Data Manager at Vor Bio

Boston, Massachusetts, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Bachelor's Degree in programming, health-related sciences, or relevant field
5+ years of Data Management experience

Responsibilities

Ensure the CRO and other internal and external partners align and conform to data management expectations for the assigned compound and/or indication
Participate in the creation of the clinical development plan, describing the clinical development strategy and possible innovative trial designs
Set quality expectations and timelines for data management deliverables and regularly follow up on data management milestones. Ensure inspection readiness at all times
Set expectations and communicate in a transparent, clear way and motivate team members to work towards achieving the clinical goals
Follow department and company standard operating procedures (SOPs), forms, templates and policies. Provide feedback and update these guidelines as needed
Develop, review, and maintain all study Data Management documentation
Coordinate with Database Developers to ensure effective database build and timely go-live to meet the needs of the project
Ensure the clinical database adheres to Clinical Data Acquisition Standards Harmonization guidelines allowing for optimal SDTM dataset programming. Suggest design for standard and non-standard data collection, identify any gaps in data collection, and challenge collection of unnecessary data
Define electronic case report form (eCRF) and edit check specifications to support data collection and analysis required per protocol
Take responsibility for and guide effective quality control (QC) review and user acceptance testing (UAT) of the clinical database prior to its release into production, including oversight of staff performing these tasks
Ensure data are properly reviewed in accordance with the Data Management Plan (DMP) and guidelines and that cleaning is effective and timely
Provide input on study timelines, identify risks, and communicate mitigation strategies to the Project Manager
Provide input into improving the efficiency of data management tasks
Lead and participate in intradepartmental or interdepartmental process and quality improvement initiatives

Skills

Clinical Data Management

Database Lock

Data Archiving

CRO Oversight

Data Quality Assurance

Regulatory Compliance

Mentoring

Clinical Development Planning

Vor Bio

Develops targeted therapies for blood cancers

About Vor Bio

Vor Biopharma focuses on developing treatments for blood cancers, particularly Acute Myeloid Leukemia (AML). Their approach is designed to protect healthy cells while specifically targeting and eliminating cancerous cells. This method aims to improve the effectiveness of blood cancer treatments. Vor Biopharma serves patients with blood cancers, their caregivers, and medical professionals in hospitals and oncology centers. What sets Vor Biopharma apart from competitors is their strong emphasis on research and development, investing significantly in scientific research to create a proprietary platform and pipeline of therapies. They generate revenue through partnerships with other pharmaceutical companies and licensing agreements, with the goal of commercializing their therapies after obtaining regulatory approval. The company's mission is to transform the treatment landscape for blood cancers by providing innovative therapies that prioritize patient safety and efficacy.

Cambridge, MassachusettsHeadquarters

2015Year Founded

$147.9MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

51-200Employees