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Global Data Management Leader (Oncology)

地点 密西沙加, 安大略, 加拿大 职位 ID R-090512 发布日期 09/16/2020

Regular, full-time

Mississauga, ON

Our data management team supports our global clinical studies from study start-up, to study close-out. The Global Data Management Lead (GDML) works with various study leaders building positive relationships across cross-functional teams to bring data integrity and ensure data quality of AstraZeneca's global late phase studies.

As a core member of the study team, the GDML is responsible for the overall quality and integrity of the clinical database, working positively with global study teams to ensure that AstraZeneca’s Clinical Data is collected, managed, documented and reported clearly, accurately, and securely based on the study’s protocol and to the highest scientific industry standards.

Role Description:

  • Performs data management for all stages of studies including CRF design, DB specifications, crafting and completing the data management plan ((DMP), monitoring initial reviews and query resolution is per agreed timelines
  • Provide oversight and advice to the global study team(s) regarding the CDM activities for studies including audit and regulatory inspections
  • Reviews and resolves issues related to CDM activities by building solutions to complex problems ensuring consistency
  • Provide CDM business expertise and consultancy in the selection and use of software systems and vendors
  • Builds and reviews CDM processes and standards and functional leadership across therapeutic areas, recommending improvements through new insights and aligned to AZ's strategic direction
  • Facilitates and manages valid change requests of project standards to the Standards Committee
  • Management and oversight of vendor performance including providing input into the contract process for the CRDM vendor and billing accuracy and approval
  • Provide guidance and supervision to Lead Data Managers/DM Team Leads supporting studies(CRO or in-house)
  • Responsible for collecting and reporting Adverse Events in accordance with AstraZeneca policies and procedures

Requirements:

  • Education: Minimum of a BS in life sciences or computer science degree
  • Over 3 years of data management experience in the Biotech/Pharma/CRO industry
  • Deep understanding of GCP and regulatory requirements as they relate to data management activities and systems coupled with a current understanding of Good Clinical Data Management Practices (GCDMP)
  • Experience with clinical databases, clinical data management systems and electronic data capture (EDC)
  • Strong communication and interpersonal skills; builds positive relationships with leadership, global colleagues and external partners
  • Ability to work independently under direction and close supervision
  • Excellent written and verbal communication skills
  • Effective organizational, analytical, problem solving and resolution skills
  • High attention to detail and accuracy

Desirable:

  • Certified Clinical Data Manager (CCDM) via the Society of Clinical Data Management
  • Demonstrated knowledge of clinical and pharmaceutical drug development process
  • State of the art understanding of database structures, data standards (CDISC) and practices as they apply to CRF design, database development, data handling and reporting including clinical data system design / development / validation and system interoperability.

Compensation:

AstraZeneca offers regular, full-time employees a flexible health and dental plan that includes a healthcare spending account, a pension plan with additional matching to an employee contribution, access to a group RRSP, free parking, free electric vehicle charging stations, low fee gym membership and a subsidized cafeteria.

Successful candidates for this position will be offered:

Base salary: $100,000 - 120,000

Bonus: 17% (dependent on company and personal performance)

Long term incentive eligibility: up to 15% of base salary

About AstraZeneca

Our purpose is bold and so is our approach. Becoming a more agile and innovative company means creating a vibrant, dynamic culture where we celebrate entrepreneurial thinking and act quickly. We are courageous, taking smart risks and learning from both success and failure. We are curious, creative, and open to new insights and ways of working. Above all, we are passionate about science and driven to always put patients first. Join us and be part of a great place to work; an environment that energizes and empowers each of us to contribute to achieving our goal to develop and deliver life-changing medicines.

Great People want to Work with us! Find out why:

Are you interested in working at AZ? Apply today!



AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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