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Invivyd · 2 weeks ago

Senior Manager/Associate Director, Clinical Operations

New Haven, CT

Full-time

Hybrid

Senior Level, Lead/Staff, Director/Executive

5+ years exp

Invivyd is a company dedicated to delivering protection from serious viral infectious diseases, including COVID-19. The Senior Manager/Associate Director of Clinical Operations will oversee clinical trial management activities, ensuring successful execution of studies from protocol concept through to the clinical study report while managing external partnerships and mentoring staff.

BiotechnologyPharmaceuticalTherapeutics

Responsibilities

Oversee study management activities for local and global monoclonal antibody clinical research studies (Phase 1-4)

Responsible for clinical trial management activities on specified study in addition to local and global CRO oversight

Lead selection and management/oversight of external vendors; develop standard vendor specifications; review vendor reports, budgets and forecasts, and metrics

Review and negotiate contracts

Forecast costs for clinical studies

Review and approve invoices against approved budget/contract

Monitor subject accrual and study progress via standard reports

Oversee clinical monitoring from site qualification to site closure visits and ensure integrity of clinical data with respect to accuracy, accountability, and documentation through review of monitoring reports and completed case report forms

Update program team and Clinical Operations management on timelines and progress toward milestones

Apply Invivyd and industry standards across research program(s)

Provide guidance to Clinical Operations Leads in oversight of vendors and investigators to ensure compliance with the study protocol and overall clinical objectives

Collaborate with study leads to establish performance and quality metrics for the study and report metrics and that drive quality and efficiency

Work with Clinical Operations/Development management to support timely and in-budget completion of department goals by ensuring compliance and continuity with relevant SOPs and organizational work instructions

Support departmental initiatives aimed at innovation, process improvement, and efficiency

Develop or contribute to key vendor oversight plans and processes

Assist with the development of standard operating procedures (SOPs), work instructions (WIs), and standardized forms to define Clinical Department processes

Collaborate with Clinical, Regulatory, Safety, Quality, and other functional team members to ensure compliance of department/study activities with FDA regulations, guidelines, and principles of ICH GCP and Invivyd SOPs

Ensure GCP compliance by providing guidance and support to Clinical study leads and Clinical Study Teams

Support activities associated with QA audits: as needed, assist the clinical trial teams in responding to audit findings, ensuring appropriate root cause is performed and CAPAs are created; ensure all items are documented appropriately

Manage direct reports, as applicable

Limited travel (<20%) for site and vendor oversight

Qualification

Clinical trial managementStudy managementVendor managementGCP complianceBudget forecastingProactiveCommunicationDetail-orientedAdaptability

Required

Minimum education and experience: bachelor's degree with 5-7 years relevant experience

Local and global study management at Sponsor company

Strong oral and written communication skills

Experience with development and maintenance of study timelines and budgets

Highly adaptable, proactive, deadline and detail-oriented

High level of professional expertise through recent industry training and familiarity with good clinical practice and risk-based quality management best practices

The candidate will work independently in a fast-paced and dynamic environment

Ability to accommodate hybrid schedule with a mix of both onsite (New Haven, CT once a month) and remote working

Ability to travel up to 20% for site and vendor oversight