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Clinical Data Manager
3 months ago
Galvanize is a biomedical platform company operating at the convergence of engineering, biology, and healthcare delivery, aiming to deliver life-changing solutions to patients and their doctors. We design and develop Pulsed Electric Field Systems to achieve meaningful and lasting therapeutic outcomes for patients.
General Description
The role will be responsible for all aspects of clinical data management activities for assigned studies. This includes but is not limited to vendor oversight, development and maintenance of data capture systems, data queries and cleaning, and database lock and archiving.
Key Requirements
Education and Training:
Bachelor’s degree in life science, computer science or equivalent relevant degree or equivalent combination of education/experience in science or health-related field preferred
Minimum 5 years of experience in medical device clinical research
Oncology clinical trials experience preferred
Skills and Experience:
Prior experience in data management for clinical trials from start-up to closeout
Thorough knowledge of clinical trials and data collection and handling
Detailed oriented, with good organizational and time management skills
Ability to work effectively in team setting and independently with minimal oversight
Ability to manage multiple complex projects and priorities with minimal supervision
Excellent communication skills (verbal, presentation and written)
Key Responsibilities
- Responsible for execution of data management activities from initiation of protocol through database lock (Electronic Data Catpure (EDC) builds, User Acceptance Testing (UAT), database user administration, data cleaning, database freeze and lock, etc.) for assigned clinical trials including data management timelines and key deliverables
- Coordinate with clinical team on clinical trials database design, development, testing and documentation.
- Engage in study planning to ensure timely commencement of CRF and database design and edit checks.
- Coordinate CRF design per established standards and applicable study protocol
- Create edit check specifications, CRF completion guidelines, data management plans, data review plans, data transfer specifications, as well as any other required study-specific data management documents.
- Coordinate and perform UAT for EDC build, including but not limited to, test scripts, execution logs for UAT, edit checks, data listings, data reconciliation and/or coding and UAT summary report.
- Manage and support vendors contracted to assist in the data management aspects of the clinical trial, including, but not limited to CROs, Core Labs, EDC and ePRO providers.
- Responsible for managing the capture, quality, and analysis of data from multiple sources including eCRFs, core labs, applications, and others
- Perform data review, querying, and cleaning to minimize inconsistencies, missing data or errors
- Monitor and provide data to Clinical Operations to support clinical operational activities and reports
- Collaborate with different functional groups across the organization to ensure data integrity and consistency
- Work with study team to ensure timely project deliverables
- Report status of clinical data management activities to project teams and management
- Support preparation of data summary reports, data charts and other presentation materials as needed for reporting clinical study results for regulatory filings, publications, and presentations
- Develop and maintain study data management plans
- Ensure projects are conducted in compliance with operating procedures, GCP, ICH, Good Clinical data management practices, FDA regulations, and CDISC and FDA submission standards
What Galvanize Offers
- Medical, Dental, Vision, Life Insurance, LTD/STD
- 100% company paid medical coverage for employees
- Flexible Paid Time Off
- Paid Parental Leave
- Company sponsored 401(k)
This role pays between $125,000 and $150,000 per year, and your actual base pay will depend on your skills, qualifications, experience, and location.
Due to the nature of our business and the role, please note that Galvanize Therapeutics may require that you show current proof of vaccination against certain diseases including COVID-19.
Galvanize Therapeutics is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
