Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. We bring together more than 25,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients’ lives around the world.

For our client, a global pharmaceutical organization we are currently looking for a Senior Clinical Research Associate (phase I/II/III Oncology studies).  

Responsibilities include, but are not limited to:

• Demonstrate a commitment to quality in all aspects of monitoring and clinical research
• Monitor Investigative Sites’ adherence to GCP, ICH guidelines and local regulations, and internal policies
• Supervise the conduct of clinical studies, ensure compliance with protocols, regulatory requirements, and good clinical practice
• Build strong relationships with site personnel to ensure quality study conduct and patient safety
• Ensure subjects rights and safety are protected
• Conduct and document monitoring visits and CRO oversight visits
• Manage timely data entry and query resolution by investigative site
• Conduct timely onsite and remote Source Document Verification and Source Data Review
• Identify and mitigate issues, ensure timely escalation, and follow-up to resolution
• Review, maintain and reconcile Trial Master Files against Investigator Site Files
• Oversee Investigational Product documentation, storage, accountability and reconciliation at site
• Present and train during internal and external meetings
• Maintain trial management systems
• Effectively facilitate and negotiate contracts for assigned sites
• Manage ethics submissions per local requirements
• Provide county-specific expertise to ensure operational compliance with local regulations
• Work effectively with other departments and levels within the organization
• Identify new sites and investigators for Celgene studies
• Participate in and conduct CRO oversight
• Mentor new CRAs as needed
• May act as a Lead CRA

Skills/Knowledge Required:

• Scientific degree/education preferred
• Background in medical and/or scientific knowledge preferred
• Ability to effectively work independently with minimal supervision
• Knowledge of regulatory environment and guidelines (ICH, GCP, CFR, EU CT directive and local laws) – knowledge of the local health system
• Effective written and oral communication skills
• Evidence of problem-solving skills
• Ability to resolve routine issues effectively and independently
• Organizational, prioritization and time management skills
• Knowledge of Microsoft Office products and ability to learn other technical systems
• Ability to travel extensively, including overnight stays
• Appropriate local language skills – French and Dutch
• Fluent written and spoken English
• Ability to work effectively across cultures.
• Ability to drive a car and have a valid driver’s license – as required

Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.