Offer summary

Qualifications:

Bachelor's degree in Life Sciences or related field., Proven experience in Trial Master File (TMF) management., Strong understanding of regulatory requirements and compliance., Excellent organizational and communication skills..

Key responsibilities:

Oversee the management and maintenance of the Trial Master File.

Ensure compliance with regulatory standards and internal processes.

Collaborate with cross-functional teams to ensure timely document collection.

Provide training and support to team members on TMF best practices.

For over 40 years, our team of 1,000+ experienced professionals have provided the full range of Contract Research Organization expertise necessary to conduct clinical research with a firm scientific basis that is fully compliant with national and international regulatory guidelines. With offices throughout the US, Europe, Canada, and India, Emmes supports the advancement of global public health and biopharmaceutical innovation through disciplined science, rigorous research, fact-based decision-making, and operational excellence. Emmes possesses knowledge across a broad range of therapeutic areas, with specializations in Vaccines and Infectious Diseases, Ophthalmology, Immunology and Neuroscience. From comprehensive support of pandemic research to groundbreaking work in cell and gene therapy across the globe, Emmes has collaborated on clinical research across a wide array of disease states in over 75 nations. As a strategic collaborator with applied talent in over 2,000 clinical trials and contributions to over 2,500 publications that advance the understanding of medicine and public health, Emmes is committed to expanding the services offered to best meet the changing needs of clients and studies. Ongoing investments in global clinical research capabilities, innovative data management platforms, biostatistics/bioinformatics expertise, and people have enabled Emmes to provide a multi-faceted approach to help you meet your research objectives. Emmes is a diverse, inclusive, innovative CRO that values integrity, agility, passion for excellence, collaborative partnerships, and intellectual curiosity.

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