Manager, Clinical Research (Oncology)

Ankr Health; United States; Remote; USD 80,000 - 110,000; Full time

Job summary

Ankr Health recherche un Manager en recherche clinique (Oncologie) avec au moins 5 ans d'expérience. Ce rôle clé implique la gestion de projets cliniques, le respect des normes réglementaires, et la supervision des essais. L'opportunité inclut une formation continue et des voyages occasionnels à Houston. Les candidats idéaux auront une forte connaissance des essais cliniques et un engagement envers l'amélioration des résultats des patients.

Qualifications

• Minimum 5 ans d'expérience en gestion des essais cliniques.
• Expérience dans les entreprises pharmaceutiques ou CRO est exigée.
• Certification RAC, SOCRA ou équivalent nécessaire.

Responsibilities

• Superviser les activités des essais cliniques.
• Gérer les budgets, les délais et la conformité.
• Collaboration avec les équipes fonctionnelles pour assurer le succès des études.

Skills

Regulatory Management

Project Management

Budget Negotiation

Clinical Trials

Team Mentorship

Education

Degree in life science-related discipline

Tools

CTMS

Salesforce

PowerBI

Job description

Job Title: Manager, Clinical Research (Oncology)

Location: Houston, USA

Position: Contractor-Mid-career/Senior

Start Date: Immediate Joiners Preferred

About Us:

Ankr Health is a US-based company with offices in San Francisco, Houston, and Bangalore. We create transformative technologies for clinics and hospitals to improve patient outcomes. Our flagship platform is the # 1 side effect management solution for oncology and surgery.

Ankr also has an industry-first, generative AI-powered virtual clinics-as-a-service platform. Learn more at https://ankrhealth.com

Job Summary:

We are seeking a highly experienced Manager, Clinical Research (Oncology) with a minimum of 5 years of experience in clinical trials regulatory management. The ideal candidate will have worked in either a pharmaceutical firm and a clinical research organization (CRO) and have hands-on experience with investigative studies and clinical trials.

This is a critical leadership role that combines regulatory oversight, clinical project management, budget/contract negotiations, and team mentorship. We’re looking for a hands-on leader capable of managing multiple sites, vendors, and stakeholders while ensuring adherence to timelines and GCP compliance.

Job Description:

• The Manager for Clinical Research (Oncology) will be responsible for overseeing the spectrum of activities for clinical trials in our research division. This role will involve providing independent regulatory support for complex projects and programs. The ideal candidate will demonstrate a strong understanding of clinical research regulations and possess comprehensive regulatory expertise.
• Take a lead role in the planning and execution of clinical trials, ensuring adherence to timelines, budgets, and quality standards
• Develop and oversee study scope of work, budgets and timelines
• 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

Minimum Required Education and Experience:

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

Experience:

• At least 5 years of relevant experience in clinical trials regulatory management, with demonstrated regulatory and project management leadership.
• Experience working in research division of pharmaceutical firm or a clinical research organization (CRO) is required.
• Experience with investigative studies and clinical trials is strongly preferred.
• Supervisory experience in managing personnel or processes for regulatory affairs within a research organization is strongly preferred.
• Proven ability to oversee Phase I–III trials including gene therapy, oncology, and rare diseases.

• RAC, SOCRA, or equivalent certification is required and must be maintained throughout duration of employment.
• GCP training certification/recertification within 2 years is required
• Strong background in contract and budget negotiation, project finance tracking, and client/vendor management.
• Advanced experience with CTMS, Salesforce, PowerBI, and site budget management tools.
• Mentor junior team members, promote best practices, and support GCP QA during audits and inspections.
• Represent Ankr Health in bid defenses, investigator meetings, and client presentations.

Working Conditions:

• Remote with occasional travel to Houston or other trial sites.
• Must have reliable internet access and be comfortable with digital collaboration tools.
• This is a contractor role with potential for longer-term engagement based on performance.