Senior Clinical Data Manager

With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the leading company solely dedicated to skin and advancing the future of dermatology.

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients and the healthcare professionals we serve every day. We aim to empower each employee and to promote their personal growth all the while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy and personal rights of every employee.

At Galderma, we actively give our teams reasons to believe in our ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create unparalleled, direct impact.

Job Description

As part of the Global Biometrics team, under the responsibility of the Manager of DM & Clinical Programming , our new Senior Clinical Data Manager will be responsible for leading and overseeing all data management activities for in-house and outsourced clinical trials.

Job Responsibilities

• Operational leadership of data management tasks for assigned studies from start up to close out (including but not limited to eCRF design & edit checks, UAT, data management plan, data review & reporting, medical coding, data import/export, transformation to SDTM, database lock)
• Ensure adequate documentation and application of internal and industry standards best practices across studies
• CROs and Vendors oversight for all DM related activities providing consistent team direction/guidance and monitoring quality of work through key performance metrics
• Represent data management at cross-functional team meetings providing accurate study status updates and proactive communication/escalation of data management issues and risks
• Participate in Data Management department infrastructure, by contributing to SOPs/Work Instructions development, CRF standards development and cross-functional process improvement initiatives.
• Support PM & Contracts on budget related activities
• Mentoring of junior staff

Minimum Requirements

• Minimum seven (7) years of clinical data management experience in the Pharma/Biotech industry
• Extensive technical experience using EDC systems (ideally Medidata RAVE)
• Strong experience in CRO and vendor oversight with consistent track record of on-time quality deliverables
• In-depth knowledge of DM industry standards, best practices and CDISC implementation (CDASH, ODM, SDTM)
• Bachelor’s degree or higher in the scientific, life sciences or computer sciences field or related discipline
• Strong and effective oral and written communication skills and interpersonal skills to effectively collaborate in a cross-functional team environment
• Ability to adapt and manage competing and rapidly changing priorities
• Fluent English (oral and written)