The Study Project Manager II drives the connection between the asset and operational delivery and execution of one or more clinical research studies. Leading the delivery of clinical operational strategies to ensure studies are executed with quality and efficiency, on-time, within budget, and meet company objectives.
In this role, you will be responsible for executing the clinical evidence strategy for medical devices and support the development of this strategy to enable new and continued global market access. Partner with cross-functional teams to develop short- and long-term clinical evidence strategies, providing scientific expertise to guide business decisions. Lead all aspects of clinical research, ensuring compliance with Good Clinical Practice.
The Study Project Manager I drives the connection between science and operational delivery and ensures operational excellence in planning and execution of clinical research studies across all development stages. The Study Project Manager I is responsible for ensuring clinical research studies are executed with quality and efficiency, on-time, within budget, and meet company objectives. The Study Project Manager I serves as leader of one or more cross functional Clinical Study Teams.
The Sr. Clinical Biospecimen Operations Associate is responsible for the execution of biosample activities for clinical research studies utilizing Natera tests. This includes leading coordination of operational activities for project execution, conduct, and close-out in scope with the study contracts, clinical study protocols, and working closely with internal and external teams in compliance with study requirements and applicable regulatory requirements.
The Senior Clinical Research Associate (Sr. CRA) plays a critical role in the management, monitoring, and execution of clinical trials and is responsible for ensuring trials are conducted in compliance with regulatory requirements, company SOPs, and industry best practices. The Sr. CRA will work closely with cross-functional teams to ensure the successful execution of clinical studies.
As a Senior Biostatistician at Artera, you will provide statistical and scientific leadership across clinical and translational studies that advance our AI-driven products. You will collaborate with Biostatistics, cross-functional teams, and external partners to ensure rigorous statistical methodology for product development, support regulatory and reimbursement submissions, and contribute to post-market evidence generation.
In this position you will be acting as the statistical lead for one or multiple studies, providing technical leadership and statistical support on the design, conduct and execution of the clinical studies. You will partner closely with the cross-functional teams and provide expert biostatistics input on development plans, regulatory interactions, and study design. This includes authoring/review of statistics section in the protocol and analyzing the clinical study results, and ensuring statistical integrity.
Responsible for overseeing all aspects of clinical study management for a gene therapy product. Able to successfully manage one or more complex studies with minimal supervision. Responsibilities include study planning and execution, timelines, budget, clinical site and vendor management. Comfortable working independently, managing interactions with experienced clinical monitors and cross-functional internal/external project stakeholders.
As a member of Miltenyi Biotec's R&D department, you will lead multiple groups focused on analytical development to support Miltenyi's CAR-T cell therapy pipeline from early clinical development to commercialisation. Responsibilities include providing strategic direction, overseeing the development of novel analytical methods, and managing the project portfolio. You will also lead and mentor a team of scientists, fostering an innovative and collaborative working environment.
This position is responsible for collaborating with both internal and external stakeholders to deliver the execution of our Biostatistics strategy. The individual in this position will have the unique opportunity to participate in the rapid growth of a biotech startup.