Johnson & Johnson

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Originele vacaturetekst

Senior Clinical Research Manager

Job Description

We are looking for a driven Senior Clinical Research Manager to join our growing Clinical Operations team in The Netherlands and Belgium. As a Sr 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 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 +/- 150 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). 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 in EMEA.
  • 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 & negotiation skills. Willingness to engage with internal and external stakeholders (authorities, ethics committees and key sites).
  • Flexible mindset and ability to work in a fast-changing 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 Dutch, English and French (for Belgian candidates)
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 other characteristic protected by law.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Primary Location
Netherlands-North Brabant-Breda-
Other Locations
Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization
Janssen-Cilag Netherlands (8345)
Job Function
R&D
Requisition ID
2105987428W
Type vacature:
Intern

Vaardigheden

  • Er is geen minimale opleiding vereist