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Senior Clinical Research Manager

Breda, Netherlands

Description

We are looking for a driven Senior Clinical Research Manager to join our growing Clinical Operations team in The Netherlands (Breda) and Belgium (Beerse). In this role, 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 trial delivery in immunology, site engagement, staff development, training/onboarding and resource management. You are responsible for the successful execution of trials from country feasibility through study close-out while keeping clear oversight of quality & performance indicators, timelines 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 and who likes to bring change. 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 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 start-up, execution and monitoring of trials in assigned therapeutic area(s). Empower your team to deliver and think out of the box. Ensure inspection readiness at all times, adherence to ICH-GCP, local legislation and relevant SOP's. Support your team in site engagement, 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 inspire change in the local organization; Cultivate an environment that encourages shared learning, out of the box thinking and a "Yes we can!"-mentality. 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.
  • Helps shaping the Dutch Clinical Trial Landscape
  • Participates in special (global) initiatives as assigned. May assume additional responsibilities or special initiatives such as 'Champion' or ''Subject Matter Expert'.

Education and Experience Requirements:

  • 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 desirable.
  • Proven leadership & communication skills - Ability to champion 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 (Key sites, trade association, authorities and ethics committees).
  • 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 English and Dutch

About Johnson & Johnson

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/.

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.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

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

Req - Internal Description

Internal Description


We are looking for a driven Senior Clinical Research Manager to join our growing Clinical Operations team in The Netherlands (Breda) and Belgium (Beerse). In this role, 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 trial delivery in immunology, site engagement, staff development, training/onboarding and resource management. You are responsible for the successful execution of trials from country feasibility through study close-out while keeping clear oversight of quality & performance indicators, timelines 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 and who likes to bring change. 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 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 start-up, execution and monitoring of trials in assigned therapeutic area(s). Empower your team to deliver and think out of the box. Ensure inspection readiness at all times, adherence to ICH-GCP, local legislation and relevant SOP's. Support your team in site engagement, 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 inspire change in the local organization; Cultivate an environment that encourages shared learning, out of the box thinking and a "Yes we can!"-mentality. 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.
  • Helps shaping the Dutch Clinical Trial Landscape
  • 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 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 desirable.
  • Proven leadership & communication skills - Ability to champion 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 (Key sites, trade association, authorities and ethics committees).
  • 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 English and Dutch

About Johnson & Johnson

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/.

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.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

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

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