Clinical Research Manager ( Project Management), Single Sponsor

Join us in our exciting journey!!

Job Overview

As an experienced Clinical Research Manager, you primarily accountable for the end to end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. For certain studies, the CRM could be responsible for several countries in a cluster.

Our clients are pharmaceutical companies who are dedicated and passionate about improving the lives of patients across several therapeutic areas.

The role: Responsibilities

• Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).
• Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
• Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
• Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
• Performs Quality control visits as required.
• Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration.
• Responsible for creating and executing a local risk management plan for assigned studies.
• Ensures compliance with CTMS, eTMF and other key systems in assigned studies.
• Escalates as needed different challenges and issues to TA Head/CRD/CQM and or CTT (as appropriate).
• Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies.
• Country POC for programmatically outsourced trials for assigned protocols.
• Serves local business needs as applicable in his/her country (If delegated can sign contracts and manage budgets).
• Collaborates internally with HQ functions and locally with PV, Regulatory and GMA to align on key decisions in his/her studies. GHH to be consulted as needed.
• As a customer-facing role, this position will build business relationships and represent the sponsor with investigators.
• Shares protocol-specific information and best practices across countries\clusters.

Our ideal candidate: Skills & other requirements

• Bachelor's degree in a health care or other scientific discipline or educational equivalent.
• Minimum 5-6 years of experience in clinical research. Knowledge in Project Management and site management is needed.
• Oncology experience is a big plus.
• In depth knowledge and skill in applying applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Requires strong understanding of local regulatory environment.
• Strong organizational skills with demonstrated success required.
• Strategic thinking.
• Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures and functions • Ability and skills to manage resource allocation, processes (and controls), productivity, quality and project delivery.
• Strong written and verbal communication skills including good command of English and Romanian.
• Based in Romania (Hybrid model).
• Travel expectations: up to 30% of working time.

#LI-Hybrid model #LI-JOYCEGUILLEN

What we offer

• Working with one of the TOP 5 sponsors globally on international projects.
• Focus on quality, not quantity! We invest in keeping our teams stable, so workload is consistent.
• The chance to work on cutting edge medicines right at the forefront of drug development.
• Genuine career development opportunities for those who want to grow as part of the organization.
• Flexible conditions and an attractive remuneration package.
• Hybrid model, field based and home based roles available!

We invite you to join IQVIA™

• Recognized by Great Place to Work as the second best company to work for in Spain (March 2019)
• FORTUNE Magazine's World's Most Admired Companies list for the third year in a row (January 2020)
• 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&rerg; 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 joyce.guillen@iqvia.com
• Please note is necessary that your application is registered in our Talent Network to process your candidacy

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