Global Site ID Lead - based Europe at IQVIA

Job Overview

• Individual contributor with knowledge acquired from years of experience in the professional discipline, who works under close - moderate supervision. Problems faced are general and may require understanding of broader set of issues but are not complex. Perform tasks at a project level associated with Site Identification and Selection Activities for selected studies, in accordance with applicable international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. Responsible for making recommendations for enhancements in systems and processes to solve problems or improve effectiveness of job area.

Essential Functions

• Provides strategic planning and project oversight accelerating Site ID & Selection through best-in-class Site ID that ensure utilization of the highest performing sites to decrease non-enrolment.
• Responsible for driving the quality of site utilization within the post award landscape.
• Accountable for the Site ID strategy handover including understanding the clinical trial concepts, translating clinical strategy into an applicable format that can drive Site Vetting decisions to accelerate Site ID.
• To successfully deliver the agree Site ID strategy GSID lead will be responsible for scheduling/ driving key meetings with stakeholders, which may require data mining, analysis, formulate recommendation, or root cause analysis, when strategy milestone (s) are not achieved.
• Collaborate with key stakeholders both internal and external, through effective communication and resolution management, including communication with regions and countries, to successfully deliver the agreed Site ID strategy.
• Provide ongoing updates and reporting to various levels of the organization, both study team and in some cases senior level colleagues.
• May take a lead role in developing long standing relationships with preferred IQVIA customers: maintain and develop the customer relationship through work at the study team level.
• Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), Site ID system (s), timelines, and project plans with project specific information.
• Contribute to initiatives that affect positive change within the department and organization: support department initiatives.
• Support Site ID and Selection for their selected studies towards the agreed department targets and goals.
• Ensure team members in local Site ID are aware of the agreed targets and goals.
• Actively seek knowledge to become a subject matter expert in required tools and processes in the Site ID and Selection space.

Qualifications

• Bachelor's Degree Life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training, and experience.
• Good negotiation and communication skills with ability to challenge to ensure best processes, timelines and solutions are delivered.
• Good understanding for risk assessment and mitigation/solutioning for site ID and selection items.
• Good interpersonal skills and strong team player.
• Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects.
• Thorough understanding of regulated clinical trial environment and in-depth knowledge of drug development process.
• In-depth knowledge of clinical systems, procedures, and corporate standards.
• Good regulatory and/or technical writing skills.
• Good knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines.
• Good leadership skills, with ability to motivate, coach and mentor.
• Good organizational and planning skills. Good presentation skills.
• Ability to demonstrate strategic thinking while exercising independent judgment and taking calculated risks.
• Ability to establish and maintain effective working relationships with co-workers, managers, and sponsors.
• Ability to work on multiple projects balancing competing priorities.
• Proactively identifies potential obstacles to critical path and provide potential solutions and action plan.
• Escalates appropriately and follows to resolution.