Global Accounts, Senior Account Executive (Spain, United Kingdom, Ireland)

Shopify Inc.; Tarragona; Presencial; EUR 70.000 - 90.000; Jornada completa

Descripción de la vacante

Join a leading organization in oncology clinical research as a Regional Manager for Clinical Quality Assurance. You'll be responsible for maintaining quality management systems and ensuring compliance across European sites. Ideal candidates will have significant experience in oncology trials and a strong understanding of regulatory standards. This role offers a chance to contribute to groundbreaking cancer treatments and support the mission of bringing hope to patients worldwide.

Formación

• 8-10 years of experience in oncology clinical research.
• In-depth knowledge of EMA and FDA regulations.
• Proficient in handling audits and CAPA processes.

Responsabilidades

• Maintain centralized Clinical Quality Management System.
• Lead internal audits to promote inspection readiness.
• Develop KPIs and Quality Metrics for continuous improvement.

Conocimientos

Knowledge of GCP

Experience with clinical trial management systems

Audit and inspection handling

Educación

Bachelor's degree or equivalent

Herramientas

Clinical trial management systems (CTMS)

Electronic data capture (EDC)

Descripción del empleo

The START Center for Cancer Research (“START”) is the world’s largest early phase site network, fully dedicated to oncology clinical research. Throughout our history, START has provided hope to cancer patients in global community practices by offering access to cutting edge trials throughout the US and Europe. Today, with over 1,300 studies completed, and with research facilities in the United States and in Spain, Portugal, and Ireland, START’s mission is to accelerate the development of new anticancer drugs that will improve the quality of life and survival for patients with cancer and lead to its eventual cure. To date, over 43 therapies conducted at START locations have obtained FDA / EMA approval.

Incredibly, while Academic Medical Centers (AMCs) conduct 80% of cancer trials, such trials reach only 20% of the patient population – leaving the majority of patients who are treated in community practices and hospitals without access to a clinical trial when their care journey calls for one. START serves the many – by bringing cancer trials to physicians and their patients in community hospitals and practices when hope is needed most.

START represents the world’s largest roster of Principal Investigators (PIs) across its eight clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world.

We are hiring a Regional Manager, Clinical Quality Assurance

• Facilitate the maintenance of the START centralized Clinical Quality Management System (CQMS) across the European Sites.
• Develop, review and update Network Standard Operating Procedures (NSOPs) in collaboration with Global QA and site operational leadership.
• Review and approval of Site Standard Operating Procedures (SSOPs) in collaboration with Global QA and site operational leadership.
• Facilitation of SOP training for new issuance of SOPs, SOP revisions and harmonization initiatives.
• Lead internal auditing activities to identify and mitigate areas of potential risk, and promote audit / inspection readiness across the European sites.
• Perform quality checks / internal audits of regulatory training trackers (i.e. CITI GCP, EMA, HSP, and ALCOA).
• Develop and maintain quality Key Performance Indicators (KPIs) / Quality Metrics and dashboard(s) to routinely report START EU clinical research site "health" and foster continuous improvement.
• Facilitate audit / inspection preparation, conduct and response in collaboration with Global QA team for EU sites.
• Lead Root Cause Analysis and Corrective & Preventative Action (CAPA) plans for EU sites. Maintenance of Global CAPA tracker for EU sites.

Education & Experience

• Bachelor’s degree or equivalent experience in lieu of degree.
• Minimum of 8-10 years of experience in oncology, clinical research setting (preferably Phase I / Early Phase oncology trials).
• In depth knowledge of GCP, ICH guidelines, EMA and FDA regulations, and the clinical trial lifecycle. Proven experience in handling audits, inspections and CAPA processes is required. Proficient in using clinical trial management systems (CTMS), electronic data capture (EDC) systems and other relevant tools.

More about The START Center for Cancer Research

Deeply rooted in community oncology centers globally, The START Center for Cancer Research provides access to specialized preclinical and early-phase clinical trials of novel anti-cancer agents. START clinical trial sites have conducted more than a thousand early-phase clinical trials, including for 43 therapies that were approved by the FDA. START represents the world’s largest roster of Principal Investigators (PIs) across its eight clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world. Learn more at STARTresearch.com.

Ready to be part of a team changing the future of cancer treatment?

Join us in our mission to conquer cancer, one clinical trial at a time. Your expertise and dedication can help us bring hope and healing to patients worldwide. Please submit your application online.

We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

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