Clinical Data Manager

About Certara

Certara accelerates the potential of bringing medicines to market and to patients using biosimulation software, technology, and services to transform traditional drug discovery and development. Our clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries. Our goal is to enable the life sciences industry’s use of data, modeling, and analytics to make better decisions across the various phases of discovery and drug development.

We are seeking a proactive, flexible and detail-oriented Junior Clinical Data Manager to support both interventional clinical trials and real-world evidence (RWE) studies. The ideal candidate has solid knowledge of clinical data workflows, a critical mindset, and strong communication skills. This role involves participation in a wide range of data management activities, including data review, reconciliation, query handling, documentation, and user acceptance testing (UAT).

Responsibilities

• Execute existing SAS programs for data listings and reconciliation; review SAS logs to confirm successful execution and elevate issues if needed.
• Support quality control of analysis datasets for modeling and simulation, against source data typically in CDISC format and dataset specifications.
• Perform data reconciliation between EDC and external sources (e.g., central lab, bioanalytical data, safety data).
• Identify, track, and resolve data queries, including communication and follow‑up with external vendors when discrepancies are found.
• Critically evaluate vendor responses and re‑engage when responses are missing or unsatisfactory.
• Participate in User Acceptance Testing (UAT) for EDC systems, helping to verify CRF functionality and edit checks prior to go‑live.
• Support regular data listing exports.
• Contribute to the development and maintenance of key Data Management documents, including: DMP, DTA, Reconciliation Plan,…
• Work cross‑functionally with clinical operations, biostatistics, medical writing, and external vendors.
• Ensure clear and timely communication with internal teams and clients on data‑related topics.

Qualifications

• Bachelor’s degree in Life Sciences, Health Informatics, or related field (Master’s preferred).
• Minimum 3 years of experience in Clinical Data Management.
• Base user of SAS software (SAS9‑Base) with proven experience in life sciences and clinical trials.
• Familiar with working with CDISC data formats.
• Strong analytical skills and critical thinking for query review, issue resolution and quality control of datasets.
• Experience with EDC systems such as Rave, Viedoc, Zelta, or Veeva.
• Knowledge of data flow from external vendors (labs, bioanalytical, safety) and experience with reconciliation processes.
• Experience participating in UAT, data exports, query management, and protocol‑driven data review.
• Excellent organizational, communication, and documentation skills.
• Eager to learn and develop.
• Ability to work in cross‑functional project teams.

Certara bases all employment‑related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.