Sr. Site Activation Specialist

IQVIA; São Paulo; On-site; BRL 90,000 - 140,000; Full time

Job summary

IQVIA in São Paulo, Brazil, is seeking a Site Activation Specialist to manage country-level activation activities in accordance with SOPs and project requirements. You will coordinate with SAMs, sites, and the PM team to ensure timely delivery of regulatory documents and IP release materials.

The role requires a life sciences background and hands-on clinical research experience, including leadership exposure.

Qualifications

• Bachelor's degree in Life sciences or related field is required.
• 3 years clinical research experience, including 1 year in a leadership capacity, is required.

Responsibilities

• Serve as Single Point of Contact (SPOC) for investigative sites, SAM, PM team, and other departments.
• Perform feasibility, site ID, start up and site activation activities per regulations and SOPs.
• Prepare site documents, reviewing for completeness and accuracy.
• Maintain internal systems and tracking tools with project information.
• Review and provide feedback to management on site performance metrics.
• Review project timelines and ensure monitoring measures and contingency plans.
• Inform team of completion of feasibility, site ID, regulatory, and IP release documents.
• Provide local expertise to SAMs and project team during planning.
• Perform quality control of documents provided by sites.

Skills

SPOC coordination

Clinical research

Regulatory knowledge

Documentation management

Quality control

Education

Bachelor's degree in Life sciences or related field

3 years clinical research experience incl leadership

Job description

São Paulo, Brazil

Full time

R1567108

Job Overview

Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activitie. Developing professional individual contributor who works under moderate oversight and supervision. Responsible for making recommendations for enhancements in systems and processes to solve problems or improve effectiveness of job area. Problems faced are general and may require understanding of broader set of issues but are not complex.

Essential Functions

• Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
• Perform feasibility, site ID, start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.
• Prepare site documents, reviewing for completeness and accuracy.
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
• Review and provide feedback to management on site performance metrics.
• Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
• Inform team members of completion of fesibility, site ID, regulatory and contractual documents for individual sites.
• Review, track and follow up the progress, the approval and execution of documents, questionnaires, CDA/SIF, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
• Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
• Perform quality control of documents provided by sites.
• May have direct contact with sponsors on specific initiatives.

Qualifications

• Bachelor's Degree Life science or related field Req And
• Other 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience.
• 3 years clinical research experience, including 1 year experience in a leadership capacity. Equivalent combination of education, training and experience. Req

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. Learn more at https://jobs.iqvia.com

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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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