# Sr. Site Management Associate

**Company**: ICON Strategic Solutions
**Location**: Indianapolis, IN
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/Indianapolis-IN/Sr-SMA_JR164259?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/job/sr-site-management-associate-22dc54c8-d0c/

## Description

As a Senior Site Management Associate at ICON, you will play a crucial role in supporting Principal Investigators (PIs) and site teams during the enrollment, maintenance, and close-out phases of clinical trials.

**Clinical Trial Execution & Site Support**

- Serve as the primary point of contact for site administration and logistical needs during enrollment and maintenance and Data Base Lock (DBL).

- Collaborate closely with PIs and study coordinators to troubleshoot technical and administrative activities and issues.

- Ensure timely site support and sustained engagement through consistent communication, proactive problem-solving, and appropriate follow-up.

- Track and monitor documentation and systems information to ensure compliance and quality standards are maintained.

- Support protocol amendment releases, mass mailings and communications, and provide guidance and documentation as needed.

- Assist sites with navigation or troubleshooting of sponsor systems and escalate complex issues to system Subject Matter Experts (SMEs).

- Support dissemination of training materials related to protocol changes, systems updates, or new tools introduced during enrollment/maintenance.

- Field questions and provide refresher guidance to sites on processes such as eCRF entries, IWRS use, SIP data entry.

**Regulatory & Documentation Oversight**

- Support maintenance and update of the Trial Master File (TMF) with essential enrollment and maintenance documentation to ensure inspection readiness.

- Ensure documentation of patient-related activities, deviation handling, and site correspondence aligns with GCP and internal SOPs.

- Flag inconsistencies or delays in data entry, document completion, or other quality-related indicators for follow-up.

- Support sponsor audits and inspections by preparing and providing site interaction documentation as needed.

**Operational Efficiency & Collaboration**

- Collaborate with monitors, CRLs, and cross-functional teams to identify unique and trending needs, operational risks, and site administrative feedback.

- Utilize internal tracking tools and systems to ensure real-time visibility into site status/compliance.

- Provide input into continuous improvement efforts by sharing insights and feedback from sites.

- Prioritize workload based on study milestones, enrollment timelines, and site needs.

- Design and implement solutions to create lasting fixes through automation, process change, or quality improvements.

**Required qualifications and experience**

- Bachelor's degree in life sciences, clinical research, or a related field.

- Understanding of clinical trial processes, Good Clinical Practice (GCP), and regulatory requirements.

- Knowledge of clinical trial conduct and ICH Good Clinical Practice (GCP).

- Experience coordinating site study activities, visits, documents, and participant workflows.

- Experience maintaining essential records and accurate study system information.

- Experience supporting investigators and site staff with study requirements and issue resolution.

- Experience reviewing colleagues' work and providing technical guidance on clinical research site operations.

**Preferred qualifications and experience**

- Bachelor's degree preferably in a scientific or health-related field or a minimum of 5 years equivalent experience.

- Minimum of two (2) years pharmaceutical industry OR clinical research experience.

- Systems experience (Veeva, TMF) highly preferred.

- Understanding of the overall clinical development paradigm.

- Applied knowledge of customer service and/or project management processes and skills.

- Appreciation of/experience in compliance-driven environment.

- Effective communication, negotiation, and problem-solving skills.

- Self-management and organizational skills.

- Aptitude to learn and engage in process automation and generative AI.

- Ability to streamline processes with technical solutions.

- Experience with innovative methodologies to enhance efficiency in clinical research.

**Rewards & Benefits**

- Competitive base salary and performance-related incentives.

- Health and wellbeing programs including medical, dental, and vision coverage where applicable.

- Retirement and pension plans.

- Life assurance and disability coverage.

- Employee assistance programs and wellbeing resources.

- Learning and development opportunities through structured training and career pathways.

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## Skills

### Required
- Good Clinical Practice (GCP)
- clinical trial processes
- regulatory requirements
- life sciences
- clinical research

### Nice to have
- Veeva
- TMF
- customer service
- project management
- compliance-driven environment
- process automation
- generative AI

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