Senior Local Trial Manager, 2 Openings
Johnson & Johnson
full-time
Posted on:
Location Type: Hybrid
Location: Toronto • 🇨🇦 Canada
Visit company websiteJob Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Responsible for project management through the assessment/selection, initiation, maintenance and closure phases of clinical trials (Phase 1 – 4 trials)
- 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
- 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
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
- Some experience in mentoring/coaching and providing training to other LTMs, SMs and CTAs preferred.
Benefits
- Hybrid work arrangements
- Ability to travel both domestically and internationally
- Health insurance
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical trial managementclinical trial monitoringproject managementrisk-based trial managementinformed consent preparationdata analysisquality assuranceregulatory compliancetherapeutic area knowledgeoncology experience
Soft skills
leadershipjudgementrisk assessmentattention to detailproblem-solvinginfluencinginnovationprioritizationdecision-makingcollaboration
Certifications
Bachelor of ScienceRegistered NursingPharmacy degreeequivalent degree in Biological Sciences