Clinical Project Manager

The Study Lead Country Operations (SLCO) is the primary point of contact for the Country Operations (CO) team at the global study level and will act as a core study team member. The SLCO will be accountable for coordinating and driving activities performed by country operations including start up, monitoring, site oversight, quality and specific study deliverables. The SLCO will, therefore, be involved in study documentation review, coordinating CO activities globally, and will act as a liaison for other key stakeholders for relevant site and monitoring issues at country level.

The SLCO be responsible for liaising with Country Operations personnel to conduct the feasibility process, providing feedback to the study team regarding potential site and patient numbers.

The SLCO is responsible for utilizing and interpreting data from analytic tools, in conjunction with country and regional intelligence to proactively identify risks to quality and compliance and to develop and implement mitigation plans to address these risks.

The SLCO may be required to visit sites with the CRAs (CRO, FSP or in-house as applicable), or with other personnel (e.g. CO, Global Medical Affairs, etc.) for Sponsor Oversight, Inspection Readiness or Engagement Visits.

Job Accountabilities & Responsibilities

Accountable for

• Monitoring and site oversight globally assigned study(ies), representing the monitoring function on the Global Study Team

• Aggregation and communication of deliverables for assigned study(ies), globally, to the Clinical Program Lead (CPL)

• Resourcing and training of Functional Service Provider (FSP) CRAs for assigned study(ies) Validating local CRO resources, as necessary, to support execution of the study(ies)

• Developing and/or reviewing applicable study documents including training materials and reports

• Delivery of appropriate protocol and indication training to Country Operations teams

• Coordinationof start up and recruitment activities at the study level, across all countries

• Ensuring deployment of inspection readiness measures: including preparation of tools and required documentation

Responsible For:

• Liaison between Country Operations (CO) teams and the Global Study Team: act as the central point of contact for the CO team for assigned studies

• Standardization of study conduct and clinical monitoring proceses across study(ies)

• Collection of site nominations and communications thereof to the CPL

• Track trends occurring within the study that may impact other studies and communicate to the SLCO team and other key stakeholderes

• Together with the the SLCO team, standardize processes across the studies to improve efficiencies in CO activities

• Define monitoring requirements including components of Risk Based Monitoring (RBM)

• Support risk management and signal detection at a study level

• Act as a Subject Matter Expert for Sponsor Inspections by Regulatory Agencies or during audits

• Review quality metrics and provide solutions for continuous improvement

• Maintain a thorough knowledge of disease area and protocols

Essential Qualifications

• Extensive clinical trial experience across a range of highly complex disease areas

• Demonstrated capability of effective CRA and site oversight

• Solid knowledge of clinical development processes with strong emphasis on monitoring

• Track record of establishing effective relationships with investigator sites

• Ability to lead, troubleshoot and influence for quality and delivery

• A track record of ensuring GCP compliance and successful risk management of complex clinical studies is expected

• Ability to travel as required internationally and domestically. Demonstrates flexibility in schedule and willingness to travel up to 25%

Preferred Qualifications

• Bachelor's Degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences or drug development is required. A clinical or advanced degree (RN, MPH, MS, MA, MBA, PharmD) is preferred.

• 8+ years of clinical research experience in biopharma or CRO

• 4+ years of clinical project management wit regional or global scope

• Demonstrated project management skills across multiple highly complex clinical studies

• Experience of managing multiple studies including extensive experience in the management and oversight of CROs

• Experience of oncology clinical research is beneficial

We invite you to join IQVIA™

• Recognized by Great Place to Work as the second best company to work for (March 2019)

• FORTUNE Magazine's World's Most Admired Companies list for the third year in a row (January 2021)

• Recognized by the 2016 Scrip Awards as the Best Full-service Provider Contract Research Organization (CRO)

• Awarded the 2016 Eagle Award from the Society for Clinical Research Sites (SCRS) for the fourth consecutive year.

• A site-nominated award recognizing contract research organizations (CRO) and biopharmaceutical sponsors dedicated to building positive relationships with research sites through leadership, professionalism and integrity .

• IQVIA™ named in The International Association of Outsourcing Professionals (IAOP) 2017 Global Outsourcing 100® List which recognizes the world’s best service providers across a range of industries.

We know that meaningful results require not only the right approach but also the 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 whatever your career goals, we are here to ensure you get there!

Are you interested or do you know the ideal candidate?

• If you know the right candidate or for more information on this role please contact ana.rey@iqvia.com

• Please note is necessary that your application is registered in our Talent Network (WorkDay) to process your candidacy

#LI-Hybrid #LI-AR4

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

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