About the role

Senior Local Trial Manager managing clinical trials from start-up to closeout in the Greater Toronto Area. Join Johnson & Johnson in developing innovative medicines and enhancing patient care.

Responsibilities

Be 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.
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.

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.