Clinical Research Manager (m/w/x) - 2406162081W

　　Description

　　Clinical Research Manager

　　(m/w/x)

　　We are looking for a driven Clinical Research Manager to join our growing Clinical Operations team in our location in Neuss (flex work arrangement - 3 days office presence, 2 HO), in the metropolitan region between Cologne and Düsseldorf. As a Clinical Research Manager, you will manage a team of Local Trial Managers (Local project managers), Site Managers (Clinical Research Associates) and Clinical Trial Assistants, 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 contribute to the creation of 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 of 100 people 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) with innovative compounds. Empower your team to 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.

　　Co-develop country strategy and drive tactics to full implementation.

　　Participates in special (global) initiatives as assigned. May assume additional responsibilities or special initiatives such as 'Champion' or ''Subject Matter Expert'.

　　Qualifications

　　Education and Experience Requirements:

　　BA/BS degree in Life Sciences or related scientific field (or 8-10 years equivalent experience) - with a minimum of 5 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

　　Experience in mentoring/coaching others (line management experience desirable). 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.

　　Very proficient local language and in English

　　For more than 130 years, diversity, equity & inclusion (DEI) have been part of our corporate culture at Johnson & Johnson and are a fundamental principle of our daily business. 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, backgrounds, and life experiences.

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

　　Therefore, we welcome all applications - regardless of gender, nationality, ethnic and social origin, religion/belief, disability, age, sexual orientation and identity. Racism and discrimination are not tolerated at our company, because Diversity, Equity & Inclusion at Johnson & Johnson means "You belong"!

　　Our goal is to offer people with disabilities a workplace that is as barrier-free as possible. We are aware that needs can be very individual. We respond to these and work closely with our representative for severely disabled employees. Severely disabled applicants will be given special consideration if they are equally qualified.

　　Primary Location Europe/Middle East/Africa-Germany-North Rhine Westphalia-Rhein-Kreis Neuss

　　Organization Janssen-Cilag Germany (8000)

　　Travel Yes, 25 % of the Time

　　Job Function Clinical Trial Project Management

　　Req ID: 2406162081W