Looking to make a meaningful impact in clinical research while working remotely? This role offers the opportunity to take ownership of site management activities across the full study lifecycle, partnering closely with investigators and cross-functional teams to bring innovative therapies to patients faster.

Job Overview
With limited guidance, responsible for remote site monitoring activities to ensure sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. May monitor and/or co-monitor on-site when needed. May perform Site Identification (Site ID) and/or Site Start-Up (SSU) activities.

Essential Functions
• Completes appropriate therapeutic, protocol and clinical research training to perform job duties. Works collaboratively with other functional groups such as Clinical Operations Lead (COL), Project Management, Regulatory Start-Up (RSU) and Epidemiology.
• Performs as needed, Site ID, and site selection activities according to applicable regulations and Standard Operating Procedures (SOPs) including but not limited to: Collection of Site Information Form (SIF) and Confidentiality Disclosure Agreement (CDA) and corresponding tracking and filing and might perform Site Selection Visits (SSVs) as needed.
• Performs as needed SSU activities according to applicable regulations and SOPs, including but not limited to: preparing regulatory/ethics submission packages and obtaining required approvals; collecting and reviewing of regulatory documents for completeness and accuracy; tracking and filing  site regulatory documents (Including regulatory /ethics submissions / Approvals, Informed Consent Form (ICF) and others), preparing, reviewing and negotiating of site contracts and budgets with investigator sites; reviewing and agreeing on project planning and project timelines.
• Performs as needed, initiation, monitoring and close out visits remotely and in accordance with contracted scope of work, using Good Clinical Practices (GCP), applicable regulations, SOPs and work instructions. May monitor and/or co-monitor on-site when needed.
• Serves as primary contact between the business and the investigator site and ensures proper documentation of site management communications. Serves as back-up to other Site Managers (SMs).
• In collaboration with the assigned field Clinical Research Associates (CRAs), performs routine site management activities, including, as needed: SSU activities as detailed above, site training, assistance with site questions, patient recruitment and retention management, study supplies management, and other activities needed to ensure that assigned sites are conducting the study(ies) as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
• Collaborates with field CRAs, as needed, to resolve and document outstanding site issues/action items.
• Reviews the quality and integrity of patient data at assigned sites through the remote review of electronic Case Report Form (CRF) data. Ensures timely transmission of clinical data from assigned study sites and works with sites to resolve data queries.
• Assists with final data review, query resolution and patient casebook signature through database lock. Inclusive of patient profile and data listings review.
• Ensures accurate completion and maintenance of internal systems, databases and tracking tools with site specific information, including (but not limited to) submitting regular visit reports, generating follow-up letters, collection and filing of essential documents and other required study documentation.
• Provides input and updates to the assigned COL regarding site status and deliverables. Escalate issues and/or risks related to site performance to the COL, Clinical Project Manager (CPM) and/or Line Manager (LM) as needed.
• May assist with and attend (as needed) Investigator Meetings on assigned studies.
• Authorized to request onsite visits and/or site audits for reasons of validity.
• May help ensure timely and appropriate site payments and updates to systems as required to ensure proper timing and amount of payments.
• May conduct assessment visits, as needed, to ensure monitoring is being conducted in accordance with the protocol, SOPs, GCP and applicable regulatory requirements.
• May provide assistance to less experienced clinical staff, including demonstrating appropriate interactions with sites, documentation and other monitoring activities.
•  May be assigned COL tasks on exceptional basis, as agreed with LM.

Qualifications
• Bachelor's Degree Bachelor's Degree preferred or as required by local country policies.  Degree in scientific discipline or health care preferred. Pref
• Minimum of 2 plus years of relevant clinical experience preferred. Pref
• Equivalent combination of education, training and experience may be acceptable. Pref
• Intermediate knowledge of clinical research process and medical terminology.
• Written and verbal communication skills including good command of English language.
• Good organizational and problem-solving skills.
• Ability to manage multiple priorities within various clinical trials.
• Ability to meet deadlines and adhere to project timelines.
• Ability to work independently on routine tasks and apply critical thinking to tasks with guidance, as needed.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Ability to understand electronic data capture including basic data processing functions.
• Intermediate knowledge of current International Conference on Harmonization (ICH) and GCP guidelines and applicable regulations to the conduct of clinical research.
• Skill in understanding different study designs.
• Computer skills including proficient use of Microsoft Word and Excel.

IQVIA est un fournisseur mondial de premier plan de services de recherche clinique, d'informations 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 https://jobs.iqvia.com

 

IQVIA est fière d’être un employeur souscrivant au principe de l’égalité d’accès à l’emploi. Tous les candidats qualifiés seront pris en considération pour un emploi sans égard à la race, la couleur, la religion, le sexe, l’orientation sexuelle, l’identité de genre, l’origine nationale, le handicap, l’âge, l’état matrimonial ou tout autre statut protégé par la loi applicable.  Des mesures d’adaptation 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 d’adaptation, nous vous encourageons à contacter notre équipe d’acquisition de talents au [email protected], afin qu’IQVIA puisse soutenir votre participation au processus de recrutement.

IQVIA s’engage à faire preuve d’intégrité 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 d’emploi si elle est découverte ultérieurement, conformément aux lois applicables. Nous apprécions votre honnêteté et votre professionnalisme.

Veuillez noter qu'il est possible que nous utilisions l'intelligence artificielle (IA) dans le traitement de votre candidature. Cependant, nous utilisons l'IA 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 https://jobs.iqvia.com

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: [email protected], 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.

La fourchette salariale de base potentielle pour ce poste, annualisée, est de $84,000.00 - $140,000.00. Le salaire de base réel offert peut varier selon plusieurs facteurs, notamment les qualifications liées à l’emploi telles que les connaissances, les compétences, la formation et l’expérience; l’emplacement; et/ou l’horaire (temps plein ou temps partiel). Selon le poste offert, des régimes d’incitation, des primes et/ou d’autres formes de rémunération peuvent être proposés, en plus d’une gamme d’avantages sociaux liés à la santé, au bien-être et/ou d’autres bénéfices.

 

The potential base pay range for this role, when annualized, is $84,000.00 - $140,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and wellness and/or other benefits.