Senior Local Trial Manager (2 Openings)

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...