One of our large pharma clients is recruiting for a Clinical Trial Lead in Morristown New Jersey.
A global healthcare leader, our client has one of the most exciting product pipelines in the industry today. It is a pipeline of innovative medicines brought to life by diverse, talented, and performance driven people. All of this makes our client one of the most rewarding employers in their field. They are committed to peak performance, improving the quality of life, and embracing and leveraging diverse backgrounds, cultures and talents to achieve competitive advantage.
The Clinical Trial Lead is responsible for the operational execution of US Phase IV clinical studies, Investigator Initiated Trials (IITs), and compassionate use programs. Phase IV clinical support includes protocol development, review/reporting quality trial data, and study reporting/publishing in compliance using our client’s processes, GCP/ICH and Regulatory requirements. IIT program support includes review and approval of strategically aligned studies, and management of budget. Independently supports program level activities as assigned. This position is key to maintaining effective communication and professional relationships with internal and external clinical trial stakeholders.
Key Performance Indicators
1. Timely and quality execution of trial related activities (e.g. key milestones, 100% of target enrolment at last patient first treatment, 100% clean data). Effective management of IIT plan development and execution.
2. Timely submission and delivery of high quality clinical trial documentation.
3. Trials are executed on time, budget and in compliance with local regulations to our client’s internal standards.
4. Successful execution of complex projects involving multiple stakeholders
5. Ability to influence effectively in a highly matrixed environment to achieve desired business outcomes
6. Ability to effectively communicate
• Bachelor’s Degree in scientific or healthcare discipline is preferred, (preference for Sciences), advanced degree desirable
• 5+ years of experience in clinical research management
• Experience in a monitor role or a role overseeing clinical trials desirable
• Experience in managing a project budget required
• Strong Interpersonal skills
• Strong Project Management and Leadership skills
• Ability to work under pressure
• Ability work in a matrix environment
• Displays innovative ideas and solutions
• Highly proficient in negotiation skills
Please include the job reference number when applying.