Start Up Clinical Project Manager/ Local Trial

At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

We have 40,000 people around the world who show up every day to achieve the unimaginable. This work requires heart, science, and ingenuity. We never stop imagining a future where the most challenging diseases are a thing of the past

Janssen, a member of Johnson & Johnson's Family of Companies, is recruiting for a driven a Local Trial Manager/Clinical Project Manager to report to the Clinical Research Manager (CRM) of the Start up Team. This position is located in Cologno Monzese.

We are looking for a dedicated team member to complement the Start-up team within the Global Clinical Operations. You will be working on a variety of projects, supporting different therapeutic areas in the crucial phase of the site activation. You will support the team in improving the operational excellence, coordinating some specific tasks. You have a proven sense of detail, while simultaneously keeping the bigger picture in mind. Passion for the regulatory portion of clinical trials. Strong oral and written communication skills are pivotal to engage in (cross-)functional discussions. Are you ready to join our team?

You need a flexible attitude and have the ability to work in a constantly evolving environment. You will be part of a hardworking, dynamic and committed team of +100 people eager to work together helping to improve the lives of millions of patients.

**Key Responsibilities**:

- Oversee the set up of predictable and realistic start up timelines in collaboration with local study team and Therapeutic Area Local Trial Managers.
- Act as primary country contact for privacy aspects with impact on the Informed Consent form. Establishes and maintains excellent working relationships with external organisations (ie.Ethics committees) and internal partners (Therapeutic area LTMs, local privacy liaison, CCS).
- Contribute and encourage process improvement at every opportunity and act as primary driver for new capabilities, in line with the country strategy and focused on patients’ centricity and improved site experience
- Coordinate and oversee local vendor management within the Start up Team and in cooperation with Compliance Team.
- Support therapeutic areas CRMs in the feasibility process.
- Encourage and empower trial teams to deliver on the trial start up.
- Identify, communicate, and resolve issues
- Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems
- Provide feedback and shared learning for continuous improvement
- Leverage trial prioritization
- Anticipate and monitor dynamically changing priorities

**Qualifications**
Education and Experience**
- A minimum of a BA or BSc degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
- You have gained at least 4 years of experience in clinical research, preferably in the start-up phase, with exposure to regulatory environment
- Ability to travel with occasional overnight stay away from home
- You have proven leadership, communication and digital literacy
- The ability to lead initiatives/small teams
- Proficient in English

**Benefits**

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

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

That is why we in Italy are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”

**Primary Location**
Italy-Lombardia-Cologno Monzese
- **Organization**
Janssen-Cilag S.p.A. (7175)
**Job Function**
R&D
**Requisition ID**
2206019802W