Clinical Data Manager
- Full-Time
- Vista, CA
- Leica Biosystems
- Posted 3 years ago – Accepting applications
Job Description
Are you a Clinical Data Manager that is interested in contributing to cancer diagnostics? If so, we want to hear from you! At Leica Biosystems we are redefining the cancer diagnostics industry! In this role, you will be stimulated by challenging work and encouraged to learn every day.
The Data Manager will be responsible for data management of Clinical Affairs. This position uses the Danaher Business System and tools in the timely and high-quality execution of a clinical data management strategy for pre-market and post-market trials.
This is a Remote based position.
Responsibilities we will trust you with:
Provide data management support to clinical team, study projects, and biostatistics team.
Develop the data management plan for a clinical study and execute the data management plan throughout lifecycle of the study.
Participate in developing case report forms (CRFs).
Create database clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic, and data validations.
Develop data transfer agreement(s) between external data sources and/or labs.
Assist in database upgrades/migrations including performing user acceptance testing.
Maintain and track EDC user management and other clinical databases across allocated clinical trials, compile master user lists and activate/deactivate user accounts.
Assist in defining and/or build data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.
Perform database lock and freeze activities.
Coordinate the archiving of study databases and related documents.
Perform close-out audits
Ensures data system compliance by following the established guidelines of regulatory authorities.
Your areas of knowledge and expertise that matter most for this role:
Bachelor's or Master's degree in technical or health care area with a minimum of four years proven experience in developing and executing clinical data management procedures and detailed knowledge of clinical research.
Participate in Continuing education in clinical trial designs and monitoring procedures, FDA regulations and clinical data processing and reporting.
Strong understanding of GCP, FDA, ICH, CDISC, etc., regulations and guidelines
Effective project management skills including participating in multiple projects at different stages, prioritizing tasks, meeting project timelines, and constructive communication with cross-functional partners.
Must be motivated and able to work independently as well as, collaborate with a team in a remote work arrangement.
Travel % of Travel, include approximate overnight stays per week
Up to 10% for team meetings What we have to offer:
Check out our benefits at www.DanaherBenefitsInfo.com
This job description in no way states or implies that these are the only duties to be performed by this employee. The incumbent is expected to perform other duties necessary for the effective operation of the department or unit. This job description may be changed at any time.
At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
#LI-KL1
#LI-REMOTE
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.
Apply to this Job
The Data Manager will be responsible for data management of Clinical Affairs. This position uses the Danaher Business System and tools in the timely and high-quality execution of a clinical data management strategy for pre-market and post-market trials.
This is a Remote based position.
Responsibilities we will trust you with:
Provide data management support to clinical team, study projects, and biostatistics team.
Develop the data management plan for a clinical study and execute the data management plan throughout lifecycle of the study.
Participate in developing case report forms (CRFs).
Create database clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic, and data validations.
Develop data transfer agreement(s) between external data sources and/or labs.
Assist in database upgrades/migrations including performing user acceptance testing.
Maintain and track EDC user management and other clinical databases across allocated clinical trials, compile master user lists and activate/deactivate user accounts.
Assist in defining and/or build data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.
Perform database lock and freeze activities.
Coordinate the archiving of study databases and related documents.
Perform close-out audits
Ensures data system compliance by following the established guidelines of regulatory authorities.
Your areas of knowledge and expertise that matter most for this role:
Bachelor's or Master's degree in technical or health care area with a minimum of four years proven experience in developing and executing clinical data management procedures and detailed knowledge of clinical research.
Participate in Continuing education in clinical trial designs and monitoring procedures, FDA regulations and clinical data processing and reporting.
Strong understanding of GCP, FDA, ICH, CDISC, etc., regulations and guidelines
Effective project management skills including participating in multiple projects at different stages, prioritizing tasks, meeting project timelines, and constructive communication with cross-functional partners.
Must be motivated and able to work independently as well as, collaborate with a team in a remote work arrangement.
Travel % of Travel, include approximate overnight stays per week
Up to 10% for team meetings What we have to offer:
Check out our benefits at www.DanaherBenefitsInfo.com
This job description in no way states or implies that these are the only duties to be performed by this employee. The incumbent is expected to perform other duties necessary for the effective operation of the department or unit. This job description may be changed at any time.
At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
#LI-KL1
#LI-REMOTE
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.