Clinical Trial Management Associate
Clinical Trial 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
The Clinical Operations team in Gilead Dublin is a pivotal function of the Paediatric Centre of Excellence in Dublin and is responsible for the management and execution of Paediatric Clinical Trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and other Development Operations functions, Clinical Operations ensures that all clinical trial activities are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of Gilead's products.
The Clinical Trial Management Associate will be a valued member of the Clinical Operations team in Dublin. He/She will work closely with the Clinical Trial Manager as a member of a global or regional study team, to manage components of the clinical trial, with an ability to manage vendors and independently lead part of a study.
- Provides administrative assistance in site selection, study implementation and on-going co-ordination of study sites, either directly or via CROs.
- May monitor or co-monitor study sites to ensure correct study procedures according to Gilead SOPs and protocol procedures, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs and Monitoring plan, as required.
- Under supervision, may assist in review of Protocols, Informed Consents, and Case Report Forms, monitoring plans, abstracts, presentations, manuscripts and Clinical Study Reports.
- Review of trip reports generated by CRO CRAs. May resolve routine monitoring issues.
- May lead a cross-functional team to accomplish study objectives.
- Assists in the management of CROs and Vendors as required.
- Participates in frequent cross-functional review of clinical study data and other metrics to ensure data integrity.
- Assists in preparation of safety, interim and final study reports, including resolving data discrepancies.
- Responsible for filing necessary documents in the electronic trial master file (TMF), and for leading regular cross-functional reviews of the TMF.
- May contribute to SOP development.
- Assists with the preparation and organization of international investigator meetings.
- Performs administrative duties in a timely manner as assigned.
- Tracks and prepares study information using Clinical Operations databases and spreadsheets.
- Travel is required.
Knowledge, Experience & Skills
- BSc or BA in a relevant scientific discipline or RN qualification.
- Minimum one year relevant clinical trial experience in the pharmaceutical industry.
- CRA experience preferred.
- Excellent verbal, written, interpersonal and presentation skills are required.
- Must be familiar with routine medical/scientific terminology.
- Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision as required.
- Must be able to prioritise multiple tasks, plan proactively and accomplish goals using well defined instructions and procedures.
- Knowledge of FDA and/or EMEA Regulations, ICH Guidelines and GCP governing the conduct of clinical trials.
- Working knowledge and experience with Word, PowerPoint and Excel.
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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