• Monitor and own the progress of clinical studies at investigative sites • Ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards. • Coordinate activities necessary to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.) • Handle appropriately sized clinical trials, and support Project Managers with larger trials • Train and mentor junior staff members. • Interact directly with clients, initiate payments, and participate in proposal activities, including development and client presentations.

• Conduct site monitoring responsibilities for clinical trials • Provide oversight, leadership, and guidance in the management and execution of clinical trials • Ensure protocol compliance and assist with study recruitment • Review monitoring visit reports and ensure timely investigator site visits • Maintain regular contact with study sites to ensure protocol/GCP compliance • Participate in internal, client/sponsor, scientific, and other meetings as required

Role Description IQVIA Biotech is hiring a Clinical Research Associate in Spain! The ideal candidate will have varied therapeutic experience and be willing to work across multiple therapeutics including: Oncology, Hematology, Cardiovascular, etc. This role will be home-based in Spain. - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. - Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability. - Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. - Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. - Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase. - Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. - Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. - Collaborate and liaise with study team members for project execution support as appropriate. - If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. - If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. Qualifications - Bachelor's Degree in scientific discipline or health care preferred. - Requires at least 1.5 years of on-site monitoring experience. - Equivalent combination of education, training and experience may be accepted. - Organizational, time management and problem-solving skills. - Ability to establish and maintain effective working relationships with coworkers, managers, and clients. - Flexibility to travel. - Driver’s license. Company Description 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. At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere.

• Lead and drive the THV clinical training program through curriculum execution, standardization, content development, SME resource management, and documentation to ensure study compliance • Maintain regular contact and collaborate with partner THV clinical teams, cross THV partners, consultants, customers and network appropriately with relevant stakeholders • Develop content as it relates to specialist training topics for best in class practices as they relate to required non-procedural knowledge • Train and evaluate the quality of team members execution of specialist and physician training processes and documentation • Responsible for maintaining an audit ready environment for all aspects of regulatory and non-regulatory audits as it relates to training • Lead assessment of teams’ compliance to GSOPs, work instructions, protocols, LMS and regulatory requirements • Lead audit preparation efforts for THV including team education, process development, timeline management, communication and implementation • Identify, acquire, develop and maintain programs used for electronic documentation records and processes for both internal and external training • Strategically develop and lead the delivery of training programs for THV training on best practices, trends, regulatory requirements and published guidance, policy and procedure updates