Job Description
Are you a detail-oriented professional passionate about accelerating life-saving therapies? Apex BioPharma Solutions is seeking a highly skilled Senior Clinical Data Manager to join our dynamic team in Philadelphia.
In this pivotal role, you will oversee the integrity, accuracy, and security of clinical data throughout the drug development lifecycle. We are looking for a leader who thrives in a fast-paced environment and possesses a deep understanding of regulatory standards (FDA 21 CFR Part 11) and data management methodologies.
Why join us?
- Competitive salary and comprehensive benefits package.
- Work on groundbreaking therapeutic programs.
- Flexible hybrid work schedule.
- Professional development and certification reimbursement.
Key Responsibilities:
- Lead the end-to-end data management lifecycle for Phase II-IV clinical trials, ensuring alignment with project timelines and objectives.
- Oversee the design, validation, and implementation of Electronic Data Capture (EDC) systems, with a focus on Rave or Oracle Clinical.
- Ensure strict adherence to Good Clinical Practice (GCP) and regulatory guidelines (ICH E6 R2) to maintain data integrity and audit readiness.
- Collaborate cross-functionally with Clinical Operations, Biostatistics, Medical Writing, and QA teams to resolve data discrepancies and optimize data collection processes.
- Develop and manage Data Management Plans (DMPs) and perform comprehensive data quality reviews (e.g., source data verification support).
- Mentor junior data managers and provide training on data standards and tools.
- Implement and maintain data security measures to protect patient privacy and proprietary information.
Qualifications:
- Master’s degree in Life Sciences, Pharmacy, Nursing, or Informatics, or a Bachelor’s degree with significant relevant experience.
- Minimum of 5-7 years of experience in Clinical Data Management within the pharmaceutical or biotechnology industry.
- Professional certification (CDMP, CDMPi) is highly preferred.
- Proficient in EDC systems (Rave, Oracle Clinical, Medidata Rave) and data manipulation tools (Excel, SQL, SAS, R, or Python).
- Strong understanding of SDTM data standards and CDISC implementation.
- Excellent problem-solving skills and the ability to communicate complex data concepts to non-technical stakeholders.
- Proven track record of leading cross-functional teams and managing projects in a regulated environment.
Responsibilities
- Lead the end-to-end data management lifecycle for Phase II-IV clinical trials, ensuring alignment with project timelines and objectives.
- Oversee the design, validation, and implementation of Electronic Data Capture (EDC) systems, with a focus on Rave or Oracle Clinical.
- Ensure strict adherence to Good Clinical Practice (GCP) and regulatory guidelines (ICH E6 R2) to maintain data integrity and audit readiness.
- Collaborate cross-functionally with Clinical Operations, Biostatistics, Medical Writing, and QA teams to resolve data discrepancies and optimize data collection processes.
- Develop and manage Data Management Plans (DMPs) and perform comprehensive data quality reviews (e.g., source data verification support).
- Mentor junior data managers and provide training on data standards and tools.
- Implement and maintain data security measures to protect patient privacy and proprietary information.
Qualifications
- Master’s degree in Life Sciences, Pharmacy, Nursing, or Informatics, or a Bachelor’s degree with significant relevant experience.
- Minimum of 5-7 years of experience in Clinical Data Management within the pharmaceutical or biotechnology industry.
- Professional certification (CDMP, CDMPi) is highly preferred.
- Proficient in EDC systems (Rave, Oracle Clinical, Medidata Rave) and data manipulation tools (Excel, SQL, SAS, or Python).
- Strong understanding of SDTM data standards and CDISC implementation.
- Excellent problem-solving skills and the ability to communicate complex data concepts to non-technical stakeholders.
- Proven track record of leading cross-functional teams and managing projects in a regulated environment.