Job Description

Summary

The Pharmacokinetic Sciences (PKS) technical study support team enables efficient management of tactical and operational support for clinical studies at a project and program level. The group is responsible for studies across the globe and would be closely working with a matrix team in enabling regulatory compliance within the target study cycle time. The PK Study Support Associate will build a global center of excellence for managing clinical studies supporting PKS project team members (PTM) thus enabling management of active research projects by the PTMs.

About the Role

Major accountabilities:

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Serve as a single point of contact for global PKS clinical project team members (PTM) for execution or oversight of clinical study support, quality check (QC) and/or non-compartmental analysis (NCA) work of pharmacokinetic data from global clinical studies.

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Connect regularly with global colleagues in maintaining an active list of legacy studies to be covered by the PKS technical study support team

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Build and maintain the team by providing technical and process execution and guidance to enabling successful management of regulatory compliance.

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Execute clinical project support or manage experts to support the clinical project from the global PTM and act as the PKS representative on the study working with the clinical study team (CTT) towards study completion and final clinical study report (CSR).

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Manage the team performance and periodically assess the team members while working closely with line function management to sustain a high-performing team.

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Balance efficiently both the management of a team of experts, as well as individual contributor role with same study management activities performed by rest of the team.

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Key performance indicators:

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Enabling and maintaining business impact through efficient turnaround time for studies while managing key study partners.

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Minimum Requirements:

Work Experience:

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Managing Crises.

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Collaborating across boundaries.

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Project Management.

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Skills:

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Drug Development.

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Employee Recruitment.

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Flexibility.

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Phoenix Winnonlin software

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Teamwork.

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Languages :

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English.

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Why Novartis:

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Benefits and Rewards:

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Division
Biomedical Research
Business Unit
Universal Hierarchy Node
Location
India
Site
Hyderabad (Office)
Company / Legal Entity
IN10 (FCRS = IN010) Novartis Healthcare Private Limited
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No

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 [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.


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