Job Description
Apex Pharmaceuticals is at the forefront of biopharmaceutical innovation. We are currently seeking a highly skilled Sr. Clinical Data Manager to join our dynamic Clinical Operations team in Durham, NC. In this pivotal role, you will ensure the integrity, accuracy, and compliance of clinical trial data throughout the drug development lifecycle. You will work closely with cross-functional teams to design, implement, and maintain data management strategies that meet global regulatory standards.
If you are a strategic thinker with a passion for data integrity and a desire to make a tangible impact on patient outcomes, we want to hear from you.
Responsibilities
- Lead the data management strategy for Phase II-IV clinical trials, ensuring alignment with study protocols and timelines.
- Oversee the creation and maintenance of Data Management Plans (DMPs) and CRF (Case Report Form) designs.
- Manage the end-to-end data lifecycle, including data entry, cleaning, validation, and release.
- Ensure strict adherence to Good Clinical Practice (GCP) and regulatory guidelines (FDA, EMA, ICH).
- Collaborate with Statistical Programming, Medical Writing, and Clinical Operations teams to resolve data queries efficiently.
- Mentor junior Data Managers and contribute to the continuous improvement of data management processes.
Qualifications
- Bachelor’s degree in Life Sciences, Biology, Nursing, or a related field; Master’s degree preferred.
- Minimum of 5+ years of experience as a Clinical Data Manager in the pharmaceutical or biotechnology industry.
- Strong proficiency with Electronic Data Capture (EDC) systems, such as Oracle Clinical (Rave), Medidata Rave, or REDCap.
- Experience with SAS, SQL, or R for data manipulation and analysis is highly desirable.
- Deep understanding of GCP, ICH guidelines, and regulatory submissions.
- Excellent communication skills with the ability to present complex data concepts to diverse audiences.