Senior Clinical Research Manager
Johnson & Johnson
- Breda, Noord-Brabant
- Vast
- Voltijds
- 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'.
- 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