P2617 - Senior Clinical Data Manager

Debiopharm seeks a Senior Clinical Data Manager in Lausanne to oversee data integrity, timelines, and quality for clinical studies in a full-time onsite role.

This position is responsible for ensuring the quality and timely completion of data management tasks across clinical studies. The role guarantees that complete and accurate clinical data supports internal decisions while acting as the primary guardian of data integrity, whether managing internal tasks or coordinating with external vendors.

Responsibilities

• Direct and coordinate clinical data management tasks, such as designing electronic case report forms, configuring EDC systems, conducting user acceptance testing, and releasing databases.
• Conduct data reviews, generate queries, and perform data coding to ensure prompt data capture from internal and external sources.
• Establish and monitor schedules for various studies or development programs.
• Draft and evaluate Data Management Plans and validation protocols in accordance with GCP, standard operating procedures, and regulatory standards.
• Manage the locking, transfer, and archival processes for clinical study databases.
• Collaborate closely with Clinical Trial Managers and other stakeholders within a matrix structure to contribute to the clinical study team.

Requirements

• Hold a scientific or technical degree, preferably at the university level.
• Possess a minimum of 10 years in clinical data management, including solid experience in the pharmaceutical industry and supporting Phase 1 through 3 studies within a matrix organization.
• Demonstrate strong proficiency with multiple EDC systems and initial experience or competence in automating tasks using AI.
• Show a successful history of leading data management studies and teams to produce high-quality, compliant databases.
• Exhibit outstanding organizational, planning, coordination, proactive, and communication abilities.
• Be technologically adept, particularly with digital tools and AI.
• Communicate fluently in English.

Nice to have

• A Project Management certification is considered advantageous.
• Prior experience in project management is beneficial.
• Knowledge of the French language is highly valued.

What the company offers

• Join a company where innovation, collaboration, and impact are integral to daily operations.
• Collaborate with multidisciplinary teams at the cutting edge of oncology and anti-infective development.
• Work in an inclusive and respectful environment that holds Equal-Pay certification.
• Develop professionally within a culture that prioritizes people, purpose, and performance.
• Contribute to and help shape the future of healthcare.

About the company

Debiopharm is a privately owned Swiss biopharmaceutical firm focused on science and the individuals behind each treatment. The organization aims to enhance the lives of those impacted by cancer and infectious diseases. It employs a distinctive development-only model to advance promising therapies into effective treatments.

• Focus on science and the people behind treatments.
• Mission to improve lives affected by cancer and infectious diseases.
• Operates using a unique development-only model.
• Culture of innovation, collaboration, and impact.
• Inclusive and respectful workplace.
• Equal-Pay certified.
• Values people, purpose, and performance.