Senior Manager Clinical Operations at Johnson & Johnson

Amsterdam, Utrecht, Netherlands -

Full Time

Start Date

Immediate

Expiry Date

20 Dec, 26

Salary

50000.0

Posted On

21 Sep, 26

Experience

13 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Yes

Skills

Industry

Pharmaceutical Manufacturing

Description

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 oncology, 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 and likes shaping the environment. 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.
Help 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, for candidates based in Belgium proficiency in French is also required.

Required Skills:

Preferred Skills:

Budgeting, Clinical Trial Designs, Clinical Trials, Compliance Management, Contract Management, Developing Others, Execution Focus, Fact-Based Decision Making, Inclusive Leadership, Laboratory Operations, Leadership, Process Improvements, Productivity Planning, Project Integration Management, Research and Development, Research Ethics, Resource Planning, Team Management

Responsibilities

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.
Help 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, for candidates based in Belgium proficiency in French is also required.

Required Skills:

Preferred Skills:

Budgeting, Clinical Trial Designs, Clinical Trials, Compliance Management, Contract Management, Developing Others, Execution Focus, Fact-Based Decision Making, Inclusive Leadership, Laboratory Operations, Leadership, Process Improvements, Productivity Planning, Project Integration Management, Research and Development, Research Ethics, Resource Planning, Team Management