At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
Job Function:
R&D Operations
Job Sub Function:
Clinical Trial Project Management
Job Category:
Professional
All Job Posting Locations:
Remote (Canada), Toronto, Ontario, Canada
Job Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
We are searching for the best talent for a Senior Local Trial Manager to be located in the Greater Toronto Area (GTA) in Ontario, Canada.
This is a hybrid position for someone located in the Greater Toronto Area(GTA) in Ontario. Candidates outside of GTA may be considered on a case-by-case basis and if approved by the Company.
Remote work options may be considered on a case-by-case basis and if approved by the Company.
Purpose:
As a Senior Local Trial Manager (Sr. LTM), 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).
You will be responsible for:
- The Senior, Local Trial Manager is the primary point of contact at a country level for assigned studies and has operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities as described in GCO procedural documents.
- Responsible for coordinating and leading the local trial team to deliver quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements.
- Accountable for meeting study milestones.
- Supports local feasibility and investigator selection. Leading study start-up activities, subject recruitment and retention planning at the country level, handling Canadian study payments, spend and forecast management.
- Prepares country specific informed consent in accordance with procedural document/templates. Reviews and manages site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations.
- Reviews and approves Monitoring Visit Reports submitted by Site Managers (SMs); identifies issues and/or trends across a trial project and escalates accordingly.
- Ensures Trial Master File (essential trial documents) is complete and up to date to support audit and inspection readiness.
- Actively contributes to process improvement, training and mentoring of CTAs, SMs and other LTMs.
Qualifications / Requirements:
- Minimum Bachelor of Science, Registered Nursing, Pharmacy or equivalent degree in Biological Sciences.
- Minimum of 2 years of clinical trial management experience or a total of at least 5 years of clinical trial monitoring and/or clinical trial management experience.
- In-depth knowledge of ICH-GCP and Canadian regulations.
- Strong project management skills with focus on study deliverables, trial/site oversight, quality and timelines.
- Experience with risk-based trial management is valuable.
- Knowledge of several therapeutic areas. Experience in oncology is an asset.
- Proven skills in leadership (leading small teams and initiatives) and in the areas of judgement, risk assessment and mitigation, attention to detail, problem-solving, analysis, influencing, and innovation.
- Strong prioritization and decision-making skills.
- Ability to handle complexity.
- Flexible and able to work well in a changing environment
- Collaboration and conflict resolution skills.
- Strong team member and a self-starter with the ability to work independently.
- Excellent oral and written communication skills including strong presentation skills
- Experience and high proficiency with electronic filing, data systems and reporting
- The ability to travel both domestically and internationally, with occasional overnight, is required based on the needs of the business.
- Some experience in mentoring/coaching and providing training to other LTMs, SMs and CTAs preferred.
Required Skills:
Preferred Skills:
Business Behavior, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Give Feedback, Laboratory Operations, Medical Knowledge, Mentorship, Problem Solving, Process Oriented, Professional Ethics, Project Integration Management, Project Management, Research and Development, Research Ethics
