Job Title
CLINICAL PROJECT MANAGER II – ONCOLOGY (Sponsor Dedicated | Remote – United States)
Job Summary
Responsible for operational leadership and execution of global oncology clinical trials. Manage study from startup to closeout, ensuring compliance, timelines, and stakeholder coordination.
Key Responsibilities
- Support and partner with Clinical Study Leads and cross‑functional teams on global oncology trials.
- Lead day‑to‑day study management activities across study startup, conduct, maintenance, and closeout.
- Manage study timelines, deliverables, risks, and issue resolution.
- Oversee external vendors, CROs, central laboratories, imaging vendors, and specialty providers.
- Coordinate Clinical Trial Team meetings and drive action item follow‑up.
- Support study‑level planning, forecasting, and operational strategy execution.
- Monitor study performance metrics and proactively identify areas requiring intervention.
- Ensure inspection readiness and compliance with applicable regulations and sponsor requirements.
- Collaborate with stakeholders across Clinical Operations, Data Management, Biostatistics, Medical Monitoring, Regulatory Affairs, Safety, Supply Chain, and Quality.
- Contribute to study status reporting and executive‑level communications.
- Support achievement of study milestones, enrollment targets, database locks, and study closeout activities.
Required Qualifications
- Bachelor’s degree in a scientific, healthcare, or related field.
- 3+ years of Clinical Project Management experience supporting global oncology clinical trials.
- Experience managing studies across multiple countries and regions (North America, Europe, Asia‑Pacific, Latin America, or other global regions).
- Vendor management experience required.
- Strong understanding of clinical trial operations and study lifecycle management.
- Experience supporting Phase I‑IV oncology studies.
- Strong working knowledge of ICH‑GCP guidelines and clinical research regulations.
- Proficiency with Microsoft Office Suite.
- Ability to work effectively within global, cross‑functional matrix organizations.
Preferred Qualifications
- Experience independently leading global oncology studies.
- Experience supporting complex, multi‑regional Phase II and Phase III programs.
- Experience with early‑phase oncology studies (Phase I/Ib).
- Experience with immuno‑oncology, targeted therapies, cell therapy, or hematologic malignancies.
- Familiarity with CTMS, eTMF, IRT/RTSM, and clinical data review platforms.
- Experience working in sponsor‑dedicated or FSP environments.
Key Skills & Competencies
- Strong project management and organizational skills.
- Excellent communication and stakeholder management abilities.
- Proven ability to manage multiple priorities in a fast‑paced environment.
- Strong risk identification and mitigation capabilities.
- Detail‑oriented with a focus on quality, compliance, and execution.
- Strong collaboration skills across global teams and functions.
- Ability to influence without direct authority and drive accountability across study teams.
Clinical Phase Experience
- Phase I / First‑in‑Human Studies
- Phase I/Ib Dose Escalation Studies
- Phase II Proof‑of‑Concept Studies
- Phase II/III Registrational Studies
- Phase III Global Pivotal Trials
- Phase IV and Post‑Marketing Studies
Benefits
- Company car or car allowance
- Health benefits (Medical, Dental, Vision)
- Company match 401(k)
- Employee Stock Purchase Plan eligibility
- Commission/bonus opportunities based on performance
- Flexible paid time off (PTO) and sick time (subject to state/min required)
Salary Range
$120,000 – $135,000
EEO Statement
The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. The Company will provide reasonable accommodations to qualified candidates on a case‑by‑case basis and to any employee or applicant with a disability who is hired, promoted, or retained by the Company. The Company will provide reasonable accommodations to qualified candidates on a case‑by‑case basis and to any person with a disability who is appointed to or hired for a temporary position.