Senior Manager, GLPS Operations Clinical Trial Support
Senior Manager, GLPS Operations Clinical Trial Support
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 mission in the Operations group supports the Global Patient Safety (GLPS) mission to protect patients and ensure Gilead is compliant with global safety regulations via the following:
Support of PVE functions on technical issues, systems and process improvement initiatives, Argus database, REMS and pharmacovigilance systems
Management of ICSRs and submission of Suspected Unexpected Serious Reactions to investigators/ethics committees, and aggregate reports to applicable ethics committees
Support for Gilead clinical studies including review of study protocols, development of Serious Adverse Event (SAE) process flows and reconciliations and provision of training material for contract research organizations (CROs) and investigators
This position will primarily focus on the clinical trial support for studies based both in the local office as well as the potential of international based studies. This includes managing form the GLPS a number of study managent teams, reconciliaiton, etc.
Must be able to facilitate effective interactions within the Pharmacovigilance & Epidemiology Department, as well as with other departments within the company (Clinical departments, Medical Affairs, Epidemiology, Regulatory, Biometrics, Legal, QA, IT, Commercial operations), and Gilead affiliates/partners.
Defines GLPS project team strategy and manages or leads functional and cross-functional projects as a key representative of PVE Operations management team
Oversees activities associated with clinical trial management, clinical trial conventions, and/or clinical trial submissions activities.
Contributes to development of standardized clinical trial practices, procedures, metrics and measures productivity and performance of PVE Operations.
Ensure study management team leads are in compliance with all clinical trial reporting requirements to partners and regulators.
Collaborates with all GLPS functional groups to ensure compliance with regulations and GLPS standards to ensure that GLPS is compliant with all current regulations pertaining to clinical trial product safety as well as company policies.
Serves as consultant to GLPS management in area of clinical trial conventions and expertise and acts as a spokesperson for the GLPS organization in matters pertaining to its policies, plans, and long-term strategic trial objective
Knowledge and experience with clinical trial safety reporting and regulatory compliance and experience with international safety reporting/regulations is a must
Identifies best practices for continuous improvement of case quality, compliance, and process improvements.
Experience with participation in GCP audits
Utilizes strong operational management skills to ensure team is achieving the strategic business goals of GLPS
Demonstrates the ability to handle increasing responsibilities as scope of responsibilities may change (team growth, integration efforts across other department organizations)
Effectively represents PVE on multidisciplinary teams; ability to evaluate and analyze procedural gaps.
Partners with Clinical Operations Study leads to ensure alignment of process handoffs between the clinical and GLPS teams, including oversight of GLPS work performed by Clinical CROs.
Able to gather information of assigned tasks or activities for one of more projects
Works independently, establishing work priorities and direction with minimal input.
Knowledge, Experience & Skills
- Excellent oral and written English communications skills.
- Ability to work both within the group and across groups.
- Demonstrated effectiveness in cooperation and teamwork skills.
- Judgment/problem solving skills.
- Analytical and assessment skills.
- Planning and information seeking skills.
- Attention to detail.
- Ability to understand and effectively relate to external and internal customers.
- Good working knowledge of computer technology.
- Relevant drug safety, drug development, or clinical trial experience.
- Previous people management skills required for people management responsibilities
- An in-depth knowledge and thorough understanding of FDA, EU and global regulations, ICH guidelines, and GCPs that govern drug safety and pharmacovigilance.
- Degree in biological sciences, nursing, pharmacy or medicine preferred.
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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