Assoc. Site Activation Manager - Sponsor Dedicated

IQVIA; São Paulo; Presencial; BRL 120 000 - 180 000; Tempo integral

Resumo da oferta

IQVIA is seeking a Site Activation Manager to lead and oversee strategic, operational, and financial delivery of site activation activities for assigned studies at the local level. You will manage Site ID and Selection, Ethics and Regulatory processes, and Site Contracting to accelerate patient enrollment.

Responsibilities include strategic planning, project oversight to fast-track site activation, handling Start Up or Lifecycle Maintenance per plan, ensuring compliance with ICH-GCP and

Qualificações

• Bachelor's Degree Life Science or related field.
• At least 3 years relevant experience in a scientific or clinical environment.
• Experience in an international role or equivalent combination of education, training and experience.

Responsabilidades

• Provide strategic planning and project oversight accelerating site activation.
• Oversee Start Up and Lifecycle Maintenance for assigned projects in compliance with regulatory requirements.
• Develop and maintain the Site Activation Management Plan and report updates to the study team and senior colleagues.
• Ensure alignment with ICH-GCP, protocol, customer requirements and internal policies.

Conhecimentos

Project management

Regulatory knowledge

Communication

International experience

Formação académica

Bachelor's Degree Life Science or related field

Descrição da oferta de emprego

Job Overview.

Direct and manage the execution of the strategic, operational, and financial delivery of required Site Activation activities, including but not limited to Site ID and Selection, Ethics and Regulatory processes and Site Contracting for assigned studies at local level.

Essential Functions

• Provides strategic planning and project oversight accelerating Site Activation through best in class project management to ensure fast site activation for patient enrollment.
• Oversee the execution of Start Up (including pre-award through Site Activation) and/or Lifecycle Maintenance for assigned projects in accordance with the agreed start up strategy, adhering to agreed project timelines and in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol, customer requirements, and internal policies.
• Develop, implement and maintain the Site Activation Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required.
• Provide ongoing updates and reporting to various levels of the organization, both study team and in some cases senior level colleagues.

Qualifications

• Bachelor's Degree Life Science or related field. At least 3 years relevant experience in a scientific or clinical environment.
• Demonstrable experience in an international role; or equivalent combination of education, training and experience.
• In-depth knowledge of clinical systems, procedures, and corporate standards Strong knowledge of medical terminology and regulations.
• Effective communication, organizational, and interpersonal skills.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.