Location:Gaithersburg, Maryland, United StatesJob reference:
Oct. 26, 2016
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. As a Data Management Quality Leader in Gaithersburg, MD you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. GMD (Global Medicines Development) drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.
AstraZeneca’s vision in Oncology is to help patients by redefining the cancer-treatment paradigm, with the aim of bringing six new cancer medicines to patients between 2013 and 2020. A broad pipeline of next-generation medicines is focused principally on four disease areas - breast, ovarian, lung and hematological cancers. As well as other tumor types, these are being targeted through four key platforms - immunotherapy, the genetic drivers of cancer and resistance, DNA damage repair, and antibody drug conjugates, underpinned by personalized healthcare and biomarker technologies.
In the role as a Data Manager Quality Leader, you will be pivotal in ensuring the data is accurate and complete. Main Duties and Responsibilities
- Serves as the expert in Clinical Research Data Management to provide oversight and advice to the clinical project team(s) regarding the CRDM activities and deliverables
- Manages and resolves issues related to DM deliverables by developing solutions to complex problems to ensure consistency across organization
- Provides input to the CRDM related activities associated with regulatory inspections/audits
- Provide CRDM business expertise and consultancy in the selection and use of software systems and vendors
- Development and oversight of DM processes and standards and functional leadership:
- Oversee quality and consistency with AstraZeneca strategies and standards across therapeutic areas
- Works with the Standards Group to provide input into clinical project standards and processes based on industry best practices
- Facilitates and manages valid change requests of project standards to the Standards Committee
- Assesses AstraZeneca CRDM needs and areas of improvement and recommends changes to the operating model
- May be asked to provide strategic DM expertise to Global Clinical Initiatives
- Management and oversight of vendor contracts, resourcing and budgets
- Reviews, assesses and manages DM delivery against KPIs and overall DM performance
- Provides input into the contract process for the CRDM vendor
- Manages all DM timelines and DM Deliverables for assigned studies
- Ensures DM billing is accurate and forwards recommendation to CDMs/CDaMs for payment of invoices.
- Operational Responsibilities
- Accountable for the execution and overall quality of DM activities and deliverables.
- Acts as the single point of contact for all data management deliverables for the study team during the study set-up phase, responsible for the CRF design, DB specifications (including edit checks, CRF working instructions, etc.), during study conduct, and study close-out activities.
- Provide guidance and supervision to Lead Data Managers working on the study (CRO, Cognizant, or in-house)
- Accountable for “real time” Data Management, ensuring that DM conducts initial reviews within 5 days of a patient’s data entering the EDC system, and manages the average query aging to no more than 20 days.
- Accountable for the overall quality and completeness of the Data Management Plan (DMP).
- Responsible for working closely with the Centralized Data Monitoring (CDM) group to ensure quality and integrity of our most important data points.
- Education: Minimum of a BS in life sciences or computer science degree
- Strong Data Management experience in the Biotech/Pharma/CRO industry (at least 5 years)
- Strong Oncology Therapeutic Expertise (at least 3 years)
Certified Clinical Data Manager (CCDM) via the Society of Clinical Data Management (Preferred)
- Demonstrated knowledge of clinical and pharmaceutical drug development process
- 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)
- 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
- Experience of clinical databases, different clinical data management systems and electronic data capture (EDC)
- Demonstrated understanding of clinical data system design / development / validation and system interoperability.
- Demonstrated leadership (including in an outsourced environment)
- Excellent understanding and demonstration of the AZ values and behaviours
- Demonstrated project management skills
- Strong communication and interpersonal skills
- Excellent organizational and analytical skills
- Ability to work independently
- Demonstrated ability to work effectively with external partners
- Ability to negotiate and influence others across functional areas
- Excellent written and verbal communication skills
- Effective problem and conflict solving skills
- Ability to work in a global team environment
- Ability to interact effectively with all levels of management
High attention to detail and accuracy