Johnson & Johnson Careers
Senior Local Trial Manager
Requisition ID: 3060190822
Janssen Inc, a company of Johnson & Johnson is hiring a Senior Local Trial Manager. This position is a home-based role.
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. Passionate about 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.
As a Senior Local Trial Manager, you will be part of our Global Clinical Operations (GCO) Canada group within Research & Development and will be responsible for project management through the assessment/selection, initiation, maintenance and closure phases of clinical trials (Phase 1 – 4 trials). Responsibilities include:
- Overall project management of the Canadian component of multicentre, international registration studies and/or Medical Affairs studies (Phases 1-4).
- Providing leadership to the local study team (e.g. Regional Site Managers/Monitors, document specialists, admin support).
- Accountability to Global study team for trial coordination and meeting study deliverables.
- Supporting local feasibility and investigator selection. Leading study start-up activities, subject recruitment and contingency planning at the country level, timely acquisition of quality data and trial documentation; handling study spend and forecast management.
- Ensuring Trial Master File (essential trial documents) is complete and up to date to support audit and inspection readiness.
- Participate in the development and improvement of departmental procedures and processes in the scope of the company’s effort towards continuous quality improvement.
- Minimum Bachelor of Science, Registered Nursing or equivalent degree in Biological Sciences
- Minimum of five years in Clinical Research including trial management experience in clinical trials (phases 2 and 3 at minimum).
- Experience with risk-based trial management is an asset.
- In-depth knowledge of ICH-GCP and Canadian regulations
- Strong project management skills with focus on study deliverables, trial/site oversight, quality and timelines
- Knowledge of several therapeutic areas is valuable
- Demonstrated skills in leadership and in the areas of judgement, risk assessment and mitigation, attention to detail, problem-solving, analysis, negotiation, and innovation.
- Strong prioritization, decision-making, communication skills, and flexibility. Ability to handle complexity. Flexible and able to work well in a changing environment
- Collaboration and conflict resolution skills
- Excellent oral and written communication skills including strong presentation skills
- Experience and high proficiency with electronic filing, data systems and reporting
- Strong team member and self-starter with the ability to work independently
- Ability to travel up to 10% both domestic and international, based on the needs of the business is required
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 important 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