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11

April

Clinical Trial Manager

Johnson & Johnson - Australia,

Any Industry
Source: uWorkin

Source: uWorkin

JOB DESCRIPTION

Job Description

The Clinical Trial Manager ensures regional/global clinical operations deliverables progress according to agreed upon timelines and milestones. This includes country & site feasibility and site selection, trial set-up, study execution and trial closure and vendor set up activities as assigned by the GTL (Global Trial Lead). The CTM will support the GTL in leading related CRO country & site activities.

Duties/Responsibilities

Leads the Study Management Team (SMT), drives issue resolutions, and provides updates to all Trial Team members on results.

Ensures that (SMT) operates in a constant state of inspection-readiness.

Ensures required reports are generated and available for real time status tracking.

Contributes to data collection to support the site selection process

Establishes enrolment commitments and ensures actual enrolment meets projected commitments across the regions at the clinical trial level.

Ensures the availability of robust recruitment/contingency plans are in place for each region

Ensures timely and accurate documentation and communication of study progress and issue escalation.

Set-up country budgets and supervise actuals vs forecast for Out of Pocket Expenses, and review assigned vendor invoices/spend.

Creates and updates study-specific documents such as Monitoring Guidelines, Informed Consent Form, Investigational Medicinal product (IMP) related documentation, Blinding Plan, country and site feasibility related documents, Safety related documents, Protocol Deviations and Issue Escalation processes, External Service Provider Oversight Plan, Filing and Archiving Plan.

Ensures creation of appropriate trial-specific training materials and requirements, making them available to the regional/site/CRO staff and delivering training as needed.

Ensures compliance with Global Health Authority regulations and guidelines and internal operating procedures and processes. Participate in preparation for, and conduct of, Health Authority inspections and internal audits.

Coordinates data cleaning with some supervision towards a timely and successful database lock

Participates in Global Clinical Development Initiatives as assigned. Can act as a Subject Matter Specialist

Qualifications

Required Minimum Education: BS degree or equivalent

Minimum of 4 years clinical operations experience in the pharmaceutical industry or CRO

Strong project planning/management and effective communication skills.

Proven track record in successfully managing various aspects of trials from start-up to database lock

Previous experience in coordinating global or regional teams

Consistent track record to cultivate team productivity and cohesiveness.

Effective leadership skills and ability to manage multiple partners.

Able to proactively identify and preempt budget issues and work with key partners to resolve.

Detail orientated with strong analytical skills.

Experience with management and supervision of CROs/vendors is preferred.

What We’re About:

We are passionate about our work and play vital roles across a range of professional disciplines. We care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers! We share a kind of DNA where we’re each:

Committed to caring

Responsible to our communities

Ready to apply our knowledge and know-how

Unique in our background and experiences

The drivers of our own success

Passionate about doing what’s right

Make a unique mark in your career!

If you want to be seen for the talent you bring to your work, be the driver of your own career, and work with others who share your passion for caring and success, then we invite you to join the Johnson & Johnson Talent Community by visiting www.careers.jnj.com