Clinical Trials Operations jobs "A"

 Responsible for Supporting all Operational Aspects of Clinical Trial

Novartis Healthcare Pvt. Ltd.

2 - 7 yrs

Hyderabad / Secunderabad

Job Description

Responsible for supporting all operational aspects of clinical trial(s) (phase II through lifecycle management) under the leadership of the Global Trial Leader (GTL). Assist program level activities under the direction of the Clinical Scientist (CS).1. Support GTL in ensuring all operational trial deliverables are met according to timelines, budget, procedures and quality standards, development of study tools, guidelines and training materials; management of clinical study material, implementation of issue resolution plan. 2. Support GTL in preparation of clinical outsourcing specifications and in the follow up with day to day operation with vendors. 3. Support the development, management and tracking of trial budget working closely with the GTL and FinOM. 4. Support CS in the preparation of training materials and presentations related to the planning and conduct of the trial. 5. Support GTL in the management of the trial master file. 6. Support GTL in managing interactions with the clinical trial team and CPOs. 7. Support GTL in management of trial allocation and coordination of activities leading to site initiation. 8. Support Medical Lead/ CS/ GTL by generating data cleaning reports and reviewing non medical data as assigned. 9. Support the GTL in trial close out activities. 10. Draft CTT meeting minutes. Participate in clinical trial team meetings. 11. May organize and chair trial sub-teams within the scope of his/ her delegated responsibilities. 12. Assist CS/ Medical Lead with program level activities (i.e., DSUR, PSUR, IND updates, coordination of Advisory Boards), and support the implementation and management of trialmonitoring boards (i.e., Adjudication Committees and Data Monitoring Committees) as assigned. 13. Responsible for implementation of best practices within Global Clinical Operations. 14. Participate in the on-boarding, mentoring and training of new staff.- Efficient, quality-driven, timely execution of global clinical trials in compliance with international and local regulations and Novartis internal standards; - Timely submission and delivery of high quality clinical trial documents to achieve critical milestones.

Company Profile:

Novartis Healthcare Pvt. Ltd.

A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes us one of the most rewarding employers in our field.

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