Clinical Study Manager; Homebased

Clinical Study Manager (Homebased)

Responsibilities

+ Own operational accountability for study-level time, cost, and quality deliverables for a global Phase II pan-tumor trial with multiple indications and stages.

+ Lead the development and maintenance of the clinical study plan, including critical path activities, interdependencies, and timelines, using Microsoft Project or similar project management tools.

+ Develop and drive the cross-functional Clinical Study Oversight Plan under the guidance of the study team leader, and ensure consistent adherence by internal teams, CROs, and vendors.

+ Provide operational input into protocol profiles, final protocols, and protocol amendments, ensuring feasibility and operational excellence across global regions.

+ Lead and coordinate document review for protocols and amendments, and support or lead related medical writing tasks such as informed consent forms, CRF guidelines, investigator brochures, safety communications, DSURs, and IND-related documents.

+ Lead CRO and vendor selection in collaboration with the study team and outsourcing/procurement, ensuring alignment with study needs, timelines, and budget.

+ Develop and manage CRO scopes of work in partnership with outsourcing/procurement, clearly defining deliverables, timelines, and quality expectations.

+ Lead trial feasibility and site identification activities with the CRO and study team, and oversee the site qualification process to ensure high-quality investigative sites.

+ Monitor clinical trial performance and quality metrics at global, country, and site levels; regularly share metrics with the study team, Operations Program Lead, and senior leadership, and ensure appropriate corrective or preventive actions.

+ Identify, triage, and resolve operational issues and risks at the study level, and escalate to the Operations Program Lead, study team leader, or governance bodies as needed.

+ Ensure adherence to internal SOPs and processes across study planning, conduct, close-out, and reporting activities.

+ Proactively assess potential risks to timelines, quality, and budget, and propose and implement risk mitigation strategies.

+ Monitor the study budget against trial progress, identify deviations, and raise them with the Operations Program Lead and study team leader.

Essential Skills

+ Minimum 7+ years of clinical operations experience within a pharmaceutical or biotechnology company.

+ Proven experience leading Phase II or Phase III global clinical studies, including complex, multi-indication oncology trials.

+ Recent, hands-on oncology solid tumor experience, including indications such as colorectal, cervical, gynecologic, gastrointestinal, pancreatic, and breast cancers.

+ Robust experience in clinical trial study start-up, including site identification, feasibility, qualification, and activation across multiple regions.

+ Demonstrated success in designing and implementing patient enrollment and enrollment-boosting strategies at global and regional levels.

+ Extensive experience overseeing and managing CROs and third-party vendors, including selection, scope of work development, performance management, and quality oversight.

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Experience with global studies beyond the US and EU, with strong understanding of Asia-Pacific and Latin America clinical trial operations.

Work Environment

This is a 100% remote role, with a strong preference for candidates based in the Eastern Time Zone

Job Type & Location

This is a Contract to Hire position based out of Durham, NC.

Pay and Benefits

The pay range for this position is $85.00 - $95.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:  - Medical, dental & vision
- Critical Illness, Accident, and Hospital  - 401(k) Retirement Plan
- Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)  - Short and long-term disability
- Health Spending Account (HSA)  -…