Sr. Manager, Clinical Data Management en Trivenibio
Trivenibio · Watertown, Estados Unidos De América · Onsite
- Senior
- Oficina en Watertown
COMPANY INTRODUCTION
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.
· Reviews protocols for appropriate data capture including electronic (eCRF) design.
· Support CRF design, review, and validation of clinical database.
· Provides oversight of database set-up/migrations/upgrades including coordinating and/or performing User Acceptance Testing.
· Conducts oversight of data management vendors via ongoing review of quality and performance metrics.
· Generates, resolves, and tracks data queries to ensure the integrity of the clinical data.
· Facilitates and participates in data cleaning activities.
· Generates and/or reviews/approves study documents.
· Responsible for maintaining internal data management timelines and metrics. Maintains 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.
EXPERIENCE AND QUALIFICATIONS
· Minimum BA/BS in scientific or health-related field.
· Minimum of 5+ years of clinical data management experience in the pharmaceutical, biotechnology industry or in a CRO.
· Possesses a comprehensive understanding of regulatory guidelines and industry standards.
· Familiarity with various data visualization, analytics, and reporting tools is a plus.
· Proficiency in electronic data capture (EDC) systems and clinical data management software. Veeva Preferred.
· Proficiency in Excel and/or R is preferred
· Understanding of data privacy and protection regulations (e.g., GDPR).
SUMMARYTriveni 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. · Reviews protocols for appropriate data capture including electronic (eCRF) design.· Support CRF design, review, and validation of clinical database. · Provides oversight of database set-up/migrations/upgrades including coordinating and/or performing User Acceptance Testing. · Conducts oversight of data management vendors via ongoing review of quality and performance metrics. · Generates, resolves, and tracks data queries to ensure the integrity of the clinical data.· Facilitates and participates in data cleaning activities. · Generates and/or reviews/approves study documents.· Responsible for maintaining internal data management timelines and metrics. Maintains 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. EXPERIENCE AND QUALIFICATIONS· Minimum BA/BS in scientific or health-related field. · Minimum of 5+ years of clinical data management experience in the pharmaceutical, biotechnology industry or in a CRO.· Possesses a comprehensive understanding of regulatory guidelines and industry standards.· Familiarity with various data visualization, analytics, and reporting tools is a plus.· Proficiency in electronic data capture (EDC) systems and clinical data management software. Veeva Preferred. · Proficiency in Excel and/or R is preferred· Understanding of data privacy and protection regulations (e.g., GDPR).
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.
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