Clinical Trial Manager, Oncology/I-O 1070084
Job Scope & Purpose:
Our high profile client focused in developing Immuno-Oncology therapeutics is seeking a Clinical Trial Manager to join an impressive team! The successful candidate will be responsible for providing trial management support for their cancer immunotherapy programs.
Primary Job Responsibilities:
- 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
- Proactive identification of potential risks and development/implementation of actions to avoid or mitigate
- Operational input into study documents such as synopsis, protocol, Informed Consent, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, etc.
- Participation in clinical service provider (vendor) selection, specification development, and management/oversight
- Development/coordination of study training for study team, investigational sites, and vendors in collaboration with medical and scientific colleagues
- Proactive management of issues and information sharing with key internal/external stakeholders with use of standardized reports and other mechanisms.
- Lead both an internal and external/CRO trial management team, to ensure the successful conduct in accordance with State and Federal regulations, GCP regulations, ICH guidelines, and internal SOPs
- Contribute to development of proactive strategy and corrective action plan to address trial issues in collaboration with cross functional team
- Responsible for supporting the management, oversight (CRO) and maintenance of the Trial Master File (TMF)
Primary Job Requirements:
- Bachelor's degree, or equivalent, in a biomedical, life science or related field of study with a minimum of 3 years of progressively increasing clinical trial management
- Experience within the Pharma, Biotech or CRO; Oncology/Immuno-oncology experience preferred
- Good understanding of US regulatory and compliance requirements for clinical research
- Solid teamwork, organizational, interpersonal, and problem-solving skills; exercises good judgment with respect to confidential information and strategies
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT
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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 firstname.lastname@example.org or 844-463-6178.