Clinical Data Manager
1 week ago
About Us
Apotex Inc. is a global health company committed to delivering high-quality, affordable medicines worldwide. With a presence in over 75 countries, our team of 7,200 professionals works tirelessly in manufacturing, R&D, and commercial operations.
Job Summary
This position requires an expert in pharmacokinetics and statistical analysis to implement CDISC standards, manage data management, software development, and validations. The successful candidate will perform pharmacokinetic and statistical analysis of concentration-time data and generate randomization schemes as needed.
Key Responsibilities
- Develop and validate in-house SAS programs in line with quality standards and regulations.
- Create SDTM and ADaM datasets for studies conducted by Apotex using CDISC standards.
- Annotation of CRFs for clinical studies conducted by Apotex.
- Ensure validation of software is done in line with applicable company quality standards and regulations.
- Validation and review of clinical trial data.
- Creation of specifications for Define.xml, validation, and review of SDTM, ADaM, and Define.xml.
- Creating data sets, tables, listings, and procedural comparison, sorting of source data.
- Ensure assigned work is performed in accordance with GCP, GLP, SOPs, regulatory requirements, best practices, and established safety standards.
- Prepare justification for queries from regulatory agencies and tracking of regulatory deficiencies.
- Conduct pharmacokinetic and statistical analysis of concentration-time data of bioequivalence studies in compliance with SOPs.
- Generation and review of randomization schemes.
- Preparation and/or review of 100% snapshot data.
- Preparation and review of pharmacokinetic/statistical section of Bio-study Reports in accordance with different regulatory guidance.
- Preparation of comprehensive summaries of pharmacology/toxicology information and other documents necessary for regulatory submission.
- Assist in study feasibility exercise for new projects to conduct bioavailability and bioequivalence studies.
- Request and maintain controlled copies, including coordination with QA team.
- Maintain, update, and archive study-related files and documents.
- Work as a member of a team to achieve all outcomes.
- Work in a safe manner, collaborating as a team member to achieve all outcomes.
- Demonstrate behaviors that exhibit our organizational values: collaboration, courage, perseverance, and passion.
- Ensure personal adherence with all compliance programs, including Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
Requirements
- Integrated Master's Degree in science.
- Expertise in statistical analysis, SAS, and/or bio-statistics.
- Excellent communication and interpersonal skills.
- Flexible to work.
- At least 4-5 years of industry experience in clinical trials related submissions for different regulatory agencies.
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