|Job title :||Head of Clinical Data Management|
|Job type :||Permanent|
|Contact name :||Yanick Millet|
|Contact email :||email@example.com|
- Developing the Data Management and Database Programming department and support the team
- Leading policies and procedures within the departement to ensure compliance with GCP, regulatory guidelines, etc.
- Managing oversite with third vendors party
- Managing resources allocation and timelines
- Developing and tracking timelines to ensure the deliveries
- Developing and communicating standardize procedures, sharing best practices and participating in or leading continuous improvement efforts.
- Providing support to Senior Management in setting objectives and leading the Clinical Data Management team to achieve the business goals.
- Dealing with representative in audits and regulatory inspections.
Skills and Competencies:
- (MSc or PhD) in Life Sciences, Computer Science or related discipline.
- Minimum 8 years of experience in Clinical trials, preferably in Clinical Data Management.
- Solid understanding of end-to-end clinical development process.
- Proven experience working with External Service Providers in the area of outsourced clinical studies.
- Extensive experience in clinical research and development and in GCP in DM
- Sound understanding of regulatory guidelines in a pharmaceutical research setting, including ICH GCP training.
- Strong leadership and mentoring skills.