This Senior Clinical Operations Specialist is responsible for managing the oversight and implementation of biomarker strategic objectives as directed by the Heme DAS Biomarker Lead. Responsibilities include budget and contract management, sample quality, timeliness and biomarker administrative needs (budget, presentations and study documents).
This role is responsible for all budget and contract management related to Heme DAS biomarker related research agreements, 2 or 3 way collaborations, material ...
Director of Biotech Business Development - CRO
Growing contract research company seeks a Director of Biotech Business Development to develop and implement sales and marketing plans targeting key regional customers. We are seeking candidates for two positions, Director - Eastern and Director - Western states. Candidates could live in any major eastern or western metro. The Director of Biotech Business Development will:
Direct sales efforts, coordinating sales pipelines with external customers ...
Lead the clinical protocol development process in collaboration with the Clinical Program Leader (CPL): responsible author for clinical protocols, amendments and related documents; contribute to the medical/scientific input given for the development of trial-related documents and processes which reside in other line functions; obtain approval from internal review boards.
Contribute to the development of clinical sections of regulatory documents like Investigators’ Brochures, ...
• Lead the clinical protocol development process in collaboration with the Clinical Program Leader (CPL): responsible author for clinical protocols, amendments and related documents; contribute to the medical/scientific input given for the development of trial-related documents and processes which reside in other line functions; obtain approval from internal review boards.
• Contribute to the development of clinical sections of regulatory documents like Investigators’ Brochures, ...
Biologics company focused on cutting-edge Oncology research seeks experienced Clinical Operations manager to oversee trial activities, ensuring that project milestones and timelines are met, within budget.
Responsibilities to include:
** Participation in cross-functional teams for oversight and support of protocol development, regulatory compliance, bioethics reviews, etc
** Direct management of sample collection, bio-banking, data retrieval, and related activities
** Operational leadership ...
Seeking Ph.D with nucleic acid molecular biology assay development experience and familiarity with regulatory issues and filings to lead development, design, qualification and validation of real-time PCR and multiplex PCR assays to measure gene expression, copy number, genotype, translocations and other molecular characteristics of RNA or DNA for clinical and pre-clinical quantitative and qualitative biomarker and companion diagnostic studies.
*** Conduct assay design.
*** Develop and ...
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