Maintenance Lead

Job Overview

Direct and manage the execution of the strategic, operational and financial delivery of revised clinical study documents and regulatory activities included but not limited to participation in revised clinical study documents meetings, Ethics and Regulatory processes, Site Contracting and implementation of evised clinical study documents for assigned studies as determinded by Company, scope of work and oversight of the scope of work and/or sponsor requirements.

Essential Functions

• Provides strategic planning and project oversight accelerating implementation of revised clinical study documents through best in class project management to ensure fast implementation ;
• Support and/or participate in pre-award/bid defense activities, for transitioned studies from other CROs/Pharma;
• Oversee the execution of Lifecycle Maintenance for assigned projects in accordance with the agreed strategy, adhering to agreed project timelines and in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol, customer requirements, and internal policies.;
• Study Delivery Scope minimum expectations: accountable for high size and medium complexity studies;
• Develop, implement and maintain the Site Activation Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required.;
• Collaborate with key stakeholders both internal and external, through effective communication and resolution management, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the Site Activation Management Plan.;
• Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents.;
• Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.;
• Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations; identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the Site Activation Management Plan.;
• Provide ongoing updates and reporting to various levels of the organization, both study team and in some cases senior level colleagues.;
• Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information.;
• Create and/or review technical and administrative documentation to support business development and enable study maintenance, as required.;
• Adhere to quality standards, regulated and Company specific through the duration of the trial period.; Mentor and coach colleagues as required: mentor to Grade 140;
• May take a lead role in developing long standing relationships with preferred IQVIA customers:Maintain and develop the customer relationship through study teamwork and support providing input to customer level processes and/or initiatives , attend Early Engagement Customer or Partnership Meetings if required.;
• Deliver presentations/training to clients, colleagues and professional bodies, as required.;
• Contribute to initiatives that affect positive change within the department and organization: support department initiatives.;
  
  

Qualifications

• Bachelor's Degree Life sciences or related field Req
• At least 5 years with 2 years of lead experience in a scientific or clinical environment.;
• Demonstrable experience in an international role; or 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 https://jobs.iqvia.com

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.