Clinical Project Associate

**Summary**:

- Support QC/completeness checks on all global TCO study TMFs in accordance with Novartis SOPs, working practices and ICH/GCP Guidelines. Follow-up with the CTT to resolve quality issues identified and escalate potential SOP/WP deviations.. - Maintain up to date knowledge of the TMF Reference Model. Support documentation of appropriate oversight and tracking of TMF QC activities.

**About the Role**:
Your responsibilities include, but are not limited to:

- Support QC/completeness checks on all global TCO study TMFs in accordance with Novartis SOPs, working practices and ICH/GCP Guidelines. Follow-up with the CTT to resolve quality issues identified and escalate potential SOP/WP deviations..
- Maintain up to date knowledge of the TMF Reference Model. Support documentation of appropriate oversight and tracking of TMF QC activities.
- Execute trial TMF QC activities in accordance with TCO portfolio and Clinical Operations Transition Decision Point (TDP) and Clinical Study Report (CSR) dates. Support CTTs with audit/inspection prep activities.
- Track TMF key quality indicators (KQIs) and overall compliance to the TMF processes and regulations. Provide training to the CTTs on TMF processes and QC measures.
- Participate in CTT and TMF Ops Service meetings supporting resolution and close out of TMF review findings. Serve as SuperUser (SU) on document management systems (e.g. CREDI, Subway, Novartis Clinical Vault (NCV)).
- Serve as a SuperUser for ARONDA, the archival document management system, supporting teams with retrievals of documents on request. Participate and/or lead meetings related to TMF processes and trainings (e.g., Clinical Compliance Forum meetings)
- Participate in the on-boarding and training of new ClinOps staff as related to document management process in TCO.
- May serve as TCO representative on TMF process improvement initiatives, committees, work streams and governances. May perform Clinical Project Associate (CPA) tasks as assigned

Commitment to Diversity & Inclusion:

- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
- A minimum of 1 year experience in the Pharmaceutical Industry with knowledge and experience in quality management reviews of the Trial Master File, preferred.
- Ability to work effectively on either self-managed projects or as a team member.
- Ability to adjust to multiple demands, shifting priorities, and unexpected events in a fast-paces environment while maintaining a positive work attitude.
- Self-motivated with a high degree of ownership and accountability for results.
- Developed or have participated in the development of guidance documents, work practices and tracking tools.
- Provided training and mentorship to a colleague on a 1:1 basis or in a meeting setting.
- Bachelor’s degree or equivalent education/degree qualification in life science/healthcare required.

WHY NOVARTIS
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying Imagine what you could do here at Novartis
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

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

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