Address
Form of work Responsibilities:
- Develop requirements for EDC including CRF and system design; performs and organizes all aspects of the Clinical Database build and cross-functional User Acceptance Testing (UAT).
- Develop report specifications for routine data reviews; assist with programming and QC of output.
- Perform routine data quality activities including review of standard study reports, query identification and resolution, and recommendations for improved data cleaning and collection.
- Collaborate with cross functional study team for data reviews and data cleaning activities.
- Maintain user accounts in compliance with regulatory requirements and SOPs.
- Review/revise DM related study plans including Data Quality Management Plan, Data Validation Plan, Data review plan, eCRF Completion Guidelines, and other study documents to ensure quality and standardization.
- Provide strategic input into the design of data flow across EDC and non-EDC data sources.
- Creatively define, develop, implement and enforce use of systems that simplify and improve Clinical Data capture and quality.
- Knowledge of industry standards (CDISC, SDTM, CDASH).
- In-depth understanding of Data Management regulatory guidelines: ICH, GCDMP, 21CFR Part 11.
- Proven ability to pre-emptively identify data and system issues, and mitigate risks to data quality.
- Knowledge and experience with development, validation, execution, maintenance, documentation, and archival of Clinical Data.
- Experience in development and implementation of Clinical data management standards and procedures.
- Experience with web-based EDC (IBM Clinical preferred), Clinical Data management systems and medical coding dictionaries such as MedDRA and WHO Drug.
- background in programming is preferred.
- BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics or equivalent industry experience.
- Strong expertise in project/program management including stakeholder management.
- 6 years of data management experience in the pharmaceutical or biotechnology industries.
- Highly detail oriented with special attention to quality and quality control.
- bility to multitask and handle multiple responsibilities simultaneously; able to prioritize.
- Excellent problem resolution and organizational skills; desire to improve upon established processes.
- Strong interpersonal skills, including verbal and written communication, are essential.
- bility to work independently and as part of a team
