About the role

Aplyr's Quick Take

This role is focused on supporting clinical studies related to biomarkers and pharmacokinetics. You'll coordinate sample logistics, manage vendor relationships, and ensure smooth operations throughout the study lifecycle. It's an individual contributor role that requires collaboration with various teams.

Good fit

Ideal candidates have a background in life sciences or a related field, with several years of experience in clinical trial operations or biomarker research. A detail-oriented and proactive working style will help you thrive in this environment.

Worth noting

The position is office-based in Hyderabad, which may be a consideration for those looking for remote work options. The role involves significant interaction with external vendors and clinical sites, which can be a challenge if you're not comfortable with external communication.

Job Description Summary

Laboratory Excellence and Operation (LEO) and Biomarker Science and Operation (BSO) team in India are the key global resources for Line functions Laboratory Excellence and Operation (LEO) and Biomarker Science and Op-eration (BSO) team in India are the key global resources for Line functions (LF) and Translational Medicine (TM) Clinical Trial Teams for biomarkers including biomarker outsourcing, scientific biomarker monitoring, vendor management, biomarker logistics, clinical site communication and sample coordination. LEO/BSO are working in close collaboration with clinical teams, LF technology experts, Biomarker Leads (BMLs) as well as external service providers (ESP) including central labs and clinical sites

Job Description

Key Accountabilities

Provide operational support to clinical studies focused on biomarkers, safe-ty and PK samples, including clinical study setup, sample tracking/reconciliation, assay and vendor coordination, sample/data upload support and study closure activities. Responsibilities include supporting the re-view of clinical study protocols, site operations manuals, informed consent forms, sample collection tables, instruction manuals, central lab proto-col/manual, eCRF-related content, and other biomarker sample operation logistics.
Serve as a BMD Study Coordinator/ and clinical team representative from BMD on selected clinical studies and/or at a project level.
Partner with clinical teams, data management, central labs, vendors, and internal functions to support biomarker and PK sample related activi-ties.Independently set up central lab and central lab services (specifications, clinical sites, samples, assays),
Implement and monitor biomarker/PK sample flow across BM modalities (e.g., Immunoassay, LC-MS, Flow cytometry, genetics etc.) and PK assays
Maintain and update study and project information in relevant reports, trackers, dashboards, and IT systems.
Identify and escalate sample management, assay, vendor, data, quality or performance-related issues and to senior team members, subject matter experts, clinical trial leaders, and data management teams as appropriate.
Contribute to process improvements, best practices, process and continuous improvement initiatives within sample, vendor, data and assay monitoring activities.
Collaborate across Translational Medicine functions, central lab, clinical sites, and vendors to support efficient study execution, aligning with defined LEO processes.

Essential Requirement

Master’s degree (M.Sc.) in Life Sciences or advanced degree in Clinical Operations, Clinical Bioanalysis, Biomarkers, or related field, with ~3+ years of relevant clinical operations experience.
Operational knowledge of clinical trials: clinical study set up, central lab set up, clinical sample management, clinical data flows (e.g. DTS) clinical sample analysis and managing external service provider (ESP) including central laboratories and/or specialized vendors
Knowledge of the drug development process, clinical biomarkers, clinical data management and working with translation clinical research is a plus
Strong global project management, proactive planning in clinical studies, problem solving, influencing, and communication skills.
Knowledge of regulatory requirements e.g. ICH/GCP, GLP, etc

Desirable Requirement

Laboratory background, knowledge of bioanalysis, are desired.
Experience working in a global organization and matrix environment (multiple roles/connections and stakeholders) is a plus.

Skills Desired

Biomarkers, Clinical Trials, Communication, Data Transfers, Global Project Management, Influencing Skills, Stakeholder Relationship Management

Aplyr's read

Novartis is a Swiss-based global healthcare leader, known for its focus on innovative medicines and commitment to addressing patient needs through diverse roles.
Synthesized from recent postings & public sources

What's promising

•Novartis invests heavily in research and development, driving innovation in pharmaceuticals.
•The company offers a wide range of global career opportunities across various fields.
•Strong focus on cutting-edge therapies, including gene therapy and AI-driven solutions.

What to watch

•Regulatory challenges can impact the speed of drug approval and market entry.
•High competition in the pharmaceutical industry requires constant innovation to maintain market position.
•Complex organizational structure may slow decision-making processes.

Why Novartis

•Novartis has a robust pipeline of innovative medicines, setting it apart in the healthcare sector.
•The company emphasizes a diverse and inclusive workplace culture across its global operations.
•Novartis is a leader in digital transformation within pharmaceuticals, integrating AI and data science.

Aplyr’s read is generated by AI from public sources. Was it useful?

About Novartis

Novartis

novartis.com

View company

Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. It focuses on innovative medicines, generics, and eye care.