Senior Clinical Trial Manager

ICON; Center Square (PA); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Health coverage

Retirement plans

Life assurance and disability

Employee assistance and wellbeing

Learning and development opportunities

Job summary

ICON Strategic Solutions seeks a Senior Local Operations Manager in HemOnc to streamline cross-functional communication across trial lifecycles. You will act as the main liaison for sites and client teams, ensuring recruitment targets, quality data, and compliant operations across country trials.

You will manage local procedures, budgets, and vendor interactions, driving CAPA and QA activities while maintaining inspection readiness and country-specific informed consent processes.

Qualifications

• BA/BS degree required with science/health focus or related field.
• HemOnc trial management experience is required.
• 3–5+ years end-to-end trial management experience in a sponsor/ CRO setting.
• Strong knowledge of ICH-GCP, SOPs, and regulatory requirements.

Responsibilities

• Serve as the primary communication point for sites and internal teams.
• Own site relationships and ensure timely patient recruitment and data quality.
• Maintain trial management systems and generate reports for oversight.
• Lead local startup activities, budgets, and contingency planning.
• Ensure regulatory and CAPA processes to support inspections.

Skills

Stakeholder management

English proficiency

ICH-GCP knowledge

Project coordination

Budget forecasting

Education

BA/BS degree

Health or science background

Tools

CTMS

eTMF

Job description

Senior Local Operations Manager - HemOnc - US

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

The Senior LOM role is a site aligned E2E partner to streamline communication across cross functional stakeholders throughout trial lifecycles.

• Serves as the primary point of communication for sites, facilitating internal client teaming to drive issue resolution.


• Intimately understands site operational model and owns relationships with critical site stakeholders to provide a voice for the site to the client's teams.

• Contribute to quality Site Selection through participation in site feasibility ensuring consistent conduct of site qualification visits and appropriate follow-up of site qualification visit report and country feasibility report. Collaborates with central study team and local stakeholders as applicable for final selection of sites to participate in trial.


• Ensures local/country team is meeting recruitment targets with high quality data on time and within study budget by providing input to study level documents and leading/coordinating local team activities in compliance with SOPs, other procedural documents and applicable regulations. This may require development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.


• Act as primary company contact for assigned trial sites, engaging with Investigator and Site Staff throughout the life of the trial.


• Focuses on investigator engagement through timely follow up with sites. Promptly communicates relevant status information and issues to appropriate stakeholders


• Focuses on investigator engagement through timely follow up with sites. Promptly communicates relevant status information and issues to appropriate stakeholders


• Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress. When necessary initiates corrective and preventive actions (CAPA) when the trial deviates from plans and communicates study progress and issues to study management teams and Quality & Compliance team.


• Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.


• Delivers competent vendor management at the country level to support the study and may submit requests for vendor services and support vendor selection. This includes reviewing and approving site and local vendor invoices as required. As required, manages the local study supply.


• Ensures high standards for study monitoring by conducting quality local trial team meetings and facilitating SM training, when needed (i.e. implementation of study amendment-and changes in study related processes).


• Contributes to patient understanding of protocol and patient safety by preparing country specific informed consent in accordance with procedural document/templates. This includes reviewing and managing site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations.


• Ensures trial subject safety in that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented, as appropriate.


• 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. When issues are identified or trends across a project are noted from MVR review, will upscale deviation issues to TDM/TDL and J&J Sponsor in timely manner.


• Accountable for ensuring quality data (accurate, valid and complete) is provided by the site and queries are resolved within expected timelines.


• Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements and developing therapeutic knowledge enough for role and responsibilities.


• With focus on quality and compliance, will work closely with SM to ensure CAPA is implemented for audits/inspections or any quality related visits. May conduct accompanied site visits with SM, if delegated by Sponsor.


• Ensure accurate finance reporting and trial delivered within budget by adhering to finance reporting deliverables and timelines. This includes forecasting and proactive management of country/local trial budget. If applicable, may assist in negotiation of trial site contracts and budgets.


• Keeps the trial in compliance with local regulatory requirements by organizing and ensuring IEC/HA approvals in cooperation with the local Start Up team, as applicable.


• May contribute as a trainer of systems/processes or provide input to functional area in process initiatives, if applicable.


• Full utilization by timely and accurate time reporting.


• Experience in management and startup of complex Early Phase trials projection with internal matrix clinical teams and sites, as applicable.


• If applicable, region specific deliverables will be specified.


• Autonomy with execution of local trial management services.


• Depth of knowledge with local trial management services.


• Process leadership.

What you need to have

• BA/BS degree.


• Degree in a health or science related field.


• 3 - 5+ years of trial end to end management experience


• Start-up & Database Locks/Cleaning experience preferred


• HemOnc experience required


• Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures.


• Strong IT skills in appropriate software and company systems


• Proficient in speaking and writing the country language and English. Good written and oral communication skills as appropriate


• To qualify, applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives


• Health and wellbeing programmes including medical, dental, and vision coverage where applicable


• Retirement and pension plans


• Life assurance and disability coverage


• Employee assistance programmes and wellbeing resources


• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.