- Primary operational contact for execution of the study in compliance with ICH/GCP, Regulatory Authorities regulations/guidelines, and applicable SOPs/Work Instructions
- Development, management, maintenance of study deliverables [i.e. timelines, study plans, etc.] through collaboration with internal and external stakeholders
- Operational input into study documents such as synopsis, protocol, Informed Consent, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan,
- Participation in clinical service provider (vendor) selection, specification development, and management/oversight
- Bachelor's degree, or equivalent, preferably in a biomedical, life science or related field of study
- Minimum of 5 years of progressively increasing clinical trial management experience within the Pharma, Biotech or CRO; Oncology/Immuno-oncology experience required
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TScan Therapeutics Waltham, United StatesJob Description · Job DescriptionPosition Summary: · TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for a Clinical Trial Associate to join our Clinical Opera ...
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TScan Therapeutics Waltham, United StatesJob Description · Job DescriptionPosition Summary: · TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for a Clinical Trial Manager to join our Clinical Operati ...
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Sr./Clinical Trial Manager - Watertown, United States - Apex Systems
Description
Sr. Clinical Trial Manager
Location: Waltham, MA (Hybrid)
Therapeutic Area: Auto Immune
Job Overview:We are looking for a talented and curious professional to oversee study activities, manage relationships with study sites and vendors, and identify project risks and contingency plans in a fast-paced environment.
Primary Job Requirements:
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EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or
Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.