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Related keywords
- Senior Clinical Data Manager
- Clinical Bioinformatics Data Manager
- Clinical Data Manager
- Clinical Data Management Specialist
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- Manager Clinical Data Management
- Lead Clinical Data Manager
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- Clinical Data Management Analyst
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Sr Director Clinical Bioinformatics
Recruited by Illumina 10 months ago
Address Foster City, CA, United States
Manager, Clinical Data Management
Company | Gilead Sciences |
Address | Foster City, CA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Biotechnology Research,Pharmaceutical Manufacturing |
Expires | 2023-09-25 |
Posted at | 8 months ago |
For Current Gilead Employees And Contractors
- Addresses needs or issues with regulatory submissions and assists with responses to regulatory / compliance audits and inspections.
- Adheres to regulatory requirements, industry standards and Gilead SOPs and ensures the same across own team.
- Trains and mentors less experienced in colleagues in CDM processes, projects, programs and tools.
- May lead or otherwise oversees the design and implementation of the CDM process with vendors, including data entry, data quality checking, data transfer, reporting, backup and recovery.
- May lead or otherwise oversees the preparation of CRF/eCRF design.
- Ensures completeness, accuracy and consistency of routine clinical data and data structure.
- Acts as a point of contact for study management teams and for Clinical Development regarding data management issues.
- Manages a small CDM team, including responsibilities to hire, develop and retain diverse top talent in the team. Sets clear and elevating goals for the team and individual direct reports. Coaches direct reports on their performance, development and career interests.
- Works collaboratively with other colleagues to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting.
- Identifies, tracks, and resolves CDM queries and issues.
- May serve as lead for one or more studies or projects of increasing complexity, including participating in or leading cross-functional working groups.
- Utilizes reports to track study progress and ensures timeliness and quality expectations are met.
- Leads or otherwise participates in initiatives to gather, organize, and analyze interim clinical data from various data sources.
- Ensures adherence to standard business processes within CDM systems to assure compliance with regulatory requirements.
- Reviews study protocols and assists site coordinators, investigators, and field clinical staff in collecting routine data to meet protocol requirements in a timely manner.
- Provides technical and business process expertise on new and emerging technologies / vendors for clinical trial execution.
- Leads or otherwise participates in the development, review and implementation of continuous improvements, processes, policies, SOPs and other guidance / process documents for CDM.
- Educates study teams and vendors on CDM processes and deliverables, including deviations from established processes.
- Designs and uses all available vehicles for effective scientific communication within and outside Gilead.
- PhD in life sciences or related discipline. PhD with 2+ years’ relevant CDM or other data analytics / data management experience is preferred.
- MA / MS in life sciences or related discipline with 4+ years’ relevant CDM or other data analytics / data management experience.
- Multiple years’ CDM or other data analytics / data management experience, including experience leading small projects and project teams.
- BA / BS in life sciences or related discipline with 6+ years’ relevant CDM or other data analytics / data management experience.
- Strong communication and organizational skills.
- Demonstrates strong facilitation / presentation skills and ability to appropriately delegate tasks to others.
- Has knowledge of CDM or general data analytics and data management best practices and tools and has shown ability to apply this to improve decision-making effectiveness and efficiencies.
- When needed, ability to travel.
- Demonstrated abilities to effectively lead and manage a team of direct reports, either through past effective matrix or direct line management and/or effectiveness coaching and mentoring less experienced colleagues.
- Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
- Demonstrated ability to be a fast learner.
- Demonstrated understanding of how CDM impacts product development goals, including understanding of the implications of data collection and handling decisions with cross-functional stakeholders.
- Demonstrated ability and effectiveness identifying, communicating and escalating project-level issues, such as processes, timelines, resourcing, performance, etc.
- Demonstrated proficiency in leading CDM or related deliverables, including understanding of project timelines and metrics to ensure databases are delivered as needed and in accordance with established timelines.
- Demonstrates advanced knowledge of FDA / EMA regulations, NDA and other regulatory requirements, and web-based EDC and CDM systems, as evidenced by increasing independence in managing CDM or related responsibilities.
- Has strong project and risk management skills, including demonstrated ability to work within budget constraints while using resources efficiently and in a fiscally responsible manner.
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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