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Manager, Clinical Trial Associates (CTAs)
Requisition ID: 0464180503
Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Manager, Clinical Trial Associates (CTAs) to be located in Toronto, ON.
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, metabolic and chronic diseases and women’s health. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen Inc. is a member of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit www.janssen.ca for more information.
Global Clinical Operations (GCO) is a global organization focusing on clinical trial operations. As the Manager, Clinical Trial Associates (CTA’s) you will manage a team of clinical trial associates and administrative assistants.
- Direct functional management of a group of approximately 15 direct reports:
- CTAs (Clinical Trial Associates) – study and regulatory document specialists
- Study administrative and payment support assistants
- Accountable for successful execution of clinical trial activities related to timely and complete study and regulatory document review, tracking and filing; as well as study payments to sites
- Responsible for adherence to timelines and compliance with all GCO SOPs, policies and regulatory requirements to ensure inspection readiness at all times
- Ensures compliance with required external and internal regulations and guidelines (SOPs, ICH and GCP); assists with Global and local Compliance Quality Assurance (GCQA) audits and inspections
- Oversees resource allocation, project assignments, workload distribution and problem solving for/with direct reports
- Hires, on-boards and ensures training of new staff
- Responsible for performance and development for employees including talent development, coaching, mentoring and providing ongoing performance assessment
- Supports metrics review and necessary follow-up actions by team
- Ensures compliance with GCO training curricula and required systems
- Interacts with other team management and functions such as Quality & Compliance management.
- Ensures effective working relationship with internal/external business partners.
- Participates in special initiatives as needed and guides rollout of new processes and procedures
- Minimum BSc., R.N. or equivalent health sciences degree
- Minimum 5 years of experience in the Pharmaceutical Industry including primarily Clinical Research responsibilities
- Experience mentoring/coaching others
- Direct people management experience is an asset
- Solid problem-solving and decision-making skills
- Ability to lead hiring, training, development and evaluation of people.
- Strong knowledge on drug development, clinical research operations and regulatory requirements including GCP, ICH and local regulations (expertise in regulatory and study file documentation).
- Strong communication, interpersonal and negotiating skills.
- Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment.
- Strong technical skills with ability to synthesize and evaluate data generated from various reports and sources/systems.
Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies. Attracting, developing and retaining a workforce that reflects the diversity of our customers and communities is essential to our success. We are committed to providing a respectful, inclusive and accessible work environment where all employees have the opportunity to achieve their potential.
Janssen Inc. (7710)
Clinical Trial Administration