Company:
Debiopharm Group
Location: Lausanne
Closing Date: 23/10/2024
Salary: 80.000 - 100.000
Job Requirements / Description
Debiopharm
is a privately-owned Swiss biopharmaceutical company committed to research in oncology and infectious diseases to improve patient outcomes and quality of life. Debiopharm International SA aims to develop innovative therapies via our unique “development only” business model, acting as a bridge between disruptive discovery products and patient access in international markets. At Debiopharm, you will be at the forefront of the fight against cancer and infectious diseases through working on innovative medicines for patients. Join our team at Debiopharm where together, we innovate, we impact, and we grow. For our Biometry organization based at our Headquarters in Lausanne, we are looking for a Senior Clinical Data Manager – Contractor 8 months The Senior Clinical Data Manager is accountable for the quality and timelines of data management activities for assigned clinical studies, including studies for which data management activities are outsourced to external providers. He/she ensures timely availability of complete, accurate, and consistent clinical data to support the internal decision-making process. He/she is a key member of the clinical study team and is responsible for performing and/or overseeing the set-up, maintenance, control, cleaning, validation, and closure of clinical study databases, in compliance with Procedural Documents (e.g., Policies, Standard Operating Procedures (SOP), and regulatory guidelines). He/she works closely with Clinical Trial Managers and the other study team members and provides efficient data management support to the study team. Your responsibilities will be but not limited to: Define and manage timelines on multiple clinical studies or development programs for Clinical Data Management (CDM). Coordinate/perform CDM activities for assigned studies/programs, including electronic Case Report Form design, Electronic Data Capture (EDC) system set up, user acceptance testing (UAT), user training, database release, data review, query generation, and data coding. Prepare/review oversight plans, data management plans, data validation plans, and other study-specific procedures and guidelines in line with existing business processes and procedural documents. Ensure appropriate study-specific training is provided to assigned study teams and documented. Ensure ongoing and timely data capture and data cleaning activities, including external data sources. Provide/coordinate data management support to clinical study teams to keep up ongoing data review and monitoring. Lock, transfer, and archive clinical study databases. Ensure data quality is according to industry standards and data integrity principles. Ensure that data management activities are compliant with GCP and applicable regulatory guidelines, processes, and Procedural documents. Act as referent for transversal activities (coordination of SOP review, be the CDM representative). Your profile Scientific or technical education background, ideally university level. Experience of 10 years minimum in clinical data management, with strong experience using several EDC systems and related tools and technologies. Experience leading data management studies and teams to deliver quality databases that meet regulatory requirements. Good planning, organizational, and communication skills. Ability to effectively work and collaborate in a complex matrix organization. Fluent in English, good knowledge of French is an asset. Debiopharm can offer you: Possibility to work from home with weekly visits to the office (Lausanne). The opportunity to join a successful company at the forefront of the most advanced scientific developments in the industry and be exposed to many areas within clinical development and the pharmaceutical industry. The possibility to be in a company where innovation, people, and entrepreneurship are the fundamentals of its success. Proud to be Equal-Pay certified, we ensure offering to all our employees the same opportunities.
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is a privately-owned Swiss biopharmaceutical company committed to research in oncology and infectious diseases to improve patient outcomes and quality of life. Debiopharm International SA aims to develop innovative therapies via our unique “development only” business model, acting as a bridge between disruptive discovery products and patient access in international markets. At Debiopharm, you will be at the forefront of the fight against cancer and infectious diseases through working on innovative medicines for patients. Join our team at Debiopharm where together, we innovate, we impact, and we grow. For our Biometry organization based at our Headquarters in Lausanne, we are looking for a Senior Clinical Data Manager – Contractor 8 months The Senior Clinical Data Manager is accountable for the quality and timelines of data management activities for assigned clinical studies, including studies for which data management activities are outsourced to external providers. He/she ensures timely availability of complete, accurate, and consistent clinical data to support the internal decision-making process. He/she is a key member of the clinical study team and is responsible for performing and/or overseeing the set-up, maintenance, control, cleaning, validation, and closure of clinical study databases, in compliance with Procedural Documents (e.g., Policies, Standard Operating Procedures (SOP), and regulatory guidelines). He/she works closely with Clinical Trial Managers and the other study team members and provides efficient data management support to the study team. Your responsibilities will be but not limited to: Define and manage timelines on multiple clinical studies or development programs for Clinical Data Management (CDM). Coordinate/perform CDM activities for assigned studies/programs, including electronic Case Report Form design, Electronic Data Capture (EDC) system set up, user acceptance testing (UAT), user training, database release, data review, query generation, and data coding. Prepare/review oversight plans, data management plans, data validation plans, and other study-specific procedures and guidelines in line with existing business processes and procedural documents. Ensure appropriate study-specific training is provided to assigned study teams and documented. Ensure ongoing and timely data capture and data cleaning activities, including external data sources. Provide/coordinate data management support to clinical study teams to keep up ongoing data review and monitoring. Lock, transfer, and archive clinical study databases. Ensure data quality is according to industry standards and data integrity principles. Ensure that data management activities are compliant with GCP and applicable regulatory guidelines, processes, and Procedural documents. Act as referent for transversal activities (coordination of SOP review, be the CDM representative). Your profile Scientific or technical education background, ideally university level. Experience of 10 years minimum in clinical data management, with strong experience using several EDC systems and related tools and technologies. Experience leading data management studies and teams to deliver quality databases that meet regulatory requirements. Good planning, organizational, and communication skills. Ability to effectively work and collaborate in a complex matrix organization. Fluent in English, good knowledge of French is an asset. Debiopharm can offer you: Possibility to work from home with weekly visits to the office (Lausanne). The opportunity to join a successful company at the forefront of the most advanced scientific developments in the industry and be exposed to many areas within clinical development and the pharmaceutical industry. The possibility to be in a company where innovation, people, and entrepreneurship are the fundamentals of its success. Proud to be Equal-Pay certified, we ensure offering to all our employees the same opportunities.
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Debiopharm Group