Manager Clinical Operations - TMF

Candidates must possess a Bachelor's or Master's degree in a related field, preferably in medicine, science, paramedical science, computer science, or business management. A strong understanding of the healthcare/pharmaceutical industry, digital/IT industry, including general pharma regulations (ICH-GCP, FDA, EMA, ALCOA), and industry best practices is essential. Significant experience in the pharmaceutical industry, ideally in an international role focusing on Clinical Development/Operations and Documentation Management, particularly the Trial Master File (TMF), is required. Proven experience in business/process consulting, including change and stakeholder management, is necessary. Knowledge of implementing GCP processes and systems globally, an affinity for data and digitalization with the ability to generate data-driven insights, and effective communication and presentation skills are also required. Proficiency in developing process documentation, knowledge of relevant IT solutions like Veeva Vault, experience in managing clinical trial documentation risks, and fluency in English are mandatory.