Senior Clinical Data Manager

At InterVenn, we believe no one should be blindsided by disease. Our technology enables and empowers the understanding of Glycoproteomics, a new clinical layer of biology beyond the genome, using a simple blood draw. InterVenn’s powerful solutions will broaden humankinds’ perception and interpretation of diseases like cancer. We look forward to having new members join our team who have diverse perspectives and backgrounds, challenge the status quo, and are solution oriented. If this is you, read-on and apply. Together, maybe we can change the world.

Responsibilities

• Provide clinical data management support for study operations and analysis groups with minimal guidance
• Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies and projects
• Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design; Be able to perform a thoroughly detailed review of eCRF data requirements and create one if need be
• Perform reconciliation of data from external data sources against the clinical database
• Assist in defining and creating data listings, including programming software to generate listings
• Generate data specifications and/or process data transfers in preparation for scientific and/or statistical review
• Perform data cleaning activities including processing queries, performing ongoing data review, and orchestrating scheduled cross-functional data review/reconciliation, identifying issues, data trends and tracking them through resolution
• Actively review and provide feedback on study data quality including providing data management metrics, review project statement of work and identify and report to manager any requested out of scope activities

Qualifications

• Bachelor's Degree required in a scientific/technical/healthcare field 
• At least 5 years' experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment, including study lead experience
• EDC system experience (preferably Medidata Rave)Excellent R or SAS programming skillsProficient with SQL and ability to manage data in an RDBMS (mySQL, Oracle, etc.)
• Must have good project management skills and a proven ability to multitask
• Comprehensive understanding of regulatory guidelines and industry standards (ICH/FDA guidances, CDISC standards, 21 CFR 11, CTCAE, MedDRA, WHO Drug Dictionaries, etc.)

Ensuring a diverse and inclusive workplace where we learn from each other is core to InterVenn’s values. We welcome people of different backgrounds, experiences, abilities and perspectives. We are an equal opportunity employer and a fun place to work. Come do the best work of your life here at InterVenn.