Our client makes a difference for people the world over by discovering, developing and delivering medicines that help people live longer, healthier and more active lives. Central to all that we do are our talented and motivated professionals, circa 500 of whom are based at our Global Business Solutions centre in Little Island, Cork. There we boast vibrant workforce made up of over 35 nationalities, speaking over 27 languages.
The Clinical Trial Start Up Manager leads and manages the daily operation of the clinical trial capabilities team in support of clinical development. The Manager is accountable for ensuring accurate planning, prioritization across teams and timely execution working closely with site engagement at the affiliates and across the trial capabilities teams. The scope of the work includes activities related to investigator sites readiness; maintenance and close out ensuring country specific requirements are met. The manager is responsible for ensuring inspection readiness through a complete, accurate and readily available Trial Master File.
The manager provides leadership, direction and technical support to the Clinical Trial Capabilities assistants focusing on results and driving efficiency to achieve goals and objectives.
- Accountable for meeting and exceeding goals for clinical trial operations for development programs.
- Accountable for ensuring site initiation and maintenance activities comply with local/regional requirements, data privacy requirements and the company quality standards.
- Manage communications/relationships and serve as the point of contact for the trial capabilities team deliverables during site initiation, maintenance, and close out representing progress to business partners.
- Accountable for daily prioritisation of work to meet business needs
- Provides expertise in conducting clinical research and keeping up to date with country/regional regulatory requirements.
- Ensure inspection readiness through a complete, accurate and readily available Trial Master File
- Identify and ensure shared learning across the clinical capabilities organization and with other functional groups within the CDO
- Build capabilities in the function through the development and improvement of processes, tools and training.
- Enable a culture of continuous improvement to drive efficiency through process improvement, people skills, and shared learning
- Recruit, develop, and retain a scientific and operationally capable workforce skilled and knowledgeable in clinical development
- Effectively manage an agile organization that continuously meets the needs of a changing portfolio
- Bachelor’s degree preferably in a scientific or health related field, two years clinical research experience or relevant experience preferred
- Understanding of the overall clinical development paradigm and the importance of efficient site initiation
- Previous supervisory experience
- Strong leadership skills and ability to influence others and lead across the business
- Project management processes and skills
- Effective communication, negotiation, and problem-solving skills
- Self-management and organizational skills
- Language capabilities preferred
The GBS focuses on the following foundational pillars across the full organisation to ensure a solid and consistent approach to running our business
- Demonstrate a strong compliance-oriented mindset & help to build a strong compliance culture
- Familiarize with & influence all applicable process documentation & training materials to ensure you operate in a fully compliant manner
- Actively participate in the GBS senior management team to make the GBS a great place to work for all employees and influence the strategic direction of the center
- Engage interpersonal, communication & relationship building skills to interact with all levels of an organization
- Demonstrate excellence in all interactions with our GBS internal customers & business partners
- Focus on measuring & improving our internal customer’s experience with the GBS