Senior Clinical Trial Operations Team Assistant 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, Pharmaceuticals, Clinical ResearchIndustries

Requirements

BA/BS within life sciences or equivalent
At least 2+ years of relevant clinical trial or clinical research experience within CRO, biotech, pharma, or academic research facility
Study coordinator or CRA experience a plus
Strong knowledge of drug development SOPs, ICH/GCP requirements, clinical trials, medical terminology

Responsibilities

Work proactively and independently to prioritize, perform and/or coordinate assigned activities, collaborating with cross-functional team members and key stakeholders to support successful delivery within established parameters set by the study team and compliance with SOP and quality standards
Provide logistical/operational support for study(ies) and department meetings (scheduling/planning, agenda, distribution of minutes or equivalent, etc.)
Management and oversight of Study Team shared repositories and communication platforms
Initiate and coordinate the completion of key activities, i.e. study level documents, forms and data entry into various clinical systems
Tracking, oversight of key activities, completion of forms, data entry into applicable systems, and collating study level information from multiple sources e.g. functional lines, vendors, systems etc. for status updates such as monthly reports and tracking of performance metrics, etc
Support tracking and management of clinical trial data, clinical trial budget spend and vendor invoices
Assist with collection, review, QC and filing of essential documents, ensuring TMF completeness
Support Study Team and Quality Team with Inspection Readiness activities
Act as Subject Matter Expert or Technical Resource for key clinical trial processes, systems, and tasks
Support clinical operations with on-boarding for new hires, organization chart updates
Identify, recommend, and participate in special projects (workstreams, initiatives) for continuous improvements, best practice and operational efficiencies

Skills

ICH/GCP

SOPs

Clinical Trials

Vendor Management

Meeting Scheduling

Document Tracking

Data Collation

Study Team Support

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

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Paid Vacation

Parental Leave

401(k) Retirement Plan

401(k) Company Match

Commuter Benefits

Risks

Significant YTD price decline of -62.76% may affect investor confidence.

Key clinical trial data updates are not expected until 2025, causing uncertainty.

Increased competition from companies like Editas Medicine poses potential conflicts.

Differentiation

Vor Bio focuses on protecting healthy cells while targeting cancerous ones.

The company specializes in innovative treatments for blood cancers like AML.

Vor Bio's approach aligns with the rise of personalized medicine.

Upsides

Recent $55.6M funding supports clinical trials and extends cash runway to 2025.

FDA's acceptance of gene therapies may ease approval for Vor Bio's treatments.

Advancements in CRISPR technology enhance precision of Vor Bio's gene editing.

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