Senior Local Trial Manager

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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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 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. 

 

 

Required Skills:

 

 

Preferred Skills:

Business Behavior, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Give Feedback, Laboratory Operations, Medical Knowledge, Mentorship, Problem Solving, Process Oriented, Professional Ethics, Project Integration Management, Project Management, Research and Development, Research Ethics

  

 

The anticipated base pay range for this position is:

€39 800,00 - €64 055,00

 

 

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

 

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

 

 

Additional information:

39 800,00 - 71 600,00 EUR Annual