Senior Associate Study Manager (Oncology) (CTM) (ISS)

ICON Strategic Solutions; United States; On-site; USD 130,000 - 170,000; Full time

Job summary

ICON Strategic Solutions is seeking a Senior Associate Study Manager to lead clinical operations support for oncology trials in a fully remote role in the United States.

The role partners with project managers, sponsors and teams, ensuring trial management activities align with ICH-GCP and SOPs, while maintaining inspection readiness and timely delivery.

Qualifications

• 4 years end-to-end trial management support experience in Oncology trials.
• Strong knowledge of ICH-GCP and SOPs.
• Experience with CTMS and eTMF/IF and regulatory filing.

Responsibilities

• Serve as primary point of contact for the Trial Management team.
• Support start-up, maintenance and closeout of oncology trials.
• Manage and prioritize deliverables to meet quality, timelines and budget.
• Review metrics and monitor team performance on projects.
• Forecast resources according to contracts and activity fluctuations.
• Oversee filing of essential documents in CTMS/eTMF.
• Maintain inspection readiness and data/document accuracy.

Skills

Trial management

Oncology experience

Regulatory knowledge

Stakeholder communication

Tools

CTMS

eTMF/IF

Job description

ICON is going to be opening 3 Clinical Trial Manager (Senior Associate Study Manager) (Sr. In house CRA) that will serve as the Clinical Operations Support Lead and subject matter expert, responsible for overseeing clinical support of assigned studies. (Full time, No Travel, Full Benefits, Salary, Fully Remote)

This position will act as the primary liaison between the Project Manager, Sponsor and Clinical Project Team ensuring smooth delivery of monitoring and site management activities. This role requires strict adherence to ICH/GCP, ICON and/or Sponsor Standard Operating Procedures (SOPs), regulatory requirements, and study protocols while maintaining inspection readiness at all times.

Job Description

• Primary point of contact supporting the Trial Management team in all aspects or running clinical trials.
• Clinical trial support, and team communication, for start-up, maintance and close out of Oncology clinical trials
• Manages and prioritizes the clinical deliverables (e.g. site selection, subject/patient recruitment/enrollment, data monitoring, etc.) to ensure that deliverables meet quality and regulatory requirements, project timelines, budget, and sponsor expectations. Maintains thorough knowledge of contract details. .
• Reviews project specific metrics and information sources to monitor Clinical project team and individual clinical project team member performance on the project.
• Forecasts according to contractually agreed units/hours, tailoring to manage fluctuation of activities throughout project duration.
• Oversees filing of study and site level essential documents by project team members to ensure that all initial or amended study information is submitted, approved and filed in accordance with the protocol, applicable guidelines and local regulations.
• May perform Monitoring activities, to include onsite, remote monitoring activities, site management and co monitoring activities. Appropriate background to complete these tasks must be evident per CV and supported by required certification (if applicable) and training (per local requirements).
• Ensures Inspection readiness by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS and eTMF/IF) according to expectations (metrics) and archiving retention requirements.

Requirements:

• 4 years of trial end to end management support experience of Oncology (Hematology) or Oncology (Solid Tumor) trials at a CRO, Pharmaceutical or biotechnology company.
• Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures.
• Trial management (e.g. CTMS and eTMF/IF) according to expectations (metrics) and archiving retention requirements.