Manager, Clinical Data Management
- Job Type
Manager, Clinical Data Management
Ireland - Dublin
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
Specific Education & Experience Requirements:
6 years of experience and a BS degree.
4 years of experience and a MS degree.
3 years of experience and a PhD.
Specific Job Responsibilities:
Works collaboratively with Clinical Programmers, Statistical Programmers, Biostatisticians, Clinical Research, DSPH, Regulatory and Project Management staff to meet project deliverables and timelines for moderately complex clinical data acquisition, quality checking and reporting.
Ensures completeness, correctness and consistency of clinical data and data structure across all projects.
Training and mentoring of CDM staff on business process and clinical programs.
Participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting CDM.
Participate in CDM and cross functional initiative teams.
Project level coordination of CDM tasks, while demonstrating knowledge of hands-on work.
Communication and escalation of project level issues including processes, timelines, resourcing, performance, etc.
Support of regulatory submission activities for assigned project.
Assist with response to questions and findings from Clinical Quality Assurance (CQA) and other audits at the study / vendor level.
Communicates with functional peers regarding project status and issues and ensure project team goals are met.
Participates in the recruiting and hiring process for CDAs and support their professional development.
Provides guidance and training to CROs, vendors, investigators, and study coordinators on study requirements.
Excellent verbal and written communication skills and interpersonal skills are required.
Working knowledge and experience with FDA regulations and familiarity with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA.
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/Ireland---Dublin/Manager--Clinical-Data-Management_R0019507
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