Senior Clinical Trial Manager

2 weeks ago

Dublin, Dublin City, Ireland Gilead Sciences, Inc. Full time

Senior Clinical Trial Manager page is loaded

Senior Clinical Trial Manager Bewerben locations Ireland - Dublin time type Full time posted on Vor 3 Tagen ausgeschrieben job requisition id R For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

Senior Clinical Trial Manager, Clinical Operations - Dublin

The Position
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 Senior Clinical Trial Manager will be a valued member of the Clinical Operations team in Dublin. The Senior Clinical Trial Manager will work with the Clinical Program Manager to manage global clinical trials or regional components of global clinical trials and/or the entire process of a local clinical trial, with the ability to identify issues and adapt to changes.

Key Responsibilities

• Independently manages global studies and/or regional components of global Phases II-III outsourced studies. Independently manages all components of a small less complex clinical study.

• In partnership with CPMs, provides guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines.

• Responsible for management of the clinical trials budget.

• Experience in developing RFPs and selection and management of CROs/vendors.

• Will serve as the primary point of contact for CROs, addressing questions and applying knowledge to resolve problems.

• Assists in determining the activities to support a project's priorities within a functional area.

• Ability to write study protocols, study reports, sections for Investigator Brochures and regulatory documents with little supervision. Drafts and coordinates review of relevant documents.

• Must be able to understand, interpret and explain protocol requirements to others.

• Coordinates review of data listings and preparation of interim/final Clinical Study Reports.

• In collaboration with data management, develops and participates in review of clinical study data and other metrics to ensure data integrity.

• Responsible for filing necessary documents in the electronic trial master file (TMF), and provide oversight for regular cross-functional reviews of the TMF.

• Provides guidance and training to CROs, vendors, investigators and study coordinators on study requirements.

• May serve as a resource for others within the company for clinical trials management expertise.

• Participate in departmental or interdepartmental strategic initiatives under limited supervision.

• May contribute to development of abstracts, presentations and manuscripts.

• Line management of individuals with oversight from the CPM. Coaches and supports the professional development of a work team.

• May conduct oversight monitoring visits, as required.

• Travel is required.

Knowledge, Experience & Skills:

• BSc or BA in a relevant scientific discipline or RN qualification.

• Relevant clinical trial experience in the pharmaceutical industry.

Gilead Core Values

• Integrity (Doing What's Right)

• Teamwork (Working Together)

• Excellence (Being Your Best)

• Accountability (Taking Personal Responsibility)

• Inclusion (Encouraging Diversity)

About Gilead
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises 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. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

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.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

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