Job Title
The Clinical Development Manager is responsible for leading and managing the daily operation of a clinical trial capabilities team in support of drug development.
The manager ensures accurate planning, prioritization across teams, and timely execution working closely with site engagement at 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 team focusing on results and driving efficiency to achieve goals and objectives.
Key Objectives/Deliverables:
* Accountable for meeting and exceeding goals for clinical trial operations for development programs.
* Accountable for ensuring compliance with local/regional requirements, data privacy requirements, and 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.
* 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 organization and with other functional groups within the company.
* 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.
Qualification Requirements:
* Bachelor's degree (preferably from legal/health science/finance/engineering field).
* Six years clinical research experience or relevant experience essential.
* 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.
* Effective communication, negotiation, and problem-solving skills.
* Self-management and organizational skills.
Additional Skills/Preferences:
* The organization focuses on the following foundational pillars across the full organization to ensure a solid and consistent approach to running our business.
* Compliance: Demonstrate a strong compliance-oriented mindset & help to build a strong compliance culture.
* People: Actively participate in the senior management team to make the organization 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.
* Customer: Demonstrate excellence in all interactions with our internal customers & business partners.
* Focus on measuring & improving our internal customer's experience with the organization.
* Continuous Improvement: Lead a culture of continuous improvement within the organization and the broader enterprise.
* Influence the Global process owners to champion continued process improvement.