Join us on our exciting journey!IQVIA is The Human Data Science Company, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity 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
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
We know that meaningful results require not only the right approach but alsothe right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA
Job ID: R1066335