P2506 - Senior Clinical Data Manager

 Debiopharm is privately-owned Swiss biopharmaceutical company commitmented to research in oncology and infectious diseases in order 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 Data Management organization based at our Headquarters in Lausanne, we are looking for a

Senior Clinical Data Manager

As a Senior Clinical Data Manager, you will be responsible for overseeing the quality and progression of data management processes across clinical studies. You will ensure the timely availability of accurate, complete, and consistent clinical data to support internal decision-making while working closely with clinical trial teams. Your expertise will guide the set-up, validation, and closure of clinical study databases, ensuring compliance with all regulatory guidelines and procedural documents.

• Leading the planning and execution of data management methodologies for assigned clinical studies.
• Collaborating with study teams to implement data management strategies and practices that ensure high-quality data delivery.
• Designing and setting up electronic Case Report Forms (eCRFs) and electronic data capture (EDC) systems.
• Performing database management tasks including data validation, data cleaning, and query generation.
• Reviewing technical documents including Data Management Plans and SDTM specifications.
• Coordinating and training study teams on data management processes and tools.
• Managing the database lock process and ensuring proper archiving of clinical data.
• Monitoring data quality and ensuring compliance with GCP and applicable regulatory mandates.
• Assisting in audits and inspections, as applicable.

Requirements

• Strong academic background in a scientific or technical field, ideally at the university level.
• Minimum of 5 years of experience in clinical data management with a proven track record in leading projects and teams within the sponsor side
• First experience on Oncology Trials required
• First proven experience working as Lead Data Manager on Early Trial in Oncology is an advantage
• Proficiency with various EDC systems and related data management tools.
• Excellent project management, organizational, and communication skills.
• Adept at working collaboratively in a dynamic, complex environment.
• Fluency in English; proficiency in French is a plus.

Benefits

Debiopharm can offer you

• International, highly dynamic environment with a long term vision.
• Cross-functional collaboration at the forefront of the most advanced scientific developments in oncology and anti-bacterial industry
• Exposure to a wide variety of areas and functions within clinical development and the pharmaceutical industry
• Participation in a company where innovation, people and entrepreneurship are the fundamental keys to success.
• Proud to be an Equal-Pay certified, we ensure offering to all our employees the same opportunities

The use of external staffing agencies or recruiters requires prior approval from our Human Resources Department. The Human Resources Department at Debiopharm requests external staffing agencies or recruiters not to contact Debiopharm employees or members of the Board of Directors directly in an attempt to present candidates.

Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external staffing agency or recruiter does not create any implied obligation on the part of Debiopharm.

Debiopharm will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions.