Description
Office With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Accountable for achieving the final clinical deliverable (usually clean data from evaluated patients as specified in the study protocol) within the time period specified in the contract with the customer. Interprets data on project issues and makes good business decisions with support from experienced team members or line manager. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. ~ Contributes to the development of the Master Action Plan (MAP) for providing clinical related documents. ~ Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). ~ Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. ~ Bachelor's degree or equivalent and relevant formal academic / vocational qualification In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Solid interpersonal and problem solving skills to enable working in a multicultural matrix organization Effective oral and written communication skills, including English language proficiency Solid understanding of relevant regulations e.g. Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Ability to use and learn standard office equipment and technology with proficiency. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. Please include your contact information and specific details about your required accommodation to support you during the job application process. *
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