Clinical Project Associate

14 hours ago

Hyderabad Telangana, India Novartis Full time

**Summary**:
Support Study Lead in TCO studies in ensuring all trial deliverables are met according to timelines, budget, operational procedures and quality standards.

**About the Role**:
Support TCO CSD, CSaD, and CSTL in ensuring all trial deliverables are met according to timelines, budget, operational procedures and quality standards. Assigned responsibilities can include development of specific sections of selected study documents development of study tools, guidelines, and training materials; management of clinical study material; and implementation of issue resolution plans.
Under the supervision of the CSD, CSaD and CSTL, key contributor for preparation of CSR appendices.
Support CSD, CSaD and CSTL by setting up and maintaining appropriate study tracking forms including:
Enrollment log/trial allocations forms, site and vendor contact lists, drug shipping logs, set up and maintenance of team membership and contact lists.
Support CSD, CSaD and CSTL in managing interactions with relevant functions including Global Clinical Supply and Novartis country organizations.
Support CSD, CSaD and CSTL in all drug tracking (central hubs, local CPOs and sites) to ensure adequate supply, monitor expiry dates and assist in relabeling as appropriate. Support CSD, CSaD and CSTL in tracking all batch numbers used throughout trials.
Provide support to CSD, CSaD and CSTL in the creation and maintenance of HQ TOC and ensure timely completion and maintenance of TMF in the relevant DMS.
Support CSD, CSaD and CSTL in delegated aspects of trial data analysis and reporting, including attendance at all relevant study meetings (i.e. CTT and dose escalation meetings). Provide support in meeting scheduling and distribution of meeting agendas/minutes.
Assist CSD, CSaD and CSTL with preparation, distribution and archiving of study tools needed at study start up and throughout trial as appropriate.
Support the CSD, CSaD and CSTLs for both PK and biomarker sample tracking in collaboration with the CTT and act as a liaison with sites for kits and sample shipment, sample reconciliation and associated logistics.

Support financial management and forecasting within scope of assigned authority
Support the CSD, CSaD and CSTLs in vendor management activities, including coordinating shipment and returns of ECG machines.
May support selected tasks for other ClinOps functions including but not limited to, Disease Area Leads/Platform Areal Leads, EDO Lead/VPSD, Translational Clinical Biomarker and TCO Clinical Compliance group.

Division

Biomedical Research

Business Unit

Pharma Research

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

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