Job Description
Join ApexBio Solutions, a premier biopharmaceutical organization dedicated to pioneering life-changing therapies. We are seeking a highly skilled and strategic Clinical Data Manager to lead our data operations for Phase III and commercial-stage trials.
In this pivotal role, you will oversee the end-to-end data lifecycle, ensuring the highest standards of accuracy, compliance, and efficiency. You will collaborate with cross-functional teams of medical writers, statisticians, and regulatory affairs professionals to deliver high-quality clinical datasets that meet global regulatory standards (FDA, EMA).
Why join us?
- Work with cutting-edge technology in a state-of-the-art biotech hub.
- Competitive compensation package and comprehensive benefits.
- Opportunity to impact global patient outcomes directly.
We are looking for a detail-oriented leader who thrives in a fast-paced, collaborative environment.
Responsibilities
- Lead Data Management Strategy: Design and implement robust Data Management Plans (DMPs) and CRF designs in alignment with protocol specifications and regulatory requirements.
- Oversee Data Quality: Spearhead data validation, cleaning, and coding processes to ensure 100% data integrity and accuracy across all study databases.
- Regulatory Compliance: Ensure all data handling processes comply with Good Clinical Practice (GCP) and relevant regulatory guidelines (21 CFR Part 11, ICH E6(R2)).
- Stakeholder Collaboration: Act as the primary liaison between the Clinical Operations team, Data Operations, and Statistical Programming to resolve data queries and discrepancies efficiently.
- Vendor Management: Manage relationships with Contract Research Organizations (CROs) and external data management vendors, including monitoring performance and deliverables.
- Reporting & Documentation: Generate high-level data quality reports and maintain comprehensive documentation of all data management activities.
Qualifications
- Education: Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field; Master’s degree (MPH, MBA) or Certified Clinical Research Professional (CCRP) preferred.
- Experience: Minimum of 5-7 years of experience in Clinical Data Management within the biopharmaceutical or CRO industry.
- Technical Proficiency: Advanced knowledge of CDISC standards (SDTM, ADaM), SQL, R, SAS, or Python for data manipulation and analysis.
- Certification: Certification as a Certified Clinical Data Manager (CCDM) or similar is highly desirable.
- Soft Skills: Exceptional attention to detail, strong problem-solving abilities, and the capacity to manage multiple priorities in a fast-paced environment.
- Communication: Excellent verbal and written communication skills for presenting complex data concepts to non-technical stakeholders.