Remote Associate Director: Clinical Trial Strategy & RBM

Syneos Health, Inc.; Polska; On-site; PLN 260,000 - 420,000; Full time

Job summary

Syneos Health is seeking an Associate Director, Clinical Trial Manager RWLP for a homebased role in Poland. The position focuses on leading RBM strategies, risk assessment, and cross-functional coordination to ensure patient safety and data integrity.

You will guide sponsors, manage data access, and drive continuous improvement while ensuring regulatory compliance and alignment with SOPs/WIs. Strong leadership and communication are essential.

Qualifications

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
• Master's degree or health data sciences degree preferred.
• Expert in Good Clinical Practice/ICH E6 (R2) Guidelines and/or other applicable regulatory requirements.
• Expert in Risk-Based Monitoring Strategies processes and tools preferred.
• Expert in project risk and issues management.
• Experience interacting with sponsors, including experience handling conflict and difficult conversations.
• Demonstrated ability to persuade and influence both above and below as well as internal and external
• Experience in operational efficiency and using data and metrics to drive performance and decisions.
• Must demonstrate good computer skills and be able to embrace new technologies.

Responsibilities

• Provides expert monitoring strategy, oversight and guidance to support internal teams and sponsors.
• Guides internal teams and sponsors through and documents the key decisions needed to implement a high quality, efficient risk-based monitoring (RBM) solution.
• Oversees the identification of critical data and process, the assessment of risks to protocol execution and clinical delivery, risk and issue tracking and risk and issue mitigation strategies.
• Where sponsors desire to incorporate new data sources, technologies or new/supplemental/substitute processes to support RBM, strategizes with internal team members and sponsors to agree on a ‘hybrid’ approach.
• Works with internal team members and sponsors to ensure access to data needed to execute RBM according to the agreed plan.
• Provides expert operational oversight and guidance to support prioritization of activities, reviews and monitors the work performed, metrics compliance, and development of contingency plans, among others.
• Analyzes performance and quality metrics to assure BU achievement of quality and compliance expectations related to patient safety and data integrity as well as RBM success measures.
• Functions as point of escalation for clinical, central monitoring, RBM and project risks and issues.

Skills

GCP / ICH E6 (R2)

Risk-Based Monitoring

Leadership

Project management

Data interpretation

Education

Bachelor’s degree or RN

Master’s degree preferred

Tools

MS Excel

Analytical Data Visualization Tools

Cluepoints

Medidata-CSA

Job description

Syneos Health is seeking an Associate Director, Clinical Trial Manager RWLP for a homebased role in Poland. The position focuses on leading RBM strategies, risk assessment, and cross-functional coordination to ensure patient safety and data integrity.

You will guide sponsors, manage data access, and drive continuous improvement while ensuring regulatory compliance and alignment with SOPs/WIs. Strong leadership and communication are essential.