Job Description
Are you a detail-oriented professional passionate about accelerating life-saving therapies? BioPharma Innovations Inc. is seeking a Senior Clinical Data Manager to oversee the integrity and accuracy of clinical trial data. In this pivotal role, you will bridge the gap between statistical analysis and regulatory compliance, ensuring our data meets the highest global standards.
We offer a competitive benefits package, a collaborative environment, and the opportunity to work on cutting-edge therapeutics that impact millions of lives.
Responsibilities
- Lead the design, development, and implementation of clinical databases for Phase II-III trials.
- Ensure strict adherence to 21 CFR Part 11, GCP, and ICH guidelines for data integrity.
- Perform comprehensive data validation and cleaning to resolve discrepancies and ensure data quality.
- Collaborate closely with cross-functional teams including statisticians, medical writers, and regulatory affairs to ensure seamless data flow.
- Manage timelines and deliverables for Data Management Plans (DMPs) and CRF design.
- Liaise with Contract Research Organizations (CROs) and clinical sites as needed.
Qualifications
- Master’s degree in Biostatistics, Life Sciences, or a related scientific discipline.
- Minimum of 5 years of progressive experience in Clinical Data Management (CDM).
- Proficiency in CDISC standards (SDTM, ADaM) and data manipulation tools (R, SAS, SQL, or Python).
- Strong understanding of FDA, EMA, and ICH regulatory requirements.
- Excellent problem-solving skills and the ability to manage multiple priorities in a fast-paced environment.
- Strong communication skills, both verbal and written.