Sr. LTM

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:
Milano, Italy

Job Description:

We are looking for a driven Senior Local Trial Manager (LTM) to report to the Manager Clinical Operations (MCO), running assigned clinical trials (phases 1-4) in Oncology.

You will have operational oversight of assigned protocols from start-up through to database lock/ closure of the trial.

You will be responsible for coordinating and leading the local trial team to deliver quality data and trial documents that are aligned with Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory standards.

The LTM actively contributes to process improvement; training and mentoring of Site Managers (SM) and Local Trial Manager (LTM) roles.

The LTM may have also some site management responsibilities.

You need a flexible mindset and have the ability to work in a constantly evolving environment.

You will be part of a hardworking, enthusiastic, and committed team eager to deliver and helping to improve the lives of millions of patients.

Principal Responsibilities:

Collaborate with the MCO for protocol and site feasibility assessment.

Implement consistent pre-trial assessment visit approach.

Set predictable and realistic start up timelines.

Lead and coordinate local trial activities and project planning activities to meet site open and recruitment targets and to deliver high quality data on time and within study budget.

Develop and install contingency plans in a proactive way and drive issue resolution in a timely matter.

Act as subject matter expert for assigned protocols.

Develop strong therapeutic knowledge.

Act as primary country contact for a trial.

Establishes and maintains excellent working relationships with external organisations and internal partners, including Medical Affairs.

Review and approve monitoring reports.

Prepare country specific informed consent forms.

Lead and oversee regulatory process with Ethics Committees and Health Authorities.

Keep oversight on or initiate corrective and preventive actions.

Encourage and empower trial teams to deliver on the trial commitments.

Keep patient engagement and safety central to all activities.

Contribute and encourage process improvement at every opportunity.

Leads and/or participates in special initiatives as assigned.

May assume additional responsibilities or special initiativ...