Janssen Inc, a company of Johnson & Johnson is hiring an Associate Director, Local Trial Management within the Canadian Global Clinical Operations Research & Development team. The position can be officed-based (Toronto) or primarily home-based with Ontario or Quebec as a preferred location.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Inc. is part of the Janssen Pharmaceutical Companies.
As an Associate Director, Local Trial Management you will be accountable for strategic and operational management and successful country (Canada) execution of Phase 1-4 clinical trials across multiple therapeutic area(s), including resource allocation, adherence to timelines and budget, compliance with relevant Standard Operating Procedures (SOPs), policies, Health Care Compliance (HCC) and local regulatory requirements. You will report to and support the Local R&D Head in shaping and leading the Global Clinical Operations (GCO) organization in Canada.
You will be responsible for:
Direct line management of 10-15 Local Trial Managers (Canadian Project Manager for the trials).
Oversight of execution of clinical trials through all phases (from feasibility to close-out) and ensuring inspection-readiness across multiple therapeutic area(s).
Hiring, onboarding and ensuring training of new staff.
Oversight of staff performance, development, training, project assignments, workload distribution and supports issue resolution with LTMs and study teams.
Ensuring quality and consistency of process across Local Trial Management team.
Providing strategic intelligence for study/country feasibility process and ensuring country trial commitments and milestones are met for assigned projects.
Ensuring alignment of local goals with global trial and organizational objectives.
Contributing to development, evaluation and implementation of new processes and systems to improve study management.
Development and management of partnerships with key study sites/Institutions, investigators; key local teams (local Medical Affairs, Strategic Partnerships, Regulatory); and with global study team partners
Fostering a culture of continuous improvement and innovation within the local GCO team
Minimum Bachelor of Science (B.Sc.), R.N., or equivalent degree in Biological Sciences
Minimum of 10 years of clinical research experience acquired in pharmaceutical industry, CRO or investigational site
At least 2 years of line management experience required
Skilled in leading, hiring, training, developing and evaluating people
Solid decision-making and financial management skills
Effective issue resolution and ability to generate and implement contingency plans for both productivity and quality issues when required
Excellent knowledge of drug development, clinical research operations and regulatory requirements including ICH-GCP, HCC and applicable regulations
Knowledge of several therapeutic areas (oncology experience preferred)
Ability to synthesize and evaluate data generated from various reports and sources
Demonstrated skills in leadership and effective communication with various internal and external partners
Flexible approach and ability to work in a fast paced and constantly evolving environment
Strong interpersonal and negotiating skills
Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment
An asset if bilingual (English and French)
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.
North America-Canada-Ontario, North America-Canada-Quebec
Janssen Inc. (7710)