IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
ROLE AND RESPONSIBILITIES:
• Conduct periodic review of site level KRIs and historic site performance according to Central Monitoring Plan
• Early identification of site-level risk/issue(s) occurring during study conduct and responsible for identification of risk
• Monitor site performance and make recommendations for timely corrective actions (e.g. Site Telephone Contact or Triggered Onsite Monitoring Visit)
• Review the effectiveness of the recommended actions and take appropriate additional actions if no effect is observed.
• Work in accordance of the Study Central Monitoring Plan.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
• Establish and maintain effective project/ site level communications with relevant stakeholders
• Maintain relevant project documents.
• Collaborating with peer business process specialists and promoting cross functional synergies.
• Project Oversight to site management activities on assigned projects and evaluate the quality and integrity of the study as per the protocol, SOPs respective regulation& guidelines.
• Attend Kick-Off meetings, weekly team meetings, and client meetings, as per the project specific needs.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
· Advanced knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements; i.e., ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. Familiarity with related systems and software utilized in clinical operations.
· Strong written and verbal communication skills including good command of English language
· Results and detail-oriented approach to work delivery and output
· Understanding of clinical/medical data.
· Excellent motivational, influencing and coaching skills
· Ability to work on multiple projects and manage competing priorities
· In depth therapeutic and protocol knowledge
· Strong communication and interpersonal skills, including good command of English language
· Strong organizational and problem solving skills
· Demonstrated ability to deliver results to the appropriate quality and timeline metrics
· Good judgment
· Effective presentation skills
· Ability to manage competing priorities
· Ability to work across cultures and geographies with a high awareness and understanding of cultural differences.
EDUCATION AND EXPERIENCE:
Candidates should be life science Post graduates and/or health science background with 2-5 yrs of experience in to Clinical research/Site monitoring/remote monitoring. Experience in Centralized Monitoring will be preferred
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.