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Outsourcing Manager/ BioMarker Operations Manager_SAN_DDD_06_14
3 months ago
Duration: 06 months
Act as the project manager to support the externalization and operationalization of clinical biomarkers and bioanalytical activities for pre-clinical and clinical drug development.
Support the team on budget predictions, management and tracking for a clear understanding of the biomarker operations and their impact on the project.
Be the key point of contact for biomarker activities whether they are managed externally or internally to inform the team to make data driven decisions.
Oversee PK or ADA bioanalysis that is performed externally.
Identify and help onboard vendors for specific analysis, provide advice and support on scientific and technical aspects of analysis where possible.
Interact closely with Translational Medicine (TM) subteams to execute biomarker plans for clinical studies.
Monitor assay development, assay validation and sample analysis processes, ensure timely delivery of quality results in compliance with regulatory guidance.
Support final data import.
Interface with Central Labs and sample management team to ensure the sample logistics meet study requirements.
Work collaboratively with the CROs, ensure that all studies are managed in respect to timelines, budget, scientific integrity, and quality deliverables.
Assure all aspects necessary for contracting studies are in place. This includes developing and maintaining a strong working relationship with Procurement, Legal and other support functions to provide RFP (Requests for proposal/information), Legal Contracts, etc..
Collaborate with Quality Assurance to establish and perform audits and ensure that selected CROs respect the quality assumed by SANOFI
Major Responsibilities:
Hybrid schedule, 2 days onsite, manager is flexible on which two days are onsite but may also need the candidate to be flexible if there is a special need to change the day...
Actual title is Outsourcing Manager/BioMarker Manager... Person will interact with internal scientists/lab and external vendors/labs.
Ensuring vendors are in Sanofi system and if not, get them into the system by working with Legal Dept.
Will generate Purchase Orders and schedule experiments.
Must have Bioanalytical experience so they can help lab troubleshoot issues when applicable, Outsourcing experience preferred but the major focus/must haves should be at least 5 years (with masters or higher degree) or 10 years (with bachelors degree) bioanalytical experience, regulated experience, experience supporting clinical studies, biomarker ops or analysis.
MUST BE 5 years Pharma industry or 10 year pharma industry depending on level of degree.
Degree should be in bio, science, or chemistry. Needs strong communication and project management skills. Will have multiple projects going at the same time. Manager does not care for their research experience.
Experience counted must be clinical. Start ASAP. Strong possibility for extensions.
