Job Description
Are you a visionary leader in Clinical Data Management looking to make a tangible impact on patient outcomes? Apex Clinical Research is seeking a highly skilled Senior Clinical Data Manager to join our elite team in Boston. We are a cutting-edge biopharmaceutical organization dedicated to accelerating the development of life-changing therapies. In this pivotal role, you will lead data operations, ensuring the highest standards of integrity and compliance across our global trials.
As a Senior Clinical Data Manager, you will bridge the gap between clinical operations and biostatistics, driving efficiency and accuracy in the data lifecycle. If you possess a deep technical understanding of CDISC standards and a passion for regulatory excellence, we want to hear from you.
Responsibilities
- Lead the end-to-end lifecycle of clinical data management, ensuring data integrity from source to submission.
- Oversee the design, validation, and implementation of Case Report Forms (CRFs) aligned with Clinical Trial Guidelines (CTG).
- Manage complex data cleaning activities and resolve discrepancies across multiple clinical sites using SQL and validation rules.
- Lead cross-functional teams, including Data Scientists, Biostatisticians, and Clinical Operations, to drive project milestones.
- Ensure full compliance with ICH-GCP guidelines, FDA, and EMA regulatory submission requirements.
- Develop and maintain data management plans (DMPs) and data validation strategies.
- Act as a subject matter expert on CDISC standards (SDTM, ADaM) and programming languages (SAS, R, or Python).
Qualifications
- Bachelor’s or Master’s degree in Pharmacy, Biology, Biostatistics, Informatics, or a related scientific field.
- Minimum of 5+ years of progressive experience in Clinical Data Management within the biotech or pharmaceutical industry.
- Expert proficiency in CDISC standards (SDTM, ADaM) and programming languages such as SAS, R, or SQL.
- Strong understanding of regulatory submissions (eCTD) and FDA/EMA guidelines.
- Proven track record of leading high-volume clinical trials and managing large, complex datasets.
- Excellent communication skills, with the ability to present technical data to non-technical stakeholders.
- Experience with data management software including Rave, Oracle Clinical, or REDCap.