Back to Job Search
Expired
  • Location: United Kingdom
  • Salary: A highly competitive rate (based on experience)
  • Job Type:Contract

Posted almost 2 years ago

  • Sector: Clinical Operations
  • Contact: Jay Baylis
  • Contact Email: jay.baylis@nextphaserecruitment.com
  • Contact Phone: 01403 216216
  • Duration: 12 Months
  • Start Date: 2022-06-23
  • Job Ref: V-47390
Job Title: Vaccine Clinical Data Reviewer (CDR)
Job Type: 12 month Contract
Location: Remote working
Salary: A highly competitive rate (based on experience)
 
The company:
My client is a patient centric company who strives to positively transform millions of lives through ground-breaking discoveries. They do this through having a breakthrough culture which is built upon hard working and forward-thinking individuals, each with a goal of making a positive difference to people’s lives through the work that they do.
 
Role Summary:
The position currently available is for a Clinical Data Reviewer. The Clinical Data reviewer role is a specialised contractor position within Vaccine Clinical Research. The main review tasks that this role would perform include, both point to point clinical data checks and interpretive analysis, such as reviewing data for submissions, highlighting errors and raising queries from a clinical perspective.

Role Responsibilities:
  • Review clinical data of one or more studies with the ability to move easily between projects
  • Primarily, but not exclusively, support comparative safety and efficacy (phase 3) trials with large multi-faceted data sets
  • Ensures data readiness for important milestones, such as interim analysis and final analysis
  • Review participant level data across a study in adherence with the Data Review Plan and for coordinating with Lead Clinical Scientist for study level review
  • Interpret data and identify issues of simple/moderate complexity in the data
  • Review tasks include both point-to-point data checks (e.g., verifying the presence of a temperature that satisfies study inclusion criteria) and interpretive analysis (e.g., evaluating subject to find inconsistencies in the patient's data)
  • Review study protocol deviations and ensure they are correctly reported and captured in the database
  • Collaborate with laboratory personnel to ensure the sample collection process is implemented correctly in the study
  • Create and use data review best practices and associated data review tools to identify trends and any safety signals
  • Follow relevant Standard Operating Procedures and regulations
  • Constantly utilise training and seek further improvements in quality and efficiency of clinical procedures
 
Skills and Experience:
  • 3 years + of relevant Clinical background or Data Management experience
  • Possess sufficient clinical knowledge to assess if participant data is scientifically and clinically valid
  • Prior InForm EDC experience preferred
  • Proficient in reviewing large scale listings in Microsoft Excel format (filter, sort, data format (date)
  • Proficient in accessing internal data systems such as CITRIX platform (JReview) to obtain data review listings
  • Basic understanding of how data points from different field/Case Report Forms interact and how data collection impacts analysis
 
Applicants must be eligible to work in the UK. If you have any questions about the role or would like to recommend someone who would be suitable for this position, please feel free to send an email or a copy of the persons up to date CV to jay.baylis@nextphaserecruitment.com.