Senior Clinical Data Management Associate
Senior Clinical Data Management Associate
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
- Works collaboratively with Programming (Clinical and Statistical), Clinical Operations, Biostatistics and others such as Clinical Research, Global Patient Safety, Regulatory and Project Management staffs to meet project deliverables and timelines for non routine clinical data acquisition, quality checking and reporting.
- Ensures completeness, accuracy and consistency of clinical data and data structure.
- Ensures adherence to standard business processes within CDM systems to ensure compliance to regulatory bodies.
- May lead in the design and implementation of clinical data management process with vendors including data entry, data quality checking, data transfer and reporting.
- Leads the preparation and design of CRF/eCRFs.
- Reviews study protocols and assist in the planning and implementation of the data management portions of clinical studies.
- Interact with site coordinators, investigators, and field clinical staff in collecting data and resolving queries to meet the protocol requirements in a timely manner.
- Utilizes reports to track study progress and ensure timeliness and quality expectations are met.
- Excellent verbal and written communication skills and interpersonal skills are required.
- The ability to problem solve. Exceptional people/project leadership skills are required.
- General knowledge of FDA/EMA regulations and with webbased Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA is also required.
- Capable of handling studies that are complex in scope and volume.
- Effectively interacts with vendors to communicate expectations for study timelines and milestones.
- May lead the design and implementation of the clinical data management process with vendors including data entry, data quality checking, data transfer, reporting, backup, and recovery.
- Demonstrates ability to appropriately delegate tasks to CDMA I and CDMA II staff members.
- Provide technical and business process input/expertise on new and emerging technologies/vendors for clinical trial execution.
- Demonstrates strong facilitation/ presentation skills.
- May act as a mentor to junior employees.
Typical Education and Experience
- Relevant years of experience and a BS degree.
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:
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