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Post : Expert Data Clinical Standards Specialist
Job Description
The Expert Clinical Data Standards Specialist is responsible for the planning, development, maintenance, training and support of end-to-end data and reporting standards supporting efficient and high quality collection, reporting and regulatory submission of clinical trial data across the Novartis Global Drug Development portfolio compliant with regulatory and industry standards. Using strong project management and technical skills, they drive the development, implementation and governance of one or more disciplines of harmonized data and reporting standards including data acquisition and tabulation, analysis and reporting and/or regulatory submission across multiple disease/therapeutic areas and drug development phases enabling efficient business processes and operational agility across GDO Data Operations activities.
Major Activities:
1.Responsible for leading all aspects of clinical data and reporting standards definition, development and support within assigned standards discipline and area including the planning and development and maintenance of associated metadata, documents and guidelines where applicable.
2.Define and deliver to robust, priority driven standards development plans for assigned area to ensure agreed deliverables are met and assigned resources are fully and effectively utilized.
3.Accountable for the effectiveness, quality, compliance and timeliness of assigned activities and deliverables.
4.In collaboration with representatives across Data Operations disciplines and key stakeholder and partner functions within GDO and across Global Drug Development, independently lead discussions supporting global and/or disease/therapeutic area standards development, implementation and governance with a focus on scientific and analytical goals and needs.
5.Liaise with governance boards, internal scientific committees and other relevant bodies to ensure the accurate translation of scientific and analytical requirements into efficient, compliant standards, guidelines, policies, business rules and training materials.
6.Lead/contribute to the technical review and assessment of industry and regulatory standards and guidelines performing regular gap/impact analysis defining and implementing action plans where needed.
7.Assume the role of lead subject matter expert (SME) for assigned area providing expert support, technical guidance and training to end users and SME networks on implementation of standards and related tools on clinical trials and development programs.
8.Act as an expert Clinical Standards representative leading/contributing to data standards governance, process improvement initiatives and/or other non-clinical projects.
9.Lead and/or support the development, testing and validation of tools, process and systems supporting the Company Clinical Standards framework.
10.Maintain up-to-date, expert knowledge of relevant technologies (EDC, software languages, applications etc.), Industry Standards (e.g. CDISC, define.xml, eCTD etc.) and regulatory guidelines.
11.Represent Novartis within industry wide associations and working groups; lead, influence, collaborate and proactively shaping the external environment including regulatory guidelines, industry practices and professional standards development organizations such as CDISC, CFAST, PhUSE CSS, DIA etc.
Candidate Profile
Education:
BA/BS/MS or equivalent experience in health sciences, statistics, computer science or related field.
Experience/Professional requirement:
1.At least 7 years industry experience in global drug development within the pharmaceutical industry.
2.Expert knowledge in one or more area of industry data standards and requirements including data acquisition, CDISC (CDASH, SDTM, ADaM), reporting and analysis, regulatory data submission.
3.Proven experience in supporting development of clinical standards and associated guidelines.
4.Strong knowledge of database design, data structures and/or basic statistics and reporting.
5.Proven experience leading/working in highly matrix teams and providing technical guidance and training.
6.Strong project management and coordination skills.
7.Proven experience reviewing/assessing industry and regulatory standards and guidelines.
8.Strong understanding of drug development, global clinical trial / project practices, procedures, methodologies.
9.Excellent understanding of regulatory requirements and industry standards relevant to data management and statistical programming (including GCP, ICH)
10.Proven experience supporting non-clinical projects/initiatives.
11.Excellent interpersonal and communication skills.
12.Outstanding verbal and written skills.
Additional Information:
Experience: 7 years
Location: Hyderabad
Education: BA/BS/MS
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Research & Development
Job ID: 220464BR
End Date: 8th Sept., 2017
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