Clinical Data manager Job at Katalyst HealthCares & Life Sciences, San Francisco, CA

T2dwRndxYkh4U3UrNTZqdnZYYm9CUTdzY1E9PQ==
  • Katalyst HealthCares & Life Sciences
  • San Francisco, CA

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 - 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, CFR Part 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 #J-18808-Ljbffr Katalyst HealthCares & Life Sciences

Job Tags

Similar Jobs

Titan Medical Group

Travel Nurse RN - Rehab in Apex, NC Job at Titan Medical Group

 ...Registered Nurse (RN) | Rehab Location: Apex, NC Agency: Titan Medical Group Pay: Competitive weekly pay (inquire for details) Shift Information: Days - 3 days x 12 hours Contract Duration: 52 Weeks Start Date: 6/8/2026 About the Position... 

Patterns Behavioral Services, Inc.

Board Certified Behavior Analyst (BCBA) Albany NY Job at Patterns Behavioral Services, Inc.

Requirements Patterns Behavioral Services, Inc. - Identifying Patterns, Changing Trajectories Hiring a Part Time BCBA to join our growing team in Albany, NY! WHO WE ARE Patterns Behavioral Services is a center-based, in-home, and school provider of behavioral services to...

Roche

Account Executive Job at Roche

 ...Account Executive - Tissue Diagnostics At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are... 

Fountain

Valet Trash Collector - Pickup Truck or Trailer Required Job at Fountain

Valet Trash Collector - Pickup Truck or Trailer Required Fetch Package Compensation $51.00 - $60.00/dayJob Type Contract freelancerIndustry Environmental and wasteDescription As a Trash Service Partner you will be responsible for collecting and disposing of trash/recycling... 

Acenda, Inc.

Bachelors Intern Job at Acenda, Inc.

## Bachelors InternApplylocations: US NJ Pennsville Township 364 South Broadwaytime type: Part timeposted on: Posted Yesterdayjob requisition id: JR100950**If you want to make a living by making a difference, join Acenda as an**Intern**Job Title: Bachelors Intern - Family...