Manager Clinical Operations (m/f/x)

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R&D Operations
Job Sub Function:
Clinical Trial Project Management
Job Category:
People Leader
All Job Posting Locations:
Beerse, Antwerp, Belgium, Breda, Netherlands
Job Description:

We are looking for a driven Manager Clinical Operations to join our growing Clinical Operations team in Belgium (Beerse) and The Netherlands (Breda). As a 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 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 implementation, execution and monitoring of trials in assigned therapeutic area(s). Empower your team to 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.

• Co-develop country strategy and drive tactics to full implementation.

• 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 5 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
• Experience in mentoring/coaching others (line management experience desirable). 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 & influencing skills. Willingness to engage with internal and external stakeholders (authorities, ethics committees and key sites).
• 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, Dutch and French (for Belgian candidates)