Sr. Manager, Clinical Data Management

Overview

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Triveni Bio is breaking new ground in the identification of novel disease targets – working at the convergence of human genetics, best-in-class antibody design, and precision medicine. We are pioneering a Mendelian genetics-informed precision medicine approach to develop functional antibodies for the treatment of immunological and inflammatory (I&I) disorders. Our lead antibody program (TRIV-509) targets kallikreins 5 and 7 (KLK5 / 7) to directly impact skin barrier function, inflammation, and itch – providing a meaningful and much needed potential treatment option for patients with atopic dermatitis and other barrier disorders. In all the work we do, we adhere to our core values : patient impact, bold and rigorous science, open collaboration, kindness & respect.

SUMMARY

Triveni Bio is seeking a motivated and independent Sr. Manager, Clinical Data Management. In this role, you will be responsible for all data management (DM) activities across multiple studies at Triveni including CRF design, database development, and data quality assurance etc. You will serve as the primary contact for data management. On a day-to-day basis, you will take part in reviewing data, leveraging systems, vendor management and working with our Executive Director, Biostatistics to develop streamlined processes to best support the team. This is an exciting opportunity to join a growing Clinical Development team.

Responsibilities

• Act as the lead data manager across one or more clinical studies.
• Provide expertise and oversight of all clinical database activities from design / start-up to closeout.
• Review protocols for appropriate data capture including electronic (eCRF) design.
• Support CRF design, review, and validation of clinical database.
• Provide oversight of database set-up / migrations / upgrades including coordinating and / or performing User Acceptance Testing.
• Conduct oversight of data management vendors via ongoing review of quality and performance metrics.
• Generate, resolve, and track data queries to ensure the integrity of the clinical data.
• Facilitate and participate in data cleaning activities.
• Generate and / or review / approve study documents.
• Responsible for maintaining internal data management timelines and metrics. Maintain study DM related documents / files for inspection readiness.
• Proactively identifies potential data management issues / risks and communicates it within the study team for further action.

Qualifications

Triveni Bio, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Official Triveni Bio applications will always be submitted through Lever, our ATS. Any applications that take you to other platforms could be fraudulent. We do not use text or chat applications to conduct interviews or make job offers. Official Triveni Bio correspondence will always be conducted from email addresses ending in @triveni.bio. Please disregard any other communication that does not originate from this domain name. If you receive any suspicious requests or communications, please verify their authenticity before responding.

Location

Watertown, MA

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