Associate Director, Clinical Operations - Cambridge, United States - Harbinger Health

Description

Job Description –

Associate Director, Clinical Operations

Position Summary

As an

Associate Director, Clinical Operations

at Harbinger Health, you will oversee the management of clinical trials from their inception to completion, expertly guiding both internal and external multidisciplinary teams.

Reporting to the SVP of Clinical Operations you will drive trials forward, ensuring adherence to timelines and fostering collaboration across functions.

Your leadership will be instrumental in liaising with CROs and vendors, providing oversight, managing compliance with study plans, and maintaining seamless execution, all within the framework of Harbinger Health's innovative clinical landscape.

Responsibilities:
Lead and represent the study team in designing, developing, and delivering clinical trials within established timelines.

Strategically plan and coordinate with cross-functional teams for optimal execution of clinical trials.

Act as the primary point of contact for CROs and vendors, providing critical oversight and management.

Maintain rigorous compliance with study plans, monitoring clinical studies through direct communication with CROs and investigator sites.

Assure compliance with internal SOPs, FDA regulations and GCP

Regularly update on clinical trial progress, managing budgets and timelines diligently.

Manage clinical data collection, clinical trial supply delivery, and Trial Master File oversight to ensure readiness for inspections.

Participate in document reviews, including protocols and clinical study reports, and contribute to RFPs and CRO/vendor selection processes.

Identify potential study issues, formulating proactive contingency plans.

Mentor team members and manage direct reports, fostering professional growth.

Perform additional duties as required by the evolving needs of the organization.


Basic Qualifications:
Bachelor's degree in health science or a related field.

6+ years of experience in clinical trial management.

Proficient communication, organizational, and problem-solving skills.

Advanced skills in Microsoft Office Suite and a keen eye for detail.

Demonstrated knowledge of ICH guidelines, GCP, and global regulatory requirements for clinical trials.

Proven ability to collaborate effectively both internally and externally.

Experience in facilitating project team meetings and ensuring stakeholder alignment.

Willingness to travel approximately 20%.


Preferred Qualifications:
Experience in Oncology, Diagnostics, and/or Liquid Biopsy.

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