Biomarker Sample and Data Manager
Biomarker Sample and Data Manager
Job Description550. 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 Sample and Data Manager your daily tasks and responsibilities will include but not be limited to the following:
• Lead, develop and implement innovative processes for clinical sample management, clinical sample and data flows in global trials driving sample planning, tracking and reconciliation. Serve as a global Subject Matter Expert (SME) and implementation lead
• Serve as a SME for
• clinical sample metadata set up with CROs (e.g. central labs), review study protocols, operations manuals, requisition forms (paper and electronic)
• BM/PK data set up, data transfer and data flow in LIMS, Data Transfer Specifications and eCRF
• Update study and sample information in relevant IT systems (e.g. sample tracking systems) according to study protocol amendments and/or reconciliation queries
• Oversee and contribute to managing bio-sample operational flows with CROs, external sample storage facility and internal stakeholders to ensure sample handling and processing steps for a range of analytical assays (sample aliquoting, profiling and additional research activities)
• Provide regular project/study level updates on bio-sample collection status and annotation accuracy to key stakeholders (e.g. develop specific KPIs)
• Develop fit-for-purpose reports for sample monitoring activities and provide outputs to clinical teams
• Collaborate with other TM and BMD functions and lead clinical operation processes, continuous improvement initiatives and innovations in LEO and BMD.
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 requirementsWhat you will bring to the role:
• BSc in life sciences with 7+ years experience or advanced degree with 3+ years of experience in clinical or laboratory operations or clinical data management/programming experiences
• SME and cutting edge knowledge of clinical data management and/or clinical programming and standards (e.g CDISC, SDTM, MedDRA)
• Strong knowledge of central laboratory operations, study start up (lab manual, requisition forms), clinical sample tracking/reconciliation and analysis
• Proven track records of independent contributions to global clinical studies and clinical operations is required (e.g. in CRO, biotech/pharmaceutical companies and/or central labs)
• Strong global project management, problem solving, influencing, communication and leadership skills
• Fluent in English as working language
• Knowledge of clinical sample management
• Track records of implementation of novel data management or clinical sample management solutions and systems is highly desired
• Experience with eCase Report Form development in web-based Electronic Data Capture (EDC) is highly desired.
• Experience with LIMS (Laboratory Information Management System) and knowledge of the clinical drug development process, regulatory requirements (e.g. GCP). Experience with visualization tools (e.g Spotfire) and/or reporting platforms (e.g Business Objects) is highly desired
• Information technology aptitude is required and programming/script language knowledge like Python, SAS, R, SQL is also desired
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!