IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients.
Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
PURPOSE Direct and manage the delivery of all required start-up, maintenance and regulatory activities for selected studies or multiprotocol programs as determined by either the agreed algorithm or the Sponsor's requirements, including pre-award activities, oversight of the scope of work, budget and resources. RESPONSIBILITIES
Oversee the execution of Start Up (including pre-award / bid defense activities) and / or Maintenance for assigned projects in accordance with the agreed RSU strategy, adhering to project timelines.
Develop, implement and maintain the RSU Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required.
Ensure collaboration across RSU, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.
Create and / or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team.
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 RSU plan.
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.
Execute operational strategy / expectations for maintenance of clinical study approvals, authorizations and review / negotiation of contracts and essential documents.
Work with Quality Management to ensure appropriate quality standards for the duration Start Up (or Maintenance, as applicable).
Mentor and coach colleagues as required.
Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information.
May take a lead role in developing long standing relationships with preferred IQVIA customers.
Deliver presentations / training to clients, colleagues and professional bodies, as required. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Strong negotiation and communication skills with ability to challenge
Excellent interpersonal skills and strong team player
Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects
Thorough understanding of regulated clinical trial environment and in depth knowledge of drug development process
Demonstrated proficiency in using systems and technology to achieve work objectives
Good regulatory and / or technical writing skills
Strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines
Good leadership skills, with ability to motivate, coach and mentor
Good organizational and planning skills
Ability to exercise independent judgment taking calculated risks when making decisions
Good presentation skills
Proven ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
Excellent understanding of study financial management
Proven ability to work on multiple projects balancing competing priorities MINIMUM REQUIRED EDUCATION AND EXPERIENCE Bachelor's degree in life sciences or related field with 7 years' relevant experience in a scientific or clinical environment including demonstrable experience in an international role;
or equivalent combination of education, training and experience. PHYSICAL REQUIREMENTS
Extensive use of keyboard requiring repetitive motion of fingers.
Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
Regular sitting for extended periods of time. Join Us Making a positive impact on human health takes insight, curiosity, and intellectual courage.
It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning. At IQVIA, we have a vision. Where every healthcare decision is based on evidence.
Where data science and human science come together to improve global health. Where new and creative solutions aren't just possible - they are expected.
Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare.
The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease.
We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you're supported to succeed.
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