Manager, Clinical Research (Oncology)

·       Develop and maintain study documents, such as SDC, protocols, informed consent forms, and study manuals, in accordance with company and regulatory standards

·       Facilitate the initiation of new studies, including completion and accurate submission of all amendments to the PRMC (protocol review and monitoring committee), Institutional Review Board (IRB), adhering to regulatory guidelines and protocols

·       Manage and oversee the day-to-day operations of assigned clinical trials, including monitoring progress, identifying and resolving issues, and ensuring compliance with regulations

·       Collaborate with cross-functional teams, including study managers, data managers, and medical professionals, to ensure successful study outcomes

·       Communicate with external partners, such as investigative sites, co-sponsors, and vendors, to establish and maintain effective relationships

·       Monitor and track study progress, maintain CTMS, EDC, regulatory binders

·       Providing regular updates and reports to senior management and stakeholders

·       Participate in the selection and management of investigative sites, ensuring they have the necessary resources and training to conduct the study

·       Ensure compliance with company policies, standard operating procedures, and regulatory requirements

·       Identify areas for process improvement and implement solutions to increase efficiency and effectiveness

·       Mentor and provide guidance to team members on best practices and industry standards

·       Stay current with industry trends and developments, and apply knowledge to enhance study processes and outcomes

·       Represent the company at conferences and meetings, promoting the organization's mission and values

·       Maintain confidentiality of all sensitive information and adhere to ethical standards
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Minimum Required Education and Experience:

·       Education: Degree in life science-related discipline or professional equivalent.

·       Experience:

o   At least 5 years of relevant experience in clinical trials regulatory management.

o   Experience working in research division of pharmaceutical firm or a clinical research organization (CRO) is required.

o   Experience with investigative studies and clinical trials is strongly preferred.

o   Supervisory experience in managing personnel or processes for regulatory affairs within a research organization is strongly preferred.

o   RAC, SOCRA, or equivalent certification is required and must be maintained throughout duration of employment.

o   GCP training certification/recertification within 2 years is required
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·       Physical Requirements:

o   Extensive use of telephone and face-to-face communication requiring accurate perception of speech.

o   Extensive use of keyboard requiring repetitive motion of fingers.

o   Regular sitting for extended periods.

o   Travel may be required.

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