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  • 2 weeks ago

jobs description

(Senior) Clinical Research Manager (m/w/x)

Location:
Vienna, Austria

We are looking for a driven (Senior) Clinical Research Manager to join our growing Clinical Operations team in Austria and Switzerland.
The alpine countries are embedded and organized in a D-A-CH concept with Germany completing the cluster of countries. We are conducting the rich portfolio of global clinical trials in the D-A-CH region.
As a (Senior) Clinical Research Manager, you will manage a team of e.g.

composed 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 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 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. Deep expertise within assigned therapeutic area(s) and/or other area of responsibility to conduct an effective study placement in the D-ACH region. Utilize professional networks to ensure effective interaction with relevant in
- and external stakeholders
• Responsible for implementation, execution, and monitoring of trials in assigned therapeutic area(s) with innovative compounds. 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 followup actions proactively
• Coach or mentor to less experienced coworkers locally or in EMEA
• Codevelop country strategy and drive tactics to full implementation
• Lead and/or participate 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 810 years equivalent experience) with a minimum of 8 years of recent Clinical Research experience in pharmaceutical industry, CRO or investigational site
• At least 2 years of line management experience (medium to large size team of direct reports). Skilled in leading, hiring, training, developing and evaluating people
• Proven leadership & communication skills
• Ability to foster team productivity and cohesiveness
• Solid decisionmaking and effective issue resolution skills; ability to generate & implement contingency plans for productivity & quality issues
• Strong interpersonal & influencing skills. Capable to install a professional and robust working network to ensure effective interaction with relevant in
- 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
• Proficient in local language and 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. We are Janssen
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will be considered for employment without regard to any oth
Vienna Austria

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