Top 10 Sr. clinical data manager Jobs in Boulder Co

Sr. Clinical Data Manager
Katalyst Healthcares & Life Sciences —Boulder, CO
- Contract
- Nursing
- Bachelor's degree
- Senior level
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Senior Manager, Clinical Operations
Cerapedics, Inc. —Westminster, CO
- $146,000 - $210,000 a year
- Remote
- Analysis skills
- Bachelor's degree
- Travel
- Disability insurance
- Health insurance
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Sr. Manager, People Analytics
DAVITA —Denver, CO
- $98,000 - $155,000 a year
- Full-time
- Office
- 3 years
- SQL
- Health insurance
- Dental insurance
Applied AI Health System Engineer – Senior Manager
PRICE WATERHOUSE COOPERS —Denver, CO
- $124,000 - $280,000 a year
- Azure
- HIPAA
- 8 years
- Paid holidays
- Health insurance
Applied AI Health Data Architect-Senior Manager
PRICE WATERHOUSE COOPERS —Denver, CO
- $124,000 - $280,000 a year
- HIPAA
- 8 years
- SQL
- Paid holidays
- Health insurance
Applied AI Health Data System Engineer-Senior Manager
PRICE WATERHOUSE COOPERS —Denver, CO
- $124,000 - $280,000 a year
- 6 years
- HIPAA
- SQL
- Paid holidays
- Health insurance
Healthcare Payer AI Decision Science Manager/Senior Manager
Accenture —Denver, CO
- $87,400 - $293,800 a year
- Full-time
- Azure
- Management
- Computer Science
- Paid holidays
- Disability insurance
Healthcare Provider AI Decision Science Manager/Senior Manager
Accenture —Denver, CO
- Full-time
- Azure
- Computer Science
- 5 years
- Paid holidays
- Disability insurance
Data Engineer, Senior
Releady —Denver, CO
- $60 - $70 an hour
- Full-time
- Hybrid work
- 5 years
- SQL
- Bachelor's degree
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2d
Senior Data Scientist Engineer - SFL Scientific
Deloitte —Denver, CO
- $128,000 - $252,500 a year
- Full-time
- Azure
- Computer Science
- Office

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Sr. Clinical Data Manager

Katalyst Healthcares & Life Sciences -
Boulder, CO

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Job Details

Contract

Qualifications

Research project team leadership
Data integrity assurance
Project development phase management
Data systems development
Data validation techniques
Database testing
Testing and evaluation
Employee relationship building
ICH guidelines
Clinical research compliance
Bachelor's degree
Database change management
CDISC standards
Managing clinical research teams
User acceptance testing
Clinical quality assurance standards
FDA regulations

Full Job Description

Responsibilities:

Provide leadership, strategic planning, direction and implementation of clinical systems for data collection which may include vendor selection, budgeting, resource planning, vendor oversight, EDC build and study timelines, etc.
Perform or provide oversight to staff for all CDM activities from study startup to archival: design CRFs/eCRFs, create Data Validation Specifications, Data Management Plans, eCRF Completion Guidelines, and Data Review Plans, code terms in MedDRA and WHO Drug; and complete data base lock, archival, and closeout activities
Develop and manage standard operation procedures (SOP and CLPs) for clinical investigation data management; Data Management Plans (DMP), eCRFs, user acceptance testing (UAT) plans and scripts; EDC build and associated edit checks
Provide study level metrics/reports and external data reconciliation processes relating to CRF review, query status, data entry, monitoring status, management of independent review vendors, and any other relevant matters; translate metrics into performance assessment and opportunities
Collaborate with cross-functional team and management to implement and govern CDM processes and standards to meet all applicable quality requirements and regulations, manage and oversee all phases of data management activities
Provide program/study level oversight and expertise for CDM activities for multiple studies
Review clinical data on an ongoing basis to ensure consistency, integrity and accuracy; assess and identify key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns
Establish external data reconciliation processes; develop CDM processes for management and determination of adjudication for independent review of video-endoscopies, CT scans
Evaluate and manage CROs and external technology vendors to meet company's goals and CDM standards
Build and drive positive relationships and teamwork within the clinical team and partnering sites with professional demeanor
Make decisions and chart course through careful evaluation of risks and benefits with limited information in conjunction with leadership; serve as the interdepartmental subject matter expert for the CDM area
Evaluate and manage CROs and external technology vendors to meet company's goals and clinical data management quality standards on an ongoing basis
Assist with routine quality audits as applicable

Requirements:

Bachelor's Degree in scientific discipline (RN or advanced degree preferred)
9 years' industry experience in CDM in all study phases and activities from startup to archival with at least 5 years in lead role for clinical development programs with medical devices leading toward FDA filing / approvals
Thorough knowledge of the CDM standards for medical devices (Class III PMA devices preferred)
Expertise in development, validation, and management of the clinical study database throughout its life cycle, from CRF design, database development and testing, discrepancy management, data quality review, and database close and lock procedures, CDASH and SDTM data formats
Working knowledge of the GCP, ICH and FDA guidance and regulations for clinical trials
Working knowledge of the MedDRA and WHO Drug dictionary coding terms Able to complete tasks independently, accurately, and efficiently with attention to detail and in a timely manger
Experience in implementing, validating, and administrating other clinical systems for data collection (e.g., eSource, IVRS, IWRS, core lab web-based portals)
Demonstrated ability to manage complex projects with tight timelines and overcome project roadblocks
Excellent verbal and written communication skills

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Refine Your Search

sr. clinical data manager jobs in boulder co

Sr. Clinical Data Manager

Senior Manager, Clinical Operations

Sr. Manager, People Analytics

Applied AI Health System Engineer – Senior Manager

Applied AI Health Data Architect-Senior Manager

Applied AI Health Data System Engineer-Senior Manager

Healthcare Payer AI Decision Science Manager/Senior Manager

Healthcare Provider AI Decision Science Manager/Senior Manager

Data Engineer, Senior

Senior Data Scientist Engineer - SFL Scientific

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