The Biometrics and Data Management (BDM) and eClinical QA Expert provides independent quality consulting, compliance governance and oversight for the end to end clinical data flow and processes starting with the development of study specific electronic data capture tools, and following data management processes including study build, study conduct, study close out, statistical anal-ysis, CSR development and submission to the Health Authorities.
1. Ensures Clinical Data Management processes are in compliance with applicable regulations, guidance, and Novartis Quality Modules and Policies, by facilitating and administering a program of review and approval of the appropriate SOPs and procedures in collaboration with the respective business partners. Plans and evaluates regular quality reviews of eDM documentation across Business Franchises and eDM functional areas as scheduled.
2. Provides quality consultancy and support to Clinical Trial Teams and CQA Franchise Operational QA teams in relation to eClinical related quality breaks and GxP issues.
3. Acts as quality consultant and primary business contact for process improvement initiatives and supports appropriate metrics /measurement approaches in collaboration with affected functional groups.
4. In collaboration with the business partners, develops and implements operational quality improvement strategies resulting in a capable, experienced and empowered global data management organization. This includes but is not limited to business process training, collaboration and communication training and stakeholder management.
5. Ensures the appropriate GxP IT systems are enabling end to end data integrity and are fit for their intended purpose by providing input to user requirements and functional requirements to stay abreast of current and future Novartis internal requirements and external regulatory requirements.
6. Stay abreast of new and changing technologies providing new opportunities to collect and manage a higher volume of patient data such as ePRO systems and direct from patient data capturing devices. Act as quality and compliance consultant to make optimal use of the new e-technology in clinical studies without compromising on the compliance to all applicable regulatory requirements.
7. Plans and evaluates regular quality reviews or assessments of high priority eDM processes, systems and organizations, supports business self-inspection initiatives.
8. Is the lead QA contact for critical, data management and statistics relevant 3rd party service providers and vendors.
9. Acts as subject matter expert for Data Management and Statistics during inspection preparation, inspection conduct and inspection follow up activities, in collaboration with the business partners and CQA peers.
10. Plays an active role in the AQWA incident and change management process, is responsible for the final criticality decision.
This position reports to the Global Head of CQA Data Operations.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Degree in Computer Science or a related discipline.
Experience / Skills:
Minimum 7 years of experience in the pharmaceutical industry, in addition a minimum of 3 years in QA, IT or data management.
A solid understanding of computerized system validation and Part 11 requirements as well as privacy and information security regulations and established good practices with demonstrated GCP expertise,.
Excellent communication, negotiation and influencing skills, be able to lead, influence and coach complex, cross-functional teams.
Project management expertise.
Ability to assess highly complex DM processes and summarizing the essentials in a format understandable for a variety of stakeholders with very different back-ground.
Experience in working with numerous and diverse stake-holders in a complex matrix environment, strong customer orientation
Understanding of latest industry and regulatory trends on e-Clinical Data Management and e-Technology.
Ability to work independently and in a team environment.
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