Clinical Data Reviewer

Job Responsibilities

• The CDR may be responsible for the clinical data review of one or more studies with the ability to move easily from project to project as necessary.

• The CDR has 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 performed by the CDR 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).

• The CDR will 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.

Requirements

• Bachelor’s degree in one of the disciplines related to life sciences, drug development or business. Advanced degree is desirable.

• At least 7 years of clinical experience in pharmaceutical industry.

• 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.

• Prior InForm EDC experience a must or very quick learner for data platform technology systems

• Proficient in reviewing large scale listings in Microsoft Excel format (filter, sort, data format (date)

• Moderate level of tech savvy to learn new systems quickly and to be able to navigate independently in different systems

• Basic understanding of how data points from different field/CRFs interact and how data collection impacts analysis

• Strong attention to detail

• Ability to work independently and as part of team

• Ability to prioritize and adjust work priorities quickly as needed to meet deadlines (i.e., fluid, flexible work style)

• Access to internal CITRIX platform (JReview) will be required to obtain data review listings

• Review tracking required (Excel format)

PHYSICAL/MENTAL REQUIREMENTS

Able to work on the computer, communicate efficiently via phone and/or WebEx.

Mentally able to fulfill the responsibilities of the role.

Must have the relevant personality features supporting the responsibilities:

• In addition to the required technical knowledge and experience, a CDR must possess a willingness to perform primarily data review tasks.

• Able to work independently for periods of several days with minimal supervisory contact.

• Willing to work in a virtual team setting where there is very little in-person contact.

• Leverages knowledge from others related to overall objectives, strategy, critical issues and policy matters.

• Has foresight and judgment in complex decisions.

• Leverages a variety of communication tools and techniques to communicate results.

• Promotes innovation and takes appropriate risks to challenge the status quo, resulting in enhanced processes.

• Ability to work proactively and independently, organize tasks, time and priorities of self and others; ability to multi-task.

• Collaborative problem solving (handles conflict constructively).

• Able to embody leadership behaviors and competencies.

Salary

$80,000 – $123,533 a year

Benefits

• 401(k) matching
• Company car
• Dental insurance
• Employee stock purchase plan
• Health insurance
• Paid sick time
• Paid time off
• Vision insurance