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.
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