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:

SYSTEMS AND DOCUMENTS MANAGEMENT:

• Registration on clinicaltrials.gov

• Respond to ct.gov inbox inquiries

• Sponsor specific systems management: site activation, transfer of obligations, etc

• EDL management

• Preparing, handling, distributing, filing, and archiving of clinical documentation and reports

• CSR Appendices management

REPORTING AND ANALYSIS:

• Assist the Study lead  in providing a periodic review of the prospective principal investigators to be selected for participation in the study

• Assist the Quality Team with Monthly Investigator Quality reviews, mitigation strategy calls and preparation of Meeting minutes

TEAM MANAGEMENT:

Day to day management of the Project Management Associate (PMA) role:

• Provide oversight and documentation of trainings

• Provide technical guidance

• Perform quality control activities.

Qualifications

• Education: Bachelor's Degree Life sciences or related field. Completed Project Management Fundamentals course is preferred, Advanced is a plus.

• Typically requires minimum 5 years of relevant experience.

• CRO experience at leadership client-facing roles in Project Management / TMF Management / Clinical Operations Management / Site Management / Site Activation Management / Real World Evidence with minimum 2 years of experience in the role

• Experience as Subject Matter Expert (SME) and/or Trainer and/or Mentor.

• At least 3 years of experience with Clinical Trial Management systems (CTMS) and/or Veeva Vault eTMF and/or EDC (Medidata).

• Experience in clinical site monitoring / centralized monitoring and/or clinical report review experience

• Advanced knowledge of Project Management principles – Planning, Resourcing, Execution, Oversight, Risk Management

• Experience with Regulatory Management systems and Contract Management systems is a plus.

• Good software and computer skills, including MS Office applications/ Advanced level of Excel (Macros, Analytics).

• Strong written and verbal communication skills including good command of English language

• Results and detail-oriented approach to work delivery and output

• Good problem solving skills

• Good planning, time management and prioritization skills

• Good leadership skills

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