BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics, or equivalent experience
5-7 years of data management experience in the pharmaceutical or biotechnology sectors
Strong project/program management and stakeholder communication skills
Familiarity with industry standards like CDISC, SDTM, and CDASH
Deep understanding of Data Management regulations including ICH and GCDMP
Proven track record of identifying and mitigating data quality issues
Experience in developing and implementing clinical data management standards.
Responsibilities
Manage all clinical trial data from start to finish, including database lock
Build and test electronic data capture (EDC) systems while ensuring data cleaning and resolution
Ensure smooth collection and accessibility of data across EDC and alternative sources
Maintain accuracy and compliance of clinical databases with CDISC standards
Develop and manage critical data management documentation such as data management plans and case report forms
Conduct quality checks and validation of data to ensure completeness and consistency
Collaborate closely with team members to address data-related challenges.
Benefits
Collaborative work environment within the Clinical Operations team
Opportunity to contribute to the development and validation of data management software
Engagement with cutting-edge technology in clinical data collection and management
Professional growth opportunities in a specialized field of biotechnology
Potential for impactful work in global clinical trials.
Full Job Description
Responsibilities:
Clinical Data Manager will be responsible for all aspects of clinical trial data management from study start up through database lock and study close
This includes the EDC build and user acceptance testing (UAT), study data cleaning and reconciliation, query issue and resolution, and database locks
They will ensure optimized data collection, flow and access across EDC and non-EDC data sources
They are also responsible for accuracy, consistency, completeness and CDISC compliance of all clinical databases
The role will operate as a key member of the Clinical Operations team
Develop and maintain all data management documentation, including case report forms, data management plans, edit check specifications, data review plans and data transfer agreements
Design case report forms (CRFs) for electronic data capture (EDC) systems for data collection
Perform data entry and cleaning activities, including discrepancy management and query resolution
Conduct data validation checks and implement quality control measures to ensure accuracy and completeness
Collaborate with study team members to resolve data-related issues and discrepancies
Generate and review data listings, summaries and reports for data review
Serve as a primary or backup resource for issues about data management
Ensure compliance with guidelines, Good Clinical Practice (GCP), CDISC standards and other relevant regulations
Contribute to the development and validation of data management software
Requirements:
BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics or equivalent industry experience
5-7 years of data management experience in the pharmaceutical or biotechnology industries
Strong expertise in project/program management including stakeholder management
Knowledge of industry standards (CDISC, SDTM, CDASH)
In-depth understanding of Data Management regulatory guidelines: ICH, GCDMP, 21CFR Part 11
Proven ability to preemptively 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, clinical data management systems and medical coding dictionaries such as MedDRA and WHO Drug
