Head of Clinical Operations

Job Title: Head of Clinical Operations

Location: Spain

Reports To: Chief Operating Officer (COO) / Chief Executive Officer (CEO)

About Us:

Our partner is an innovative and rapidly growing Contract Research Organization (CRO) dedicated to providing high-quality clinical research services to the pharmaceutical, biotechnology, and medical device industries. With our headquarters in the United States and an expanding presence across Europe, we are at the forefront of driving clinical trial excellence in emerging markets. We are seeking a dynamic and experienced Head of Clinical Operations to lead and scale our clinical operations globally.

Position Overview:

As the Head of Clinical Operations, you will be responsible for the strategic direction, execution, and oversight of all clinical operations activities for our growing portfolio of clients. You will lead our clinical operations teams across the US and EU, ensuring that clinical trials are executed efficiently, in compliance with regulatory requirements, and within budget and timelines. This is a senior leadership role that will require a deep understanding of clinical trial management, strong cross‑functional collaboration, and a passion for scaling operations in a fast‑paced environment.

Key Responsibilities:

- Strategic Leadership:

- Develop and execute the clinical operations strategy to support the growth of the organization, ensuring alignment with overall corporate goals and objectives.

- Global Operations Oversight:

- Lead and manage clinical trial operations across multiple regions, ensuring seamless collaboration between teams in the US and EU. Provide oversight of trial progress, timelines, and budgets.

- Team Leadership & Development:

- Build and lead a high‑performing global team of clinical operations professionals, including clinical project managers, clinical research associates (CRAs), clinical trial managers (CTMs), and other operational staff. Foster a culture of collaboration, accountability, and continuous improvement.

- Clinical Trial Execution:

- Oversee the planning, initiation, execution, and closeout of clinical trials, ensuring adherence to Good Clinical Practice (GCP), regulatory requirements, and industry standards.

- Client and Stakeholder Management:

- Develop and maintain strong relationships with key clients, ensuring the successful delivery of clinical trials that meet or exceed client expectations. Serve as the primary point of contact for clients, presenting trial progress and addressing issues as they arise.

- Regulatory Compliance & Risk Management:

- Ensure that clinical trials are conducted in compliance with all applicable regulatory requirements, including ICH‑GCP, FDA, EMA, and local regulations. Identify and mitigate risks related to clinical trial operations.

- Budget & Resource Management:

- Oversee the financial management of clinical trials, including the creation and monitoring of budgets. Ensure resource allocation is optimized to meet project requirements and timelines.

- Process Improvement & Innovation:

- Lead initiatives to improve clinical trial operations, including the adoption of new technologies and tools to streamline processes and improve efficiency. Continuously assess and optimize operational workflows.

- Reporting & Metrics:

- Establish and monitor key performance indicators (KPIs) to assess the performance and progress of clinical trials. Provide regular updates to executive leadership and stakeholders on the status of ongoing trials.

Qualifications:

- Education:

- Bachelor’s degree in Life Sciences, Nursing, or a related field (advanced degree preferred).

- Experience:

- Minimum of 10 years of experience in clinical operations, with at least 5 years in a senior leadership role within a CRO.

- Proven track record of leading global clinical trial operations and managing clinical teams across multiple regions (US and EU).

- In‑depth knowledge of clinical trial management, GCP, regulatory guidelines, and industry best practices.

- Skills:

- Strong leadership and team management skills, with the ability to inspire and motivate cross‑functional teams.

- Excellent communication, presentation, and interpersonal skills.

- Demonstrated ability to manage complex clinical trials and deliver results on time and within budget.

- Proficient in clinical trial management systems (CTMS), eClinical technologies, and related software tools.

- Strong analytical and problem‑solving abilities.

- Travel Requirements:

- Occasional travel to Europe and other international locations as required.

Why Join Us:

- Growth Opportunities: Be part of an exciting, fast‑growing CRO with the chance to shape the future of clinical operations in an emerging global market.

- Dynamic Culture: Join a collaborative and innovative team that values creativity, excellence, and a patient‑centric approach to clinical research.

- Impact: Make a significant impact by contributing to the successful delivery of clinical trials that drive the development of life‑saving therapies and treatments.

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