Manager leading TELUS's national fibre build - to - market engagements across Canada. Overseeing project coordination and market readiness for new communities before commercial launch.
About the role
- Senior Local Trial Manager in Immunology at Johnson & Johnson. Overseeing clinical trials and ensuring compliance while mentoring local teams.
Responsibilities
- Collaborates with Functional Manager (FM) for country protocol feasibility (if applicable) and site feasibility assessment in conjunction with CTA (if applicable), SM, and TDM/TDL.
- Implements any local criteria for site selection.
- Ensures consistent conduct of Site Qualification Visits and instruct teams on appropriate follow-up of Site Qualification Visit report and country feasibility report.
- Recommends suitable sites for selection to participate in trial.
- Collaborates with the Program Delivery Leader (PDL), TDM/TDL, local management/Country Head and other study team members to select final site list.
- Contributes input to the study management documents at a country level or initiates development of these documents for a single country trial, as per SOPs.
- Leads and coordinates local trial team activities in compliance with SOPs, other procedural documents and applicable regulations.
- Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget. Including but not limited to: development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
- Ensures that all Adverse Events (AE)/Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate.
- Maintains and updates trial management systems. Uses study tools and management reports available to analyze trial progress.
- Monitors country progress and initiates corrective and preventive actions (CAPA) when the trial deviates from plans and communicates study progress and issues to study management teams.
- May submit requests for vendor services and required to support vendor selection.
- In certain situations, may assist in negotiation of trial site contracts and budgets.
- Forecasts and manages country/local trial budget to ensure accurate finance reporting and trial delivered –within budget.
- Adheres to finance reporting deliverables and timelines.
- Attends/participates in Investigator Meetings as needed. May schedule and conduct a local/country investigator meeting. Will be expected to present and lead specific sessions and to facilitate discussion groups.
Requirements
- A minimum of a BA or BS degree in Pharmacy, Nursing, Life Sciences or related scientific field is required.
- 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.
- Good understanding of the drug development process including GCP and local regulatory requirements.
- Willingness to travel with occasional overnight stay away from home.
- Minimum of 2 years of leadership experience.
- Computer skills required.
- Proficient in speaking and writing the country language and English language.
- Excellent written and oral communication skills.
- Demonstrated potential to be influential.
- Some experience in mentoring/coaching and providing training to other LTMs, SMs, and CTAs preferred.
- Ability to lead initiative/small teams.
- Flexible mindset and ability to work in a fast-changing environment.
- Ability to work on multiple trials in parallel.
- Ability to anticipate obstacles and proactively provide solutions.
Benefits
- medical
- dental
- vision
- life insurance
- short- and long-term disability
- business accident insurance
- group legal insurance
- consolidated retirement plan (pension)
- savings plan (401(k))
- Vacation - up to 120 hours per calendar year
- Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
- Holiday pay, including Floating Holidays - up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
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