Study Start Up Manager IQVIA Biotech

Job Overview
Direct and manage the delivery of all required site activation maintenance and regulatory activities for selected studies or multi-protocol programs including pre-award activities oversight of the scope of work budget and resources.

Essential Functions
Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy adhering to project timelines. Develop implement and maintain the 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 Regulatory & Site Activation 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 site activation 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 of site activation (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. May be involved in activities related to monthly study budget planning and reviews.

Qualifications
Bachelors Degree Life sciences or related field Req
7 years relevant experience in a scientific or clinical environment including demonstrable experience in an international role. Equivalent combination of education training and experience.
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

IQVIA est un fournisseur mondial de premier plan de services de recherche clinique dinformations commerciales et de renseignements sur les soins de santé pour les secteurs des sciences de la vie et de la santé. IQVIA se consacre à accélérer le développement et la commercialisation de traitements médicaux innovants pour aider à améliorer les résultats des patients et la santé de la population dans le monde entier. Pour en savoir plus visitez

IQVIA est fière dêtre un employeur souscrivant au principe de légalité daccès à lemploi. Tous les candidats qualifiés seront pris en considération pour un emploi sans égard à la race la couleur la religion le sexe lorientation sexuelle lidentité de genre lorigine nationale le handicap lâge létat matrimonial ou tout autre statut protégé par la loi applicable. Des mesures dadaptation pour les candidats handicapés sont disponibles sur demande dans tous les aspects du processus de recrutement. Si vous avez un handicap qui nécessite une mesure dadaptation nous vous encourageons à contacter notre équipe dacquisition de talents au afin quIQVIA puisse soutenir votre participation au processus de recrutement.

IQVIA sengage à faire preuve dintégrité dans son processus de recrutement et applique une politique de tolérance zéro en matière de fraude des candidats. Toutes les informations et toutes les qualifications soumises dans votre candidature doivent être véridiques et complètes. Toute fausse déclaration présentation trompeuse ou omission importante au cours du processus de recrutement entraînera la disqualification immédiate de votre candidature ou la cessation demploi si elle est découverte ultérieurement conformément aux lois applicables. Nous apprécions votre honnêteté et votre professionnalisme.

Veuillez noter quil est possible que nous utilisions lintelligence artificielle (IA) dans le traitement de votre candidature. Cependant nous utilisons lIA uniquement pour aider notre équipe de recrutement à sélectionner ou à évaluer les candidatures et non pas pour remplacer la prise des décisions par les membres de notre équipe.

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

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability age marital status or any other status protected by applicable law. Accommodations for applicants with disabilities are available in all aspects of the recruitment process upon request. If you have a disability that requires an accommodation we encourage you to contact our Talent Acquisition Team at: so that IQVIA can support your participation in the recruitment process.

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.

Please note that we may use artificial intelligence (AI) in the processing of your application. However we only use AI to assist our recruitment team with the screening or assessment of candidacies and not as a substitute for human decision-making.