Τελευταίες πληροφορίες εργασίας από IQVIA για τη θέση Senior Manager, Clinical Scientist. If the Senior Manager, Clinical Scientist κενή θέση σε Athens ταιριάζει με τα προσόντα σας, υποβάλετε την αίτηση ή το βιογραφικό σας απευθείας μέσω της ενημερωμένης πύλης εργασίας Jobkos.
Σημειώστε ότι η αίτηση για εργασία δεν είναι πάντα εύκολη, καθώς οι υποψήφιοι πρέπει να πληρούν συγκεκριμένες προϋποθέσεις. Ελπίζουμε η ευκαιρία καριέρας σε IQVIA για τη θέση Senior Manager, Clinical Scientist παρακάτω να ταιριάζει με τα προσόντα σας.
**Summary** As an Senior Manager , Clinical Scientist, you will play a critical role in leading and coordinating various clinical activities. You will work closely with physicians, subject matter experts, and a diverse set of stakeholders to drive clinical sections of documentation, manage timelines, contribute to study design, and ensure high-quality deliverables that meet internal and sponsor expectations. This role requires a seasoned professional capable of navigating complex problems and operating with minimal supervision. **Key Responsibilities** + Seasoned professional individual contributor that works independently with minimal supervision. Problems faced are sometimes complex. + Lead process for drafting clinical synopsis with Subject matter experts, coordinate with relevant stakeholders. + Leads review and contributes to review to Target Product Profile (TPP) clinical parameters, coordinate with relevant stakeholders. + Leads the review process and generates background information and provides contribution to CDP in collaboration with Physician and / or functional SME. + Manage timelines and clinical synopsis process including creating initial timelines, ensuring internal team and sponsor agreement, and update if required. + Identify relevant studies (completed or ongoing) in the literature or that IQVIA have previously run, and pull out key aspects that might be applicable to the current project. + Lead and manage the process in creating a study design, generate schematics of the design and highlight any variable for discussion, capture final design decisions, ensure internal team review prior to sharing with the sponsor. + Manage the study design process by creating a study design based on prior examples/literature searches. + Ensure the assigned physician reviews the design prior to sending it to the internal study team for review. + Get agreement of a study concept from the sponsor prior to drafting the synopsis. + Lead review and contribute to Synopsis Drafting process, coordinate with relevant stakeholders. + Create the initial draft using the appropriate template, ensure all internal team members are consulted as required, manage reviews according to the contract, reach out to internal team members to address comments, and lead comment resolution meetings with the sponsor. + Hand over synopsis to MW/regulatory if required. Confirm handover checklist has been Δημιουργήθηκε από MW, and review for accuracy. + Set up templates, coordinating with relevant contributors. + Prepare background slides based off directional guidance from PL and key contributors. + Lead the discussion with relevant stakeholders, summarize the findings, work with SMEs drafting risk/gap statement if needed. + Lead review and contribute to and review M2.73, 2.7.4 and 2.5 of the eCTD dossier, coordinate input from other disciplines; improve consistency and completeness across submissions. + Lead review and contribute to drafting clinical sections of introductions of any regulatory consultation briefing book and, where possible, Εταιρεία Θέσηing, coordinate with relevant stakeholders. + Support review and contribute to draft clinical responses to agency questions. + Lead review and contribute to the clinical sections of face to face slides for Advisory boards and regulatory agency meetings. **Qualifications** + Life Science PhD or MD (or equivalent) + Minimum 5 years of relevant clinical research or related industry experience. + **2 years and above experience in** **drafting clinical study synopsis and clinical sections of key regulatory documents (Must have).** + Experience in a drug development or pharmaceutical environment. + Familiarity with regulatory and sponsor interactions. + Demonstrated ability to design and implement complex clinical protocols. 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 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. At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes. Likewise, as part of this culture, IQVIA is committed to ensuring effective equality between women and men, integrating it as a strategic principle in its corporate and human resources policies. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. EEO Minorities/Females/Protected Veterans/Disabled
Πληροφορίες Εργασίας:
Εταιρεία: IQVIA
Θέση: Senior Manager, Clinical Scientist
Τοποθεσία Εργασίας: Athens
Χώρα: GR
Πώς να Υποβάλετε Αίτηση:
Αφού διαβάσετε και κατανοήσετε τα κριτήρια και τα ελάχιστα απαιτούμενα προσόντα που περιγράφονται στις πληροφορίες της θέσης Senior Manager, Clinical Scientist at the office Athens παραπάνω, συμπληρώστε άμεσα τα έγγραφα της αίτησής σας, όπως συνοδευτική επιστολή, βιογραφικό (CV), αντίγραφο πτυχίου και άλλα δικαιολογητικά. Υποβάλετε μέσω του συνδέσμου Επόμενη Σελίδα παρακάτω.
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