Senior Local Trial Manager

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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) within the assigned TA, which will be decided based on workload distribution.

You will have operational oversight of assigned protocols from start-up through 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 and to the training and mentoring of Clinical Trial Assistants (CTAs), Site Managers (SMs), and other Local Trial Managers (LTMs).

The LTM may also have some site management responsibilities.

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

You will be part of a hardworking, enthusiastic, and committed team of more than 100 people, eager to deliver and help improve the lives of millions of patients.

PRINCIPAL RESPONSIBILITIES:

1.

Collaborate with the MCO for protocol and site feasibility assessment.

Implement consistent pre-trial assessment visit approach.

Set predictable and realistic start up timelines.

2.

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

Develop and implement contingency plans proactively and drive issue resolution in a timely manner.

3.

Act as subject matter expert for assigned protocols.

Develop strong therapeutic knowledge.

4.

Act as primary country contact for a trial.

Establish and maintain excellent working relationships with external organisations and internal partners, including Medical Affairs.

5.

Review and approve monitoring reports.

Prepare country-specific informed consent forms.

Lead and oversee the regulatory process with Ethics Commit...