Senior Clinical Data Manager

Description

Senior Clinical Data Manager responsibilities include but are not limited to:

• Leads the data management team which may include data managers supporting the study and may be responsible for their oversight. Is the data management point of contact as the primary interface with an outsourced data management vendor or sponsor study data management team
• Ensures data management deliverables are met or exceeded within industry quality standards in a timely and cost efficient manner
• Incorporates and maintains company standards in clinical studies and projects for all elements of the medical standards package
• Documents all activities adequately for all assigned studies according to SOPs and cooperates with QA and ensures quality data management activities to include:
  •  Maintaining clinical trial documents pertaining to data management
  •  Coordinating and ensuring contributions from relevant functions (ie, EDC etc)
• Performs protocol conversion for the development of study specific eCRFs from the clinical study protocol and input from the study team, oversight of database build, develops data consistency checks, performs data review, query management, coding and SAE reconciliation between the clinical and safety databases
• Prepares, tracks and implements standard plans (Global Data Management Study Plan as applicable, to ensure proper governance of data management study set-up, conduct and closure activities
• Participates in QC and UAT of database design including data consistency checks and provides approval of design as a result of testing
• Accountable for data management activities necessary for the establishment of subject validity and analysis set assignment, including but not limited to the following: specification of protocol deviations, planning and conduct of interim and final data validity review meetings, preparation and completion of validity review report
• Supports data management and data cleaning processes
• Identifies and issue queries, incorporate query replies, track query status and apply permissible clarifications using the EDC and related systems as applicable

Qualifications:

• Bachelor's degree in Natural Sciences, Informatics, or Medical Documentation.
• Minimum 4 years of study level experience as a Data Manager in Pharmaceutical/Biotechnology industry in supportive and/or leading roles, EDC experience a plus

Skills:

• Strong written and oral communication skills in English
• Strong organizational skills and able to collaborate with minimal supervision
• Detail oriented, ability to multitask with strong prioritization
• Knowledge of clinical research operations in order to execute relevant data management activities independently
• Good understanding of the drug development process and ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology
• Proficiency in Microsoft Office Applications
• Strong familiarity with EDC and Clinical Data Management systems such as: TrialMaster, Rave, InForm, Clintrial or Oracle Clinical preferred
• Experience with data reporting tools: JReview, Spotfire, Business Objects or related preferred