Job Description
<p>Apex BioPharma Solutions is seeking a visionary Senior Clinical Data Manager to join our elite team in the heart of Boston. We are at the forefront of transforming healthcare through innovative data management strategies. In this pivotal role, you will oversee the integrity, quality, and delivery of clinical datasets that power life-saving drug development programs. You will mentor a team of junior data managers and work closely with cross-functional stakeholders to ensure regulatory compliance and operational excellence.</p><p>If you are passionate about data integrity, possess a keen eye for detail, and thrive in a fast-paced, high-tech pharmaceutical environment, we want to hear from you.</p>
Responsibilities
- <ul><li>Lead the design, development, and validation of clinical database systems, ensuring they meet CDISC SDTM and DEFINE specifications.</li><li>Oversee data quality assurance (DQA) processes, performing comprehensive data cleaning and validation checks to ensure 100% auditability.</li><li>Manage the data management lifecycle, from CRF design and data entry to database lock and data transfer to biostatistics.</li><li>Ensure strict adherence to FDA 21 CFR Part 11, EMA GCP, and internal SOPs regarding data security and privacy.</li><li>Mentor and coach junior data managers, providing technical guidance on programming languages and database tools.</li><li>Facilitate effective communication between clinical operations, biostatistics, and medical writing teams to resolve data discrepancies.</li><li>Participate in regulatory inspections and prepare necessary documentation for audits.</li></ul>
Qualifications
- <ul><li>Bachelor’s or Master’s degree in Life Sciences, Bioinformatics, Statistics, or a related field.</li><li>Minimum of 5-7 years of progressive experience in Clinical Data Management within the pharmaceutical or biotechnology industry.</li><li>Advanced proficiency in programming languages such as SAS, R, or SQL.</li><li>Extensive knowledge of clinical trial processes, database design concepts, and CDISC standards (SDTM, DEFINE, XML).</li><li>Strong understanding of GCP (Good Clinical Practice) and regulatory requirements (FDA, EMA, ICH).</li><li>Proven track record of leading cross-functional teams and managing complex database projects.</li><li>Excellent problem-solving skills and the ability to work under tight deadlines in a regulated environment.</li></ul>