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The Clinical Study Lead plans and manages overall clinical operations for assigned global clinical trials/projects with a primary focus on pharma collaboration, companion diagnostics projects for US registration. This includes timelines, budgets, resources, investigational sites, vendors and key project deliverables in compliance with SOPs, regulatory requirements and ICH/GCP guidelines and in alignment with Strategic & CDx partnership strategies and goals. Following the outlined strategy the Clinical Study Lead designs, implements, and monitors clinical studies of new and modified in vitro diagnostic products with respect to established policies, procedures, regulations, and Good Clinical Practice (GCP). The Clinical Study Lead serves as a project team member and coordinates the overall clinical project activities with other functions (e.g. RA, MA, QA) including long-term, next stage planning.

Accountabilities Designs the clinical development strategy in conjunction with the project team. Prepares clinical study plans that meet product design goals, regulatory requirements, business needs according to Biocartis procedures. Acts as point of contact to external stakeholders (i.e. Pharma) on ensure alignment on all aspects of clinical study design and execution. Manage all aspects of contracted clinical service providers (i.e. CRO s, etc.) and acts as the point of contact for all contracted clinical service providers. Proposes and negotiates budgets for clinical studies. Works with the statistical scientist to define the study design and statistical analysis of clinical data. Ensures site compliance with clinical study protocol and ICH/GCP guidelines. Leads the development of study-related documents, including study protocols, informed consent documents, study manuals and plans, trial master files, case report form design, etc. Ensures data integrity through completeness, accuracy, and legibility. Complies with all policies, established procedures, and regulations related to clinical research. Actively participates as member of cross-functional project teams, ensures cohesion between analytical and clinical activities, and lends support as needed across to cross-functional validation activities. Participates in assessing performance data generated by cross-functional teams. Acquires understanding of the Idylla platform principles and hands-on knowledge/skills in performing assigned assays. Provides clinical support to (clinical) feasibility studies. Maintains accurate and timely sponsor/site correspondence and communication. Reviews data, prepares, and presents clinical data reviews and summaries. Responds to audit and data queries. Prepares and presents project progress reports to keep management and team informed. Participates in preparation of the clinical sections of regulatory submissions packages and assists in responding to requests from the regulator regarding the clinical study. Participates in publication/presentation of clinical data in professional journals or meetings. Functions independently in the field and interacts with all levels of medical and scientific professionals.

Profile requirements Masters Degree in a scientific field (preferred) of study with 5+ years of relevant experience working in Clinical Operations in the Pharmaceutical/ biotech industry/medical device and/or a CRO. CRA experience preferred. Experience with trial master file organization, regulatory documents, inspection preparation/readiness (site and Sponsor) and all aspects of trial and vendor management. This position requires understanding of - scientific, statistical, regulatory and compliance requirements of clinical research - operational management clinical studies for regulatory submissions (US, CE) - clinical laboratory - assay/instrument principles involving in vitro diagnostic product design and usage - project management High degree of competence in clinical research and experience in all aspects of a clinical research program. Strong practical knowledge of compliance and regulatory environments (US, EU). Experience in Medical Device and Companion Diagnostics projects is an asset. Specific professional knowledge : - Scientific and technology background in molecular diagnostics - Strong working knowledge of GCP and IHC guidelines - Scientific and technology background (nucleic acids, real-time PCR, and/or molecular diagnostics experience preferred) - Proven experience with KOL-, CRO- and international project management - Experience in IVD (clinical) development and validation studies - Affinity with clinical drug development is an asset - Experience in organizing and executing clinical studies for regulatory submissions Strong communication and listening skills Proactive attitude Self-starter Excellent interpersonal and team working skills Significant degree of autonomy Collaborative problem solver, handles conflict constructively Excellent technical writing and documentation skills Well-developed organization, planning and prioritization skills Able to work under pressure and have a flexible approach Diplomatic and able to maintain secrecy concerning strictly confidential information Quality minded with attention to detail Willing to travel frequently - internationally Able to coach and mentor Languages : fluent in English, both spoken and written PC skills : MS Office, eDC systems is an asset

Biocartis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Biocartis complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Biocartis in the U.S.
Associated topics: antibody, aseptic, dietician, industrial hygienist, injury, medicine, nephrology, patient, protein, therapy

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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