General

• Support the management of clinical trial sites by assisting with site monitoring activities
• Ensure compliance with study protocols and maintain high standards of operational efficiency
• Assist in monitoring clinical trial sites for adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines
• Support site management activities, including documentation preparation, data entry, and tracking site performance metrics
• Collaborate with cross-functional teams to facilitate communication and address site-related issues
• Maintain accurate records of site activities and contribute to monitoring reports
• Participate in training and development initiatives

Study Delivery Specialist

• Provide strategic project and programme management support for complex business development, integration, separation and transition activities within Clinical Operations
• Bring structure and momentum to complex, high-priority initiatives
• Develop clear roadmaps and coordinate activities across functions
• Manage priorities, risks, dependencies and deliverables
• Work with senior stakeholders across Business Development, Clinical Operations, Clinical Development and other relevant functions
• Represent Clinical Operations in high-level cross-functional discussions
• Translate broader business objectives into clear, actionable deliverables
• Lead and facilitate workshops and establish ownership and governance
• Coordinate cross-functional stakeholders and directly lead selected initiatives when required
• Lead sub-workstreams and discrete programmes relating to integration, separation, transition and partnership opportunities
• Manage project roadmaps, milestones, dependencies, risks and actions
• Provide senior leadership visibility into priorities, risks, impacts, decisions and progress
• Establish and manage cross-functional working groups and governance forums
• Develop and implement processes, guidance and written standards for integration and post-deal activities
• Partner with internal teams and external vendors or partners to establish transition strategies and manage execution
• Identify, assess, mitigate and escalate project risks, issues and dependencies
• Lead or support issue management, CAPA development/response and change control activities
• Act as a subject matter expert for study delivery and integration/separation activities
• Travel selectively to support key integration activities, with some face-to-face interaction potentially required during early integration stages

Global Clinical Integration Lead – FSP EMEA

• Execute an effective and innovative sourcing strategy to identify exceptional talent
• Conduct complex internet searches using search engines, social media, direct/cold calls, networks, directories, recruitment tools, and databases
• Network and build robust candidate pools across positions and locations
• Conduct phone interviews and assess candidates against client position requirements and organizational culture fit
• Maintain strong client and candidate relationships and satisfaction
• Update and maintain applicant tracking system data and reports
• Participate in special projects as assigned

Technical Talent Attraction Specialist

• Perform key medical information contact center services
• Provide timely, accurate, and balanced responses to unsolicited requests for information to HCPs and patients using Biomapas or customers’ Medical Information System
• Analyze and interpret scientific data to update or develop comprehensive, balanced, credible and accurate response documents meeting applicable laws and procedures
• Exchange customer insights and scientific information with internal & external partners
• Ensure compliant execution of all MI and PV operational activities at high level of quality
• Engage in timely handling and reporting of safety information and product quality complaints
• Perform local operations and ensure compliance with safety regulations and procedures
• Review local literature and act as a local safety officer serving as the main contact for safety matters with authorities and customers, as applicable

General jobs in Romania

Study Delivery Specialist

Global Clinical Integration Lead – FSP EMEA

Technical Talent Attraction Specialist

Medical Information and Pharmacovigilance Specialist – Nordics