Clinical Trials Manager - Oncology

Melbourne University
See job description.
February 22 2021
Life Sciences, Oncology
Position Type
Full Time
Organization Type
Job Type

Clinical Trials Manager - Oncology
Australia - Melbourne

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

Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercialises innovative medicines in areas of unmet medical need. Our heritage of science and innovation and the curiosity and passion of everyone who works here has enabled us to provide medicines that help transform standards of care for more than 30 years. Gilead's therapeutic areas of focus include liver diseases, infectious diseases, inflammatory diseases and cancer.

Clinical Operations is responsible for the execution of all Phase 1-4 clinical trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and Development Operations functions, ensures that all clinical trial activities are performed in accordance with all 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.

This Clinical Trials Manager position will support primarily phase 2 & 3 studies with key focus on Gilead's upcoming Oncology space and provide oversight from feasibility through to close out, reporting to the Clinical Program Manager.

Role Responsibilities:
  • Serve as external scientific expert in the therapy area, healthcare landscape, and data on Gilead and competitor medicines
  • Drafts and/or coordinates review of relevant documents including but not limited to protocols, informed consents, case report forms, monitoring plans, investigator brochures and clinical study reports
  • Must be able to understand, interpret and explain protocol requirements to others
  • Maintains study timelines
  • Coordinates review of data listings and preparation of interim/final clinical study reports
  • Assists in determining the activities to support a project's priorities within functional area
  • Contributes to development of RFPs and participates in selection of CROs/vendors
  • May be asked to train CROs, vendors, investigators and study coordinators on study requirements
  • Quality oversight visits for outsourced studies
  • May serve as a resource for others within the company for clinical trials management expertise
  • Able to examine functional issues from an organizational perspective
  • Participates in the recruiting and hiring process for CPAs and CTMAs and support their professional development
  • May contribute to development of abstracts, presentations and manuscripts
  • Under supervision, may design scientific communications within the company
  • Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision
  • Must have a general, functional expertise to support SOP development and implementation
  • Excellent teamwork, communication, decision-making and organizational skills are required
  • Thorough knowledge of local Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies
  • Working knowledge and experience with Word, PowerPoint and Excel
  • Travel is required for this position

Project Involvement:
  • Manages geographical region (APAC) of a large complex clinical trial
  • Independently manages all components of a small less complex study
  • Primarily supports Phase 2-3 study execution
  • Manages cross functional timelines
  • Quality oversight responsibilities for outsourced studies
  • Collaborates with local Regulatory Affairs and Global Patient Safety on all development studies
  • Collaborates with local medical affairs colleagues on country specific studies and initiatives
  • Provides knowledge and expertise on country specific regulations, site experience and suitability for development studies

  • Manages vendors
  • Task management may be required
  • Mentors junior team members

Required Knowledge, Experience & Skills:
  • At least 5+ years of experience and a BS or BA in a relevant scientific discipline
  • Study start-up, site monitoring and project management experience ideally Oncology/Hematology experience preferred
  • Advanced project management skills adequate to manage the entire process of a clinical trial
  • Ability to prioritise and identify critical path
  • Ability to identify issues and adapt to changes
  • Ability to lead cross-functional teams internally and externally
  • Mentors team members
  • Ability to work independently with minimal oversight
  • Will incorporate study logistics and planning to accomplish study objectives

Being here matters.

At Gilead we are committed, hardworking and passionate about improving the lives of the patients who use our products. Our values - integrity, inclusion, teamwork, accountability and excellence - are evident in everything we do. We are a close-knit team where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development.

We want all our employees to embrace and leverage each other's talents and diverse perspectives, foster a sense of belonging, achieve their full career potential and contribute to the team's success. This is demonstrated through our Silver Status in the Australian Workplace Equity Index.

As an equal opportunity employer, Gilead Sciences is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.

For Current Gilead Employees and Contractors:

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