Principal Study Data Manager, Biopharmaceuticals

Job Description

Description

Our data management team supports our global clinical studies from study start-up, to study close-out. The Principle Study Data Manager (PSDM) 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 PSDM 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.

Position: Principal Study Data Manager, Biopharmaceuticals

Type: Regular, Full-Time

Location: Position based in Mississauga, Ontario (Canada)

Role Description:

The Principal Study Data Manager (PSDM) is responsible for coordinating the Clinical Data Management (CDM) deliverables on assigned clinical studies and act as an expert on CDM processes, standards and technology. The PSDM is a member of the Global Study Team (GST) and the main point of contact for the Data Management(DM) vendor. The PDM ensures CDM deliverables follow standards and meet data quality while maintaining business continuity for CDM processes and standards including integrity of the clinical database for the relevant studies.

Accountabilities:

  • Coordinate the Clinical Data management deliverables on assigned studies depending on the relevant model and DM Vendor. Takes accountability and serves as the first line of contact at the study level.
  • Demonstrates leadership and operational knowledge in the planning and delivery of CDM deliverables at a study level potentially under mentorship from a Principle Clinical Project Data Manager.
  • Communicates and collaborates effectively with all study level team members. Primary point of contact for DM vendor and provides guidance and supervision to Lead Data Manager/DM Team Lead working on the study (CRO or in-house).
  • Oversight of the day to day operational aspects of CDM for assigned studies; Responsible to identify risks and collaborate with the DM Vendor to mitigate the risk.
  • Understands therapeutic area, indication or program specific data capture standards and AZ standards.
  • Provide input into CDM related activities associated with regulatory inspections/audits for assigned studies.
  • May provide input to the selection and use of software systems, devices and vendors.
  • Responsible for compliance to Trial Master File requirements relating to DM Vendor
  • Support Senior Leaders to oversee CDM Vendor performance, depending on relevant model. Review, assess and manage DM Vendor delivery against KPIs, budget and overall performance. Oversees vendor timelines and milestone deliverables for the assigned studies. Ensures DM Vendor billing is accurate and gives recommendations for payment of invoices.
  • Drive adherence to AZ CDM standards and processes for data quality and consistency of data capturing for assigned studies.
  • Maintain an awareness of the external and internal models in order to participate in change initiatives and continuous improvement activities related to CDM operating models.
  • Demonstrates willingness to take on ad hoc activities consistent with current or experience in support of CDM.
  • Mentoring junior Clinical Data management colleagues

Requirements:

  • Education: Minimum of a BS in life sciences or related subject, pharmacy nursing or equivalent degree
  • Strong Data Management experience in the Biotech/Pharma/CRO industry
  • Demonstrated current understanding of GCP and regulatory requirements as they relate to data management systems and activities
  • Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP)
  • Experience of clinical databases, different clinical data management systems and electronic data capture (EDC)
  • Demonstrate understanding and experience in query management process and reconciliation activities
  • Strong communication and interpersonal skills
  • Ability to work independently without close supervision
  • Excellent written and verbal communication skills
  • Effective problem and conflict solving skills
  • Ability to work in a global team environment
  • 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
  • Knowledge of SQL, 4GL, VBA or R software
  • Demonstrated understanding of clinical data system design / development / validation and system interoperability.
  • Excellent understanding and demonstration of the AZ values and behaviours
  • Demonstrated professioalism, dipomacy, mutual respect and ability to manage and value diversity and cultural differences while promoting productivity through encouragement
  • Excellent organizational and analytical skills
  • Demonstrated ability to work effectively with external partners
  • Ability to interact effectively with all levels of management

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.

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Are you interested in working at AZ? Apply today!

   

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