Senior Clinical Research Manager

2 settimane fa

Lombardia, Italia Confidenziale A tempo pieno

We are looking for a driven Senior Clinical Research Manager to join our growing Clinical Operations team in Italy. As a Senior Clinical Research Manager, you will manage a team of Local Trial Managers (Local project managers) and Site Managers (Clinical Research Associates), with a strong focus on staff performance, people development, training/onboarding and resource management. You are responsible for the successful implementation and execution of phase Ib-IIIb trials from country feasibility through study close-out while keeping clear oversight of timelines, budget, quality & performance indicators and compliance with Standard Operating Procedures (SOPs), Health Care Compliance (HCC) and local regulatory requirements. We are seeking to hire a strong leader, who is a team player, with quick learning and problem-solving abilities. You will co-create the country strategy in order to optimize ways of working, drive innovation, and strive for continuous improvement and future readiness. 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:
People management:
Provide line management to your team including goal setting, performance evaluation and talent development; Build, hire and train a fully effective team; Conduct accompanied site visits; Evaluate and forecast resource needs and manage your team's workload.
Trial delivery & oversight:
Accountable for robust feasibility processes and oversight of site selection. Responsible for implementation, execution and monitoring of trials in assigned therapeutic area(s). Deliver on your team's quality and performance objectives. Ensure inspection readiness at all times, adherence to ICH-GCP, local legislation and relevant SOP's. Support your team in issue resolution and stakeholder management. Support audits, inspections and timely CAPA resolution. Build and shape internal and external network in assigned therapeutic area.
Continuous improvement & organizational change:
Lead implementation of innovation and change in the local organization; Cultivate an environment that encourages shared learning, out of the box thinking and continuous improvement. Contribute to the development of new processes or improvement initiatives. Keep close oversight of metrics and drive follow-up actions proactively.
Coach or mentor to less experienced co-workers locally or inEMEA.
Co-develop country strategy and drive tactics to full implementation.
Leads and/or participates in special (global) initiatives as assigned. May assume additional responsibilities or special initiatives such as 'Champion' or ''Subject Matter Expert'.

**Qualifications**:
BA/BS degree in Life Sciences or related scientific field (or 8-10 years equivalent experience) - with a minimum of 8 years of Clinical Research experience in pharmaceutical industry, CRO or investigational site. Other relevant working experiences and skills may be considered by the hiring manager
At least 2 years of line management experience. Skilled in leading, hiring, training, developing and evaluating people.
Proven leadership & communication skills - Ability to foster team productivity and cohesiveness.
Solid decision-making and effective issue resolution skills; ability to generate & implement contingency plans for productivity & quality issues.
Strong interpersonal & influencing skills. Willingness to engage with internal and external stakeholders (authorities, ethics committees and key sites).
Flexible mindset and ability to work in a constantly evolving environment with the ability to collaborate and handle multiple priorities in a matrix environment.
Strong proven understanding of GCP, local laws, and regulations.
Proficiencyin English is a mandatory requirement while knowledge ofItalian language will represent anice - to - have

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

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