The ideal candidate will have:
1. Over 7 years of experience in Clinical Data Management within pharmaceutical and biotechnology companies
2. Proven ability to manage and oversee multiple studies simultaneously, with strong project management skills
3. Experience with both in-house studies and external vendor oversight
4. Detail-oriented with a strong focus on data quality and compliance
5. Proficient in Veeva Vault eTMF, including ongoing TMF maintenance, adherence to DIA reference models, and accurate document filing
6. Skilled in TMF quality control, with a clear understanding of compliance requirements and audit readiness
7. Familiar with Data Management Plans (DMPs), including version control, verification of signatures, and documentation standards
8. Therapeutic area experience in pulmonary and cardiovascular studies preferred
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