Clinical Study Manager; Homebased

Position Overview

We are seeking a Clinical Operations Manager for a global Phase II pan‑tumor oncology trial. This is a 100% remote role, preferred for candidates in the Eastern Time Zone.

• 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 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 elevate 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.

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

Contract to Hire based in Durham, NC.

Pay range: $85.00 - $95.00 per hour.

• 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)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Final date to receive applications:
July 20 2026.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

San Francisco Fair Chance Ordinance:
Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector:
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.