CSR Document Specialist at IQVIA in Sofia, Sofia-Capital, Bulgaria

CSR Document Specialist Location: Sofia, Bulgaria Job Overview CSR Document Specialist are an integral part of clinical trial delivery, working alongside clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Associate Clinical Lead is a member of the core project team responsible for clinical delivery of clinical studies to meet contractual requirements in accordance with Standard Operating Procedures (SOPs), policies and practices. Associate Clinical Leads partner with Project Leaders and other functional teams to secure delivery requirements are met at all times. Essential Functions • Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans). • Accountable for meeting projects’ recruitment targets and ensuring appropriate recruitment strategies are in place. • Contribute to the development of the project risk mitigation plan and manage clinical risks throughout the project’s lifecycle. • Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues. • Manage clinical aspects of Project Finances including Estimate at Completion (EAC). Understand the scope of clinical delivery and create plans to deliver. Monitor and manage changes against baseline Estimate at Completion (EAC) and identify additional service opportunities or out of scope work. • Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management. • Collaborate with the clinical team to support milestone achievements. Report to internal and external stakeholders as per project scope requirements. • Resourcing and Talent Planning of the clinical team. Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance and project related trainings. • Conduct regular team meetings and communicate appropriately to achieve objectives. • Support professional development by providing feedback to clinical team line managers on performance relative to project tasks. •  May work as the sole Clinical Lead on projects with 1-2 service lines and single/few countries or alongside more senior Clinical Leads to deliver large, global trials.; • May attend site visits as applicable in support of project delivery. Qualifications • Bachelor's Degree Bachelor's Degree in health care or other scientific discipline required • Requires 3 years clinical research/monitoring experience or equivalent combination of education, training and experience.; • Requires good knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.; • Requires broad protocol knowledge and therapeutic knowledge.; • Requires good understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates. • Requires basic understanding of project finances.; • Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e., International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct.; • Communication - Strong written and verbal communication skills including good command of English language. • Problem solving - Problem solving skills. • Organization - Planning, time management and prioritization skills. • Prioritization - Ability to handle conflicting priorities. • Quality - Attention to detail and accuracy in work. • Results-oriented approach to work delivery and output.; and PowerPoint.; • IT skills - Good software and computer skills, including Microsoft Office applications including but not limited to Microsoft Word, Excel and PowerPoint.; • Collaboration - Ability to establish and maintain effective working relationships with coworkers, managers and clients. • Cross-collaboration - Ability to work across cultures and geographies with a high awareness and understanding of cultural differences. • Effective communication - Ability to influence without authority. • IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, innovation, Ownership). Please note this role is not eligible for the UK visa sponsorship. Please note: due to sponsor requirements for the role only candidates based in the listed location/s will be considered. Any applications from candidates based outside of these locations will not be considered. 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.