Associate Site Report Specialist

Job Overview
Provide project related assistance for assigned project(s) sites and project teams. Lead teams functionally where assigned including awareness of scope of work budget and resources. Ensure all work is conducted in accordance with SOPs policies and practices good clinical practices and applicable regulatory requirements and meets quality and timeline metrics.

Essential Functions
Draft and update the study monitoring Plan for Sponsor studies/protocols.
Preparing handling distributing filing and archiving of study related logs and form.
Assist with periodic review of study files for accuracy and completeness.
Assist with preparation handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
Develop Prepare & Maintain the Global study performance dashboard by acquiring data from primary or secondary data sources.
Assist the Study team in various phases such as planning maintenance and close out activities by providing detail analysis of the data as per the requirement in the form of report.
Assist the project team to mitigate the risk for a trial which is under high risk by giving detailed analysis report.
Support the project team and various stakeholders by accurately updating and maintaining the required data in the systems/tools within provided timelines.
Work with various stakeholders to prioritize business and information needs.
Responding to information requests from different stakeholders.
Resolving discrepancies in the data and obtaining further details for incomplete information.
Identify analyze and interpret trends or patterns for various metrics.
Analyze future and current end user requirements to improve clinical operations.
Engage in on the job training quality improvement initiatives and departmental orientation.
Track monthly retrospective quality issues for the internal team members
Collaborate with Information Technology and clinical staff to support defined business needs.
Design clinical and administrative reports.
Develop and analyze systems to obtain necessary output for specific requirements.
Perform administrative tasks to support team members with clinical trial execution as needed.
Advocate compliance with all standard operating procedures.
Assist with tracking and management of Case Report Forms (CRFs) queries and clinical data flow.
Meeting the Sponsor representatives/Trail Managers and proving support on study related activities
Assist in eTMF activity- filing/initial QC and classification of documents into TMF Perform detailed quality checks of documents uploaded into the TMFs
May be assigned role of systems expert - guiding teams on using of systems creating guidance documents updating trainings relevant to the systems and any new updates available in the systems. relaying the trainings to the team and be available to address the queries for the teams.
Provide SME support/Training and development
Responsible for Review & finalization of reports submitted by CRA within set timelines by applying GCP and applicable protocol knowledge.

Qualifications
Bachelors Degree Bachelors degree in a healthcare or other scientific discipline or educational equivalent

Req
3-5 years of Clinical Research experience including a minimum of 2 years on-site monitoring/remote monitoring experience.
Requires knowledge of principles theories and concepts of a job area typically obtained through advanced education.
Equivalent combination of education training and experience

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

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements misrepresentations or material omissions during the recruitment process will result in immediate disqualification of your application or termination of employment if discovered later in accordance with applicable law. We appreciate your honesty and professionalism.