Senior Local Trial Manager

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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 14) 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 Committees and Health Authorities. Maintain oversight of or initiate corrective and preventive actions.

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

7. Keep patient engagement and safety central to all activities.

8. Contribute to and encourage process improvement at every opportunity. Lead and/or participate in special initiatives as assigned. May assume additional responsibilities or special initiatives such as Champion or Subject Matter Expert.

9. Coach or mentor less experienced colleagues.

EDUCATION AND EXPERIENCE REQUIREMENTS:

- A minimum of a BA or BSc degree in Life Sciences Nursing or related scientific field (or equivalent experience) is required.

- You have gained experience in clinical trials and preferably in site monitoring and have experience of project management tasks.

- Ability to travel with occasional overnight stay away from home.

- You have proven leadership skills effective communication skills and digital literacy.

- The ability to lead initiatives/small teams.

- Proficient in Italian and English.

BENEFITS:

We offer a competitive salary and an extensive benefits package. The health and well-being of our employees is a priority; we offer a flexible working environment as we value work-life balance. We also offer career development opportunities for those who want to grow and be part of our organization. We are Janssen!

Johnson & Johnson Family of Companies is an equal opportunity employer and all qualified applicants will be considered for employment without regard to any other characteristic protected by law.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process to perform crucial job functions and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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