Job Information
J&J Family of Companies Functional Manager (Clinical Research Manager), Early Development & Clinical Pharmacology (ED&CP) in North Rhine Westphalia, Germany
Functional Manager (Clinical Research Manager), Early Development & Clinical Pharmacology (ED&CP) - 2406188698W
Description
Functional Manager (Clinical Research Manager), Early Development & Clinical Pharmacology (ED&CP)
Location: Neuss, Germany
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 https://www.jnj.com/.
The Functional Manager Early Development and Clinical Pharmacology (ED&CP) is responsible for strategic and operational management and successful country execution of ED&CP (phase 0-IIa) trials across multiple therapeutic areas, including resource allocation, adherence to timelines and budget, compliance with relevant SOPs, policies, Health Care Compliance and local regulatory requirements. The ED&CP FM is accountable for shaping and managing local organizational ED&CP structure to ensure its optimal efficiency and demonstrates an effective issue management. This individual is responsible for line management of Trial Managers (TMs), Site Managers (SMs), Clinical Trial Assistants (CTAs) and/or other GCO staff as required. You will oversee staff performance, development, training, project assignments, workload distribution and support issue resolution with direct reports. The FM ensures alignment of local goals with organizational objectives, and drives innovative solutions and process improvements for ED&CP organization and GCO/GCDO overall.
Are you ready to join our team? Then read further!
Role & Responsibilities:
Staff Management:
Manage and develop staff, including setting goals, performance evaluation, and talent growth.
Interview, hire, train, and develop team members.
Provide coaching and mentorship, including site visits.
Ensure staff compliance with processes and document training.
Support staff in resolving issues and communicating with stakeholders.
Resource Management:
Assess and allocate resources for projects.
Collaborate with resource managers for hiring and onboarding staff.
Review and approve expenses per company policies.
Leadership and Strategy:
Demonstrate strong leadership and encourage idea sharing.
Develop and execute long-term strategies.
Implement and communicate organizational changes.
Clinical Trial Oversight:
Oversee clinical trials from planning to close-out, ensuring compliance and inspection readiness.
Ensure adherence to regulatory and company standards.
Report and manage compliance and ethical issues.
Relationship Building:
Build and maintain strong relationships with internal and external stakeholders.
Enhance country ED&CP capabilities and collaborate on study placement.
Quality and Performance:
Oversee site selection and feasibility processes.
Review performance metrics and drive follow-up actions.
Ensure quality oversight and inspection readiness.
Financial Management:
- Manage budget and financial reporting accurately.
Process Improvement:
Collaborate on local processes and regulatory requirements.
Develop and implement process improvements.
Promote a culture of continuous improvement and innovation.
Cultural Leadership:
- Uphold a Credo-based culture within the team.
Qualifications
Education & Experience
Scientific Degree (BSc) required.
Minimum of 8 years of clinical research experience acquired in pharmaceutical industry, CRO or investigational site! ED&CP previous clinical trial experience is preferred.
Effective communication and leadership skills. Ability to foster team productivity and cohesiveness.
Experience in mentoring/coaching others (line management experience desirable). Skilled in leading, hiring, training, developing and evaluating people.
Solid decision-making and financial management skills.
Effective issue resolution and ability to generate and implement contingency plans for both productivity and quality issues when required.
Excellent knowledge of drug development, clinical research operations and regulatory requirements including ICH-GCP, HCC and applicable regulations.
Ability to synthesize and evaluate data generated from various reports and sources.
Demonstrated skills in effective communication with various internal and external stakeholders (e.g.investigational sites, ethics committees, health authorities, etc.).
Flexible mindset and ability to work at a fast paced in a fast-changing environment in different therapeutic areas. Operates under limited supervision.
Proficient in English language. Computer literacy. Strong interpersonal and negotiating skills.
Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment. Perform activities in a timely and accurate manner.
Willingness to travel regionally/globally up to 25%.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Primary Location Europe/Middle East/Africa-Germany-North Rhine Westphalia-Rhein-Kreis Neuss
Organization Janssen-Cilag Germany (8000)
Job Function Clinical Trial Project Management
Req ID: 2406188698W