Clinical Study Lead

Job Title:
Clinical Study Lead

This role will be responsible for the regional operational execution, oversight, and management of one or more clinical trials from start-up through close out for Our Client’s early-stage clinical programs. As a Regional Lead, you will work directly with cross-functional representatives including Medical Monitor, Clinical Science, Clinical Data Management, Regulatory, Biostatistics, Pharmacology, and Translational Science to ensure the successful completion of all clinical activities and project deliverables.

You will apply your technical skills and play a key role in clinical trial planning and execution, helping to grow Our Client’s pipeline.

• Support the Study Lead and Study Execution Team (SET) to ensure trials are initiated efficiently and completed on time, within budget, and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines.
• Collaborate with SET to develop, review, and facilitate RFPs, and contribute to bid defense meetings for selecting CROs and other clinical vendors.
• Manage various clinical vendors to achieve project and corporate goals on time.
• Actively manage and resolve site issues in collaboration with Our Client's functional lines and CRO partners.
• Contribute to the development and review of key clinical documents such as protocols and informed consent forms.
• Serve as a subject matter expert on various company/department initiatives and participate in SOP and process development.
• Oversee and manage vendor contracts, forecast financials, reconcile invoices, and ensure accuracy of CRO/vendor work orders.
• Participate in the implementation and oversight of clinical systems including CTMS, TMF, EDC, and IRT.
• Conduct clinical data reviews, generate queries, and participate in study activities such as site selection and start-up.
• Provide input and support in the development and review of key study documents and track study metrics.
• Proactively identify potential study risks, recommend mitigation strategies, and facilitate discussions for implementation.
• Train investigators, site staff, vendors, and team members on study protocols and trial conduct processes.
• Ensure the Trial Master File is set up and maintained, and participate in Quality Assurance and regulatory audits.
• Perform other duties as assigned.

• Bachelor's degree in life sciences or a related discipline with 6+ years of experience in clinical and drug development.
• Advanced knowledge of domestic and global clinical study management and vendor management experience in oncology.
• Experience with early phase oncology trial management, including precision medicine trials.
• Self-motivated with a focus on continuous improvement and innovative thinking.
• Results‑oriented team player with strong collaboration and relationship‑building skills.
• Detail‑oriented and creative thinker with a passion for process optimization.
• Excellent organizational, analytical, and communication skills in a fast‑paced environment.
• Ability to analyze and prioritize problems and propose solutions.
• Willingness to travel as required (up to 40%).

• Experience in site management and early phase oncology trial management preferred.
• Advanced knowledge of FDA and ICH/GCP regulations and guidelines.

Must work West Coast hours. The position can be fully remote.

This is a Contract position based out of Remote, OR.

The pay range for this position is $65.00 - $88.00/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)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplac…