfer while ensuring that all study deliverables and milestones are met on time and within budget
  • Coordinate and participate in the development of the clinical data model and/or database design according to protocol requirements and study specifications
  • Review data acquisition conventions and data review guidelines / diagnostic specifications consistent with the clinical data model, and CRF (eCRF) completion/monitoring conventions
  • Develops and test data management system edit/data validation checks (diagnostics) and special listings/procedures used as tools for the data review and discrepancy management activities
  • Authors, reviews/revises DM related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization
  • Develops specification and collaborates with programming for programming and QC of manual listings, external data reconciliation, metrics and custom reports as needed throughout the study.
  • Regularly reviews and queries clinical trial data as indicated in the Data Review Guidelines, Data Validation Specifications and Data Management Plan
  • Review study data for completeness and clinical sense. Assess the overall quality of data and identify key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns, e.g., increased frequency of queries, protocol deviations, and early treatment discontinuations

Job Qualifications:

  • Bachelor’s degree in a relevant scientific discipline or equivalent; Medical and/or advanced degree preferred
  • Minimum of 7 years of data management experience in the medical device, pharmaceutical, biotech and/or CRO industries, with experience in managing data from First in Man through Post Marketing clinical trials.
  • Skills present in core data management activities (e.g., Data Management Plans, data edit specifications, understanding of database dictionaries/specs, electronic data transfers, efforts/process in data quality assurance, use of medical coding dictionaries). CCDM Certification a plus
  • Prior knowledge and experience with Medidata Suite products (RAVE EDC, TSDV, CTMS) required. Experience with various other clinical databases preferred (e.g., Oracle Inform) and key technologies (e.g., SAS, Scanning/Imaging, IVRS/IWRS, ePRO)
  • Proficient on evaluating, testing, and managing new data standards, technologies, and systems.
  • Knowledge of FDA and EU regulations, GCP, GCDMP and ICH guidelines required specifically as it relates to ensuring compliance with these regulations and guidelines for audit readiness
  • Proficient in MS Word, Excel, Outlook, and PowerPoint.
  • Knowledge of Business Objects, J Review, Spotfire preferred
  • SAS and R programming and proficiency in other statistical packages is a plus

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

13/03/2021 12:00:00
USD 95000.00 115000.00 Hour
Contact Consultant:
Melissa Rodrigues

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