Contracting Manager negotiating competitive rates and building trusted relationships with suppliers for Intrepid travel in Japan. Leading the Contracting team and collaborating with Sales & Operations.
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.
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.
Benefits
- Flexible work arrangements
- Professional development opportunities
Job title
Job type
Experience level
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Not specified
Degree requirement
Tech skills
Location requirements
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