Biomarker Scientific Monitor & Study Coordinator (Sr. Scientist II)

324823BR
Aug 04, 2021
USA

Job Description

550. That’s the number of concurrent clinical trials that Novartis is sponsoring at any given time.

Novartis Institutes for BioMedical Research (NIBR) is the global pharmaceutical research organization for Novartis committed to discovering innovative medicines that treat disease and improve human health. Laboratory Excellence and Operation (LEO) is the key global resource for Line functions (LF) and NIBR Clinical Trial Teams for biomarkers including biomarker outsourcing, scientific biomarker monitoring, vendor management, biomarker logistics, clinical site communication and sample coordination. LEO is working in close collaboration with clinical teams, LF technology experts, Biomarker Experts (BMEs) as well as external service providers (ESP) including central labs and clinical sites. LEO motto and drive is “Right samples, right lab, right time and right quality”.

As Biomarker Scientific Monitor & Study Coordinator (Sr. Scientist II) your daily tasks and responsibilities will include but not be limited to the following:

• Develop and provide operational reviews of global clinical study protocols, site operations manuals, informed consent forms, sample collection table, instruction manual, central lab protocol/manual, and eCRF and other biomarker sample logistics including study start up/setup, sample tracking/reconciliation, assay set up and sample/data upload. You may also serve as a SME in one more operational areas

• Independently place, set up, implement and monitor “fit for purpose” complex biomarker assays at external service providers (ESP) in one or several biomarker modalities (e.g. Flow cytometry, Immunoassay, LC-MS, genetics etc .) in TM clinical studies. You may also serve as a Subject Matter Expert (SME) in one of the biomarker modalities

• Support data transfer and data flow in LIMS and DTS (e.g. study creation, data flow, data transfer, etc.) for managed biomarkers and studies. Update study and project information in relevant IT systems

• Ensure quality and compliance of global external service provider (ESP) and their deliverables. Independently lead the development of new ESPs, including on qualification, on boarding, communication, and oversight.

• Identify, escalate and resolve complex assay troubleshooting, sample management or ESP issues, quality or performance issues and engage LF experts, clinical trial leaders and data management as needed

• Collaborate with other TM and BMD functions and lead clinical site processes, continuous improvement initiatives and innovations in LEO and BMD.

• Serve as Biomarker Expert (BME) in global TM clinical studies and contribute to the biomarker strategy and the study design

Diversity & Inclusion / EEO

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum Requirements

What you will bring to the role:

• BS in life sciences with 7+ years of experience or advanced degree with 2+ years in clinical operations and/or clinical bioanalysis, as well as training/experiences in global clinical study operation, vendor management and/or laboratory.

• Strong scientific knowledge of global study start up, clinical operations, clinical sample analysis and management of external service provider (ESP).

• Proven track record of independent contributions to global clinical studies and clinical operations is required.

• Experience working with ESP and monitoring biomarker work at external service providers (ESP) and data flows (LIMS, DTS, etc.)

• Method development and troubleshooting experiences for complex bioanalytical and biomarker assays.

• Knowledge of the drug development process and regulatory requirements e.g. GCP, GLP, etc

• Strong global project management, problem solving, influencing, communication and leadership skills.

• Fluent in English as working language.

Desirable:

• Understanding of central lab operations

• Laboratory knowledge and subject matter expertise in one or more technologies (e.g. Flow cytometry, MS, ELISA, bioanalysis, etc.) is strongly preferred

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!
NIBR
Translational Medicine
USA
Cambridge, MA
Research & Development
Full Time
Regular
No
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324823BR

Biomarker Scientific Monitor & Study Coordinator (Sr. Scientist II)

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