Clinical Data manager

Other

Posted 11 days ago


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

Katalyst Healthcares & Life Sciences logo

About Katalyst Healthcares & Life Sciences

Sourced by ZipRecruiter

Katalyst HealthCares & Life Sciences is a Global Contract Research Organization that provides services in Clinical Research, Manufacturing & Quaity, Regulatory Affairs Areas.. Industries Serving: Pharmaceutical Bio-Pharmaceutical Medical Device Cosmeceuticals & Cosmetics Food & Beverage Clinical Research Scientific Areas Covering: Clinical Research Manufacturing Quality & Validations Regulatory Affairs Intellectual Property Through our in-house team expertise, associates and alliances in the US, Europe and Asia, we can rapidly deliver services, technology, processes and workforce globally, either virtually or integrate into client project space, providing oversight and expertise for individual needs to total end-to-end support for all kinds of clinical trials of Pharma, Biotech, Medical Device and all other scientific products and their manufacturing.

Industry

Scientific research and development services

Company size

51 - 200 Employees

Headquarters location

South Plainfield, NJ, US

Social media



Frequently asked questions

Q: What skills or qualities help someone succeed as a Clinical Data Manager?

A: To succeed as a Clinical Data Manager, key technical skills include proficiency in Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC) systems, and data management software such as SAS or R. Additionally, strong domain-specific skills in clinical research regulations, Good Clinical Practice (GCP), and data validation are essential.\n\nSoft skills that contribute to success in this role include strong organizational and time management skills, effective communication and collaboration with cross-functional teams, and attention to detail and analytical thinking to ensure data accuracy and integrity. These strengths enable Clinical Data Managers to efficiently manage large datasets, identify and resolve data discrepancies, and maintain compliance with regulatory requirements.\n\nBy possessing these technical and soft skills, Clinical Data Managers can effectively oversee data collection, cleaning, and analysis, ultimately supporting the success of clinical trials and contributing to the growth of their careers in the pharmaceutical or biotechnology industry.

Q: What is the career path for a Clinical Data Manager?

A: A Clinical Data Manager's career path typically begins with entry-level roles such as Clinical Data Coordinator or Data Associate, where they assist in data management, cleaning, and reporting. As they gain experience, they progress to mid-level roles like Clinical Data Manager or Senior Data Coordinator, overseeing data management processes, implementing data standards, and collaborating with cross-functional teams. Senior Clinical Data Managers or Lead Data Managers then assume leadership roles, overseeing large-scale data management projects, developing data management strategies, and mentoring junior staff, ultimately positioning themselves for senior leadership or specialized roles in data science, regulatory affairs, or clinical operations.



Katalyst Healthcares & Life Sciences job posting for a Clinical Data manager in San Francisco, CA with a salary of $55 to $83 Hourly with a map of San Francisco location.