Clinical Development Physician at Novartis

Shanghai, Shanghai, China -

Full Time

Start Date

Immediate

Expiry Date

21 Jun, 26

Salary

0.0

Posted On

23 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Monitoring, Clinical Research, Clinical Trial Protocol, Clinical Trials, Decision Making Skills, Drug Development, Health Sciences, Lifesciences, Regulatory Compliance, Managing Crises, Functional Breadth, Collaborating Across Boundaries

Industry

Pharmaceutical Manufacturing

Description

Band Level 4 Job Description Summary -Oversees the execution, and interpretation of clinical trials research, data collection activities and clinical operations. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. Support new and ongoing clinical research and clinical trials and ensure efficient and timely processing of confidentiality agreements and clinical agreements. Monitors adherence to protocols and determines study completion. Manages clinical and regulatory files and maintains clinical inventory intended for distribution to investigational sites. May interact with investigational sites, clinical consultants, Contract Research Organizations and other vendors. Selects, develops and evaluates personnel to ensure the efficient operation of the function. Job Description Major accountabilities: Oversees clinical program(s) across indications, executing medical strategy for development and marketed products in a defined therapeutic area. Is responsible for assuring aligned communication with Country/Cluster Clinical Research Associates, Managers and other key stakeholders on the execution and progress of the clinical studies. Identify new sites for clinical trials; analyze capability and make recommenda-tion for trial inclusion. Facilitate preparation and collection of site level documents; resolve problems as required. May execute site initiation and training. Implement total site management including monitoring visits, regulatory assess-ment, drug supply management and resolution of site problems to ensure compli-ance. Track trial execution milestones; identify problems; resolve issues and escalate as appropriate. May manage recruitment and execute contingency plans, as needed. Complete preparation/generation of study monitoring reports. May lead and chair local study team meetings, attend and participate in global clinical trial team meetings -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: Deliver customer satisfaction results for internal and external customers -Delivery of Clinical Trials to quality standards and agreed timelines -Adherence to Novartis policy and guidelines and external regulations. Minimum Requirements: Work Experience: Managing Crises. Functional Breadth. Collaborating across boundaries. Skills: Clinical Monitoring. Clinical Research. Clinical Trial Protocol. Clinical Trials. Decision Making Skills. Drug Development. Health Sciences. Lifesciences. Regulatory Compliance. Languages : English. Skills Desired Clinical Research, Clinical Trial Protocols, Clinical Trials, Clinical Trials Monitoring, Decision Making, Drug Development, Health Sciences, Life Science, Regulatory Compliance Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives. Novartis is aware of employment scams which make false use of our company name or leader’s names or recruiter’s names to defraud job seekers. Novartis does not make job offers without interview and never asks candidates for money. If you have encountered a job posting or been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond, send money or personal information. In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov .

Responsibilities

This role oversees the execution and interpretation of clinical trials research, data collection, and clinical operations, establishing scientific methods for protocol design and implementation. The incumbent is responsible for assuring aligned communication regarding clinical study progress and managing site-level activities including initiation, monitoring, and problem resolution.