Job Description

Clinical Data Manager
Number: 21-13463
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Clinical Data Manager for our client in Cambridge, MA.
 
Eclaro’s client is among the world’s largest pharmaceutical companies, trusted by billions to provide superior, cutting-edge, and inexpensive medicine that improves health and well-being. If you’re up to the challenge, then take a chance at this rewarding opportunity!
 
Position Overview:
  • A self-directed clinical data scientist to support the data quality efforts.
  • Responsible for conducting data quality management for our research studies.
 
Responsibilities:
  • Working with research team to identify and define data quality issues, for case-report form (CRF) data and non-CRF data especially data from digital devices
  • Establish methods and utilize/build tools to detect such issues for existing and incoming data, with automation where applicable (programing), properly log detected instances
  • Working with data manager / project manager, to follow through the detected instances, such as rectifying or reconciling data from clinical sites or vendors, and preventative actions to avoid similar issues in the future
  • Work under general supervision while compliant with local and our programs standard operating procedures (SOPs)
  • Review clinical trial data (identifies anomalies by performing Aggregate and/or Subject Level Data Reviews)
  • Conduct trend analyses in support of data quality and integrity, perform data analytics by reviewing reports and visualizations, interpreting data, identifying potential issues of concern, and presenting, at internal meetings
  • Initiate and manage data queries to clarify data that requires further investigation with the study sites to ensure an accurate and comprehensive data review
  • Summarize, and as necessary, provide training on case level anomalies or database level trends that do not require medical or clinical / scientific expertise, but require data management queries to ensure data entry guideline compliance as well as completeness, clarity, and accuracy of overall datasets
  • Serve as a Subject Matter Expert (SME), as appropriate.
  • Identify continuous process improvement opportunities (continuously looks for opportunities to improve efficiency of tasks and quality of deliverables).
  • Potential opportunity to further support efforts to design data quality management process and evaluate technologies of interest
  • Organizational Relationships: Work closely with technical leads, data managers, data scientists, statisticians and project managers, and may need to liaison with colleagues in other functions and collaborators from study sites.
 
Qualifications:
  • MS, Clinical Science or Data Science disciplines (Preferred: Clinical research experience with clinical data responsibilities)
  • Proven programming skills in Python
  • Attention to fine details and being well organized
  • Strong interest in digital clinical measures with mobile/sensor-based technologies
  • Highly self-motivated, can work both independently and in a team setting
  • Needs a strong data science background and preferably experience in clinical research data especially large-volume digital device data.
 
Preferred Skills:
  • Excellent written and verbal communication and interpersonal skills
  • Working knowledge of GCP, ICH, 21CFR Part11 and other relevant regulatory guidelines and standards as they pertain to role.
 
If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
 
If interested, you may contact:
Chris Imbien
Chris.imbien@eclaro.com
8428729257
 
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
 
 

 

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