Data Reviewer Job Description
Data Reviewer Duties & Responsibilities
To write an effective data reviewer job description, begin by listing detailed duties, responsibilities and expectations. We have included data reviewer job description templates that you can modify and use.
Sample responsibilities for this position include:
Data Reviewer Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Data Reviewer
List any licenses or certifications required by the position: CDRO, ODR
Education for Data Reviewer
Typically a job would require a certain level of education.
Employers hiring for the data reviewer job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and University Degree in Chemistry, Biochemistry, Science, Pharmacy, Biology, Life Sciences, Associates, Education, Microbiology, Nursing
Skills for Data Reviewer
Desired skills for data reviewer include:
Desired experience for data reviewer includes:
Data Reviewer Examples
Data Reviewer Job Description
- Reviews and in some instances performs routine data backups of data systems
- Periodically audits system audit trails against paper records, usage logs
- Reviews system policies and user access controls against paper records
- Assist in perform Quality Assurance audits of laboratory and manufacturing areas to ensure cGMP compliance
- Assist in the investigation and review of deviation reports and reports to assure complete compliant source data
- Assist in training and mentoring a variety of personnel on the use of electronic data systems
- Maintain a professional demeanor and adapt well in high stress environments
- Responsible for verifying all laboratory testing was conducted in accordance with SOPs cGMPs and GLPs
- Review of laboratory notebooks and other source data
- Understands how data related issues can impact analysis and reporting and applies the escalation path appropriately
- Bachelor’s degree (BS) in the Life Sciences (e.g., Chemistry, Biochemistry, or closely related field), Pharmacy or Information Technology or Data Systems from an accredited four-year college or university
- 2 or more years of demonstrated excellence in a quality field within regulated industry, pharmaceutical manufacturing preferred
- Ability to work in an independent manner, group environment
- Ability to maintain confidentiality of certain information
- Evaluate on an ongoing basis relevant reports with regard to performance of the data collection, cleaning and review process and interact with Study Data Manager/Project Data Manager to take appropriate action within Data Review & Operations, Clinical Data Management, external partners and other roles within the Global Clinical Team or Study Team
- Review relevant quality parameters
Data Reviewer Job Description
- Effectively uses available tools and systems to gather information needed to manage clinical data listing review, generates reports and provides feedback to the appropriate BMS team members
- Serves as key point of contact to protocol team to address issues related to data quality at worldwide level
- Provides Protocol and/or Program specific data cleaning and review guidance to the team
- Accountable for facilitating the tracking, and monitoring the progress, of data review activities with protocol CDR team
- Collaborates with other Lead CDRs to establish best practices to ensure consistency across program and/or indication in data cleaning requirements
- Effectively drives or contributes to non-project taskforces, business work streams, and initiatives
- Empowers team to achieve high performance and excellence
- Abstract essential health care information, such as allergies, medications, diagnosis, from patient’s paper chart for entry into Electronic Medical Records (EMR)
- Determine accurate ICD-9 or CPT codes for current diagnoses and personal family history
- Identify and research needed information to ensure accuracy and completeness of medical record
- Ensure appropriate oversight process and measures are available to Global Clinical Teams and Study Teams in internal and outsourced studies that allow to manage risks associated with the completeness and correctness of the clinical database, patient safety, data quality or performance issues in a timely manner
- Pro-actively address quality or performance issues with the respective PDM/SDM and on a (cross-) functional level and contribute to the definition of additional measures for (re-)training, edit checks, sourcing
- Monitor overall performance of ongoing data cleaning across the functional roles involved
- Apply and contribute to the development of adequate Data Management Best Practices within scope of own responsibilities and task assignments across Therapeutic Areas
- Manage multiple studies at the same time while balancing the priority in alignment with teams and Head Data Review and Operations
- Bachelor’s degree (or equivalent) in Natural Sciences, Informatics, Statistics or Medical Documentation
Data Reviewer Job Description
- Review data according to Client guidelines
- Review current technical and clinical data available for the company products to determine if the data could be used to demonstrate compliance to the proposed new IVD product regulations
- Work closely with the Project Lead to ensure key elements of the IVDR project plan are delivered
- Position will have an element of working independently but will also need to collaborate with Clinical Affairs, Technical Support, Medical Affairs and R&D in order to meet project goals
- Based on the classification assessment of the products, undertake an assessment of a sample of different classes of product against the Technical Documentation and identify any gaps and in particular, significant gaps
- From the representative product sample, identify the time and resources required to address any gaps that can be used for budget planning purposes, particularly if product testing or performance evaluations are required
- Create draft Performance Evaluation Reports for a representative sample of Blass B, C and D products
- Propose opportunities for filling any identified gaps with data from other sources such as published literature, post-market data
- Provide periodic updates to the Project Lead at a frequency to be determined
- Review and Approve or deny connections within a review tool based on Facebook Policy
- Good business understanding of clinical development processes
- Basic understanding of and experience with descriptive data analysis methods
- Experience in using data management technologies
- Ability to work in changing environment and to work both independently and collaboratively
- Flexibility to work on different studies/projects, reporting to different PDMs/SDMs within data management teams
- Effective interpersonal and communication skills in a global virtual environment
Data Reviewer Job Description
- Review subjective content
- Correspond with internal Facebook salespeople regarding any appeals filed
- Provide QA support for a variety of projects at the site. These projects can include putting procedures in place for new manufacturing areas, revisions to procedures for updated areas, assisting in implementation of new systems within the quality and regulatory arena
- Responsible for ensuring the integrity of all data and documentation reported from the
- This individual will work independently with guidance in only the most complex situations and serve as a close partner to the physician and clinical scientist on the team
- This position will have key relationships internally with clinical project teams, operations and data management, with other members of the data review team
- Review and interpret medical data and clinical trial data, submit queries to data management and sign off on responses from sites
- Will be responsible for all key components of data review including but not limited to eligibility, adverse events, dosing and study termination
- Ensure own work, and work of team, is compliant with Safety, Health and Environment standards and all other relevant internal and external regulations so that study is audit ready
- Provide back-end support to our client's customer
- 1-2 years of QA/QC experience is required thorough knowledge of Federal regulations and SOP's
- Knowledge of immunochemistry, bioanalytical testing, divisional SOPs and FDA regulations
- Ability to evaluate lab data, review data for accuracy and detail, recommend changes and corrections as needed
- One year of QC experience
- Previous experience with data analysis, QC or quality testing also a plus
- Must be detail oriented and able to deal with multiple and changing priorities
Data Reviewer Job Description
- Need to keep up to date with events & happenings in countries of the supported language
- Participate in generating improvement ideas
- Report reviewer to proofread and check the quality of reports and numerical tables sent to clients
- Review and proofread data forms, data tables and reports
- Perform side-by-side comparison of both handwritten and digital material to ensure accuracy
- Ensure calculations are correct
- Identify where information is missing
- Flag inconsistences
- Review laboratory data and records to ensure conformance to Medtronic SOPs and cGMP/GDP requirements
- Collaborate with laboratory and quality personnel to meet Medtronic due dates
- Proficient with MS Word, Excel and Assist preferred, ability to update tables, proofread and update documents
- Fluent reading and writing skills in Turkish or Arabic
- Experience working in a team environment, preferably within a matrix organization
- Experience in effective implementation of data review/management plans/documents preferred
- Basic knowledge of data review process and awareness of associated systems and tools
- Basic understanding of project planning/management