Job Description

Band

Level 4

Job Description Summary

-Contributes with appropriate oversight to all relevant aspects of global clinical trial(s) activities to deliver study outcomes within schedule budget quality/compliance and performance standards. May lead specific aspects of global clinical trial(s). Core member of the Clinical Trial Team Contributes to operational excellence through process improvement and knowledge sharing and/or provide inputs to clinical development process. -Applicable to Clinical Scientific Expert IIThe Clinical Scientific Expert II (CSE II) provides clinical and scientific support through all phases of a clinical study under the guidance of the (A)CD(M)D in compliance with Novartis processes ICH GCP and regulatory requirements. This role applies the principles of clinical data review excellence and identifies clinical data insights to ensure data is scientifically plausible and to identify trends signals and risks associated to trial endpoints and patient safety. The CSE II is a core member of the Clinical Trial Team (CTT). In addition the CSE II supports/leads program level documents or activities as assigned.

Job Description

This is a newly created position regarding the establishment of a clinical translational research hub.
本募集はClinical Translational Research Hub設置に関して新設されるポジションです

Major accountabilities:

• Contributes to all operational/clinical trial deliverables that are in scope of the specific JD according to timelines budget operational procedures quality /compliance and performance standards.
• Conduct/Contribute to study start-up activities such as overseeing protocol development CRF development Informed Consent Form development.
• Ensuring proper handling of all study conduct and close out activities including but not limited to site close out final drug accountability and audit readiness of Trial Master File documentation (if in scope of the specific JD).
• Responsible for education implementation and compliance to standards (SOPs) and best practices for clinical operations/clinical data review activities within assigned clinical trial(s) and within clinical program(s) including sharing lessons learned.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Key performance indicators:

• Timely efficient and quality execution of assigned trials and trial related activities within budget and in compliance with quality standards.
• Proactive operational planning with effective contingency and risk mitigation plans.
• Adherence to Novartis policy and guidelines and external regulations -Applicable for Clincial Scientific Expert II: -Performing clinical data review and insights consistently and accurately which meets the Novartis quality standards timelines and is inspection ready.
• High quality contributions to study/ program level and/or submission documents (e.g. IDP protocol ICF clinical sections of CTA).
• Strong leadership skills to be able to support management in team competency building lead/contribute to local/global initiatives and best practice sharing across programs and/or departments -Clearly demonstrates Novartis Values and Behaviors (i.e. Innovation Quality Collaboration Performance Courage and Integrity.

Minimum Requirements:
Work Experience:

• Financial Management.
• Collaborating across boundaries.
• Operations Management and Execution.
• Project Management.

Skills:

• Budget Management.
• Clinical Research.
• Clinical Trial Protocol.
• Clinical Trials.
• Coaching.
• Data Analysis.
• Data Integrity.
• Learning Design.
• Lifesciences.
• Risk Monitoring.
• Trends Analysis.

Languages :

• English.

Program/Project Responsibility

Leader and/or Clinical Scientist for predominantly low complexity global studies and may provide additional Clinical Sciences support to high complexity global studies.
or support the clinical protocol development process incollaboration with the Medical Lead and other line functions; responsible author for clinical protocols amendments etc.; contribute to the medical/scientific input given for the development of study-related documents and processes which resides in other line functions; contribute to the development of clinical sections of study-level regulatory documents.
development of strategic and scientific input into study concept feasibility and ability to execute; develops and implements study-level operational execution plan in partnership with key cross functional partners if applicable.

with key cross functional partners to identify and select strategic and high performing sites to ensure recruitment commitments are met.
or support a global cross functional CTT to ensure all trial deliverables are met; sets stretch goals promotes realistic planning and timelines and presents actionable alternatives to accelerate timelines.
with line functions to gain input and alignment and manages internal and external stakeholder expectations.
or support the ongoing medical/scientific review of clinical trial data across assigned studies in collaboration with the medical expert and key line functions and partners on data analysis and data interpretation including safety trend analysis signal detection development of first interpretable results reporting clinical study results in CSR and internal/external publications.
lead or support dose escalation meetings with the real time availability of quality clinical trial data toprovide consolidated information for dose escalation meetings andPhase II data reviews with relevant stakeholders.
lead or support risk mitigation discussions riskmanagement and implementation at the trial level.
and accountable for forecasting and managing overallstudy budget(s) in collaboration with key partners.
with key partners to set vendor strategy and timelines forassigned studies.
for implementation of best practices and standards fortrial management including sharing lessons learned. Represent Groupon initiatives; may serve as Subject Matter Expert.
to talent and career development of collaboration with the relevant manager contributes to hiring/interview/onboarding and mentoring process for new hires.

For associates based in China and Japan develop local early development strategy lead local study activities throughout the study lifecycle may serve as a regional BR liaison for scientific research activities if required.

Impact on the Organization

Responsible for the availability of high quality Biomedical Research data according to agreed timelines and budget to enable no delays in strategic decision making and drug registration. External impact: Novartis perceived as a credible ethical and preferred business partner.

Minimum Requirements/Skills

Bachelors in life science/healthcare required; Advanced degree or equivalent education/degree in life sciences/ healthcare preferred (PhD/MD/PharmD/ Masters).
Approximately 2 years experience in clinical trials/development
For TCO: Strong understanding of oncology/hematology and demonstrates high learning agility.
For TM: Demonstrates high learning agility.
Demonstrated ability to drive collaborations through unpredictable circumstances and higher paced changes.
Demonstrates tolerance for ambiguity willingness to adapt and willingness to speak-up and challenge.
Proficient in clinical trial methodology with an emphasis in early clinical development. Operational project management experience including excellent planning prioritization problem solving and organizational skills.
Track record of successfully managing multiple clinical trials concurrently. Used to managing multiple priorities.
Demonstrated capability to interpret discuss and represent trial level data.
Working knowledge of clinical finance principles to manage efficient expenditure to minimize variance between actual and forecasted spend.
Maintain good knowledge of ICH-GCP external regulations and procedures and supplements by training and practice of Novartis SOPs and internal policies.

Language:

Fluent Japanese and English (oral and written)

Benefits and Rewards:

You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.

Commitment to Diversity and Inclusion

Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve.

Accessibility and accommodation

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the recruitment process or in order to perform the essential functions of a position please send an e-mail to and let us know the nature of your request and your contact information. Please include the job requisition number in your message .

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Skills Desired

Budget Management Clinical Research Clinical Trial Protocol Clinical Trials Coaching Data Analysis Data Integrity Learning Design Lifesciences Risk Monitoring Trends Analysis

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