Magnit Global is a leading, global professional services and technology company and a certified "Great Place to Work". We have been a leader in contingent workforce management since 1991 and work with leading Fortune 500 companies and other large organizations across numerous verticals including consumer electronics, research and development, pharmaceuticals, health services, and many more!
We're glad to continue a relationship with you and happy to assist in the next steps of your career once more!
This contract opportunity is with Insmed.
About the Role
Support clinical data management activities, including data analysis, database design, and quality control audits, to ensure compliance with standard operating procedures and enhance productivity.
What You'll Do
- Prepare data analysis listings and activity, performance, or progress reports.
- Process clinical data including receipt, entry, verification, or filing of information.
- Prepare appropriate formatting to datasets as requested.
- Design and validate clinical databases including designing or testing logic checks.
- Design forms for receiving, processing, or tracking data.
- Develop or select specific software programs for various research scenarios.
- Analyze clinical data using appropriate statistical tools.
- Write work instruction manuals, data capture guidelines, or standard operating procedures.
- Track the flow of work forms including in-house data flow or electronic forms transfer.
- Train staff on technical procedures or software program usage.
- Supervise the work of data management project staff.
- Read technical literature and participate in continuing education or professional associations to maintain awareness of current database technology and best practices.
- Provide support and information to functional areas such as marketing, clinical monitoring, and medical affairs.
- Evaluate processes and technologies, and suggest revisions to increase productivity and efficiency.
- Develop technical specifications for data management programming and communicate needs to information technology staff.
- Contribute to the compilation, organization, and production of protocols, clinical study reports, regulatory submissions, or other controlled documentation.
- Perform quality control audits to ensure accuracy, completeness, or proper usage of clinical systems and data.
- Monitor work productivity or quality to ensure compliance with standard operating procedures.
- Generate data queries based on validation checks or errors and omissions identified during data entry to resolve identified problems.
- Confer with end users to define or implement clinical system requirements such as data release formats, delivery schedules, and testing protocols.
- Develop project-specific data management plans that address areas such as data coding, reporting, or transfer, database locks, and workflow processes.
- Facilitate updating DM Documents (Data Management Plan, Data Validation Plan, Data Review Plan, CRF Completion Guidelines) per Lead DM expectations.
- Verify external vendor test data per specifications document.
- Run and review outputs and database study metrics.
- Participate in data reviews.
- Review discrepancies in EDC system, monitor/facilitate resolution and closeout or re-query per study guidelines; note and communicate trends to clinical trial manager(s) for follow-up.
- Reconcile external data to clinical study database and perform Serious Adverse Event reconciliation.
- Ensure DM procedures and processes are adhered to in a consistent manner.
What You'll Bring
- Hands-on experience with Electronic Data Capture systems (Medidata Rave desired).
- Excellent communication skills (verbal and written).
- Experience working in a cross-functional team environment.
- Strong organizational skills.
Minimum Qualifications
- Associates Degree or higher is required.
Preferred Qualifications
- Minimally 2 years of clinical data management experience in a biotech, pharmaceutical, or CRO environment is preferred.
This is the pay range that Magnit reasonably expects to pay for this position: $58.92/hour - $58.92/hour.
Benefits: Medical, Dental, Vision, 401K