Clinical Data Reviewer - 6 Months - WFH - Pharma UK

Job Ref: J29905
Sector: Clinical
Sub-sector: Pharmaceuticals
Job Type: Temporary
Date Added: 04 March 2019
  • England, UK UK EC2M 4YD
  • £45 - £50 per Hour
  • Sabrina Andresen
  • 02030964701

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Clinical Data Reviewer - Oncology - 6 Months Global Pharma, Full TimeHomebased (UK ONLY)Start: ASAPRate: £45-50 pr. hr SRG are recruiting for a Clinical Data Reviewer for 6 months contract which can be fully homebased in the UK for a Global Pharma Company.The Clinical Data Reviewer (CDR) is a highly specialized role that performs clinical data review, typically ahead of significant project milestones (interim analysis, study closeout, submission etc.). The studies supported by the CDR are often, but not exclusively, complex comparative safety and efficacy (phase 3) trials with large, multi-faceted data sets. The review tasks performed by this role include both point-to-point clinical data checks and interpretive analysis This requires that the CDR be knowledgeable about the therapeutic area under investigation, expected effects of the investigational drug and concomitant medications, and possess sufficient clinical knowledge to assess if patient data is scientifically and clinically valid. About the Role:* Clinical data review of one or more studies with the ability to move easily from project to project as necessary. * Comprehensive knowledge and understanding of the therapeutic area under study and uses that knowledge to ensure that patient data are scientifically and clinically valid. * The studies supported by the CDR are often, but not exclusively, complex comparative safety and efficacy (phase 3) trials with large, multi-faceted data sets In addition the CDR ensures data readiness for important milestones including, but not limited to, interim analysis, final analysis, snapshots to support submissions, Data Monitoring Committee reviews and publications. * Review tasks include both point-to-point data checks (e.g., verifying the presence of a blood pressure value that satisfies study inclusion criteria) and interpretive analysis (e.g., evaluating subject to find inconsistencies the patient's data)* Create and use data review best practices and associated data review tools to identify trends and any safety signals.* Follows relevant SOPs and regulations, has an excellent understanding of and complies with applicable training requirements, constantly seeking further improvements in quality and efficiency of clinical procedures. Qualifications:* Bachelor's Degree in one of the disciplines related to life sciences, drug development or business. * Advanced degree is desirable.* At least 5-7 years of clinical experience in pharmaceutical industry.* Direct clinical data review experience - reviewing data from a clinical perspective, and writing queries.* A thorough understanding of the processes associated with reviewing and delivering quality data. * Strong field monitoring experience an asset * Deep Clinical Research experience in the phase 3/pivotal space, ideally on the side of the sponsor and with a track record of successful regulatory submissions * Strong background in Oncology * Strong technical data review skills and comfortable with the review of large sets of clinical data under often challenging timelines.* Familiar with Oracle Clinical Remote Data Capture and/or other database systems; technically competent with Microsoft Excel and ideally, Access.* Possesses at least basic knowledge of data management including case report form design, workings of electronic edit checks, implementation of data handling conventions and interpretation of data status reports.HOW TO APPLY?Click on the "apply" button below. Please contact Sabrina Andresen on +44 (0)203 096 4701 or if you would like to know more about this opportunity. The role will only remain opened for a few days so don't wait up.Our team at SRG Clinical also cover roles in Biometrics (Statistics, SAS programming Clinical Operations (CPM, CRA etc.),Data Management), Medical information, Medical affairs, Pharmacovigilance and Regulatory affairs so do not hesitate to call me at +44 (0)203 096 4701.About SRGAt SRG Clinical, we are Professional (we provide a professional service in a timely manner to add value to our candidates and clients), we are Specialists (covering nearly 70 years of Life Sciences Recruitment experience within our vertical markets ), we are Honest (we provide an honest and transparent service to both our clients and candidates: treating others as we would wish to be treated ourselves.) and we are Internationals (our team is made of UK and European nationals speaking 10 languages (English, Danish, French, Italian,

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.

03/04/2019 13:49:06
GBP 45 45