Audit Senior, WexfordJanuary 4, 2018
HR systems & data, CorkApril 10, 2018
Purcelloleary are working with a global organisation recruiting for the role of Operations Manager.
The Most suitable person for this role will be currently working in a scientific or health related field, two years clinical research experience or are a Nurse, Pharmacist or from a Medical Background.
Manager Operations leads and manages the daily operation of the clinical trial capabilities team in support of clinical development.
The Operations 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 Operations Manager provides leadership, direction and technical support to the Clinical Trial Capabilities assistants focusing on results and driving efficiency to achieve goals and objectives.
Qualifications – The Operations Manager :
- Bachelor’s degree preferably in a scientific or health related field, two years clinical research experience or are a Nurse, Pharmacist or from a Medical Background.
- 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
- Appreciation of / experience in compliance-driven environment
- Ability to learn and comply with financial and legal guidelines and policies (budget and contract)
- Effective communication, negotiation, and problem solving skills
- Self-management and organizational skills
- Language capabilities preferred
Key Objectives / Deliverables – The Operations Manager :
- Clinical Trial Capabilities Responsibilities
- 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 Lilly 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.
- Develop and streamline processes ensuring efficiency and improved productivity as well as meeting customer requirements
- Ensure inspection readiness through a complete, accurate and readily available Trial Master File.
- Organizational Leadership
- 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.
- People Management and Development
- 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
- Develop an organizational culture that fosters inclusion and innovation and demonstrates judgment based decision making in clinical delivery
- 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.