Sr. Study Management Specialist

Sr. Study Management SpecialistFull-timeWorkday Global Grade: 14Company DescriptionAbout AbbVieAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.Job DescriptionPURPOSEManage and Lead complex and high-priority studies on all aspects of design, planning, startup, conduct, analysis,reporting and closeout of assigned NIS including regulatory PMOS, IIS and PAA. Responsible for managing planning, timelines, milestone, budget, study sites, vendors and deliverables while maintaining quality and compliance.CORE JOB RESPONSIBILITIESProvide comprehensive input to study concept development especially from an operational, feasibility and study execution perspective.Develop and manage study documentation throughout the study lifecycle, including protocols, protocol amendments, CRFs, informed consent forms and CSRs, and coordinate required reviews, approvals and regulatory submissions, as applicable.Serve as the operational point of contact for MFDS for regulatory PMOS, including study-related communications and preparation of responses to supplementary requests regarding protocols, annual and final reports.Lead the end-to-end operational management of assigned studies from concept through final reporting, including study planning, timelines, milestones, issue resolution, stakeholder communication and delivery of study objectives.Lead study start-up activities and oversee vendor, CRO and study-site selection, set-up and performance to support timely and compliant study execution.Manage study budgets, forecasting, reconciliation, FMV assessments and investigator payments in accordance with applicable requirements.Manage PAA operations, including IP supply, importation and destruction; essential document development; applicable reviews, approvals and regulatory filings; and communication with MFDS, HQ, vendors and investigators.Provide operational oversight of IIS activities, including concept and protocol review, committee approvals, FMV assessments, contracting, milestone tracking, payment management and issue resolution.Act as a subject matter expert for study management processes including NIS, PMOS, IIS and PAA and Provide guidance and knowledge sharing to study team members.Contribute to continuous process improvement initiatives to enhance study quality, compliance and operational efficiency.Assure full compliance with GCP, Global & local SOPs, and Korean regulationsQualificationsUniversity degree or equivalent; preferably in a medical/science-related field or equivalent work experience in a scientific or health-related fieldMinimum 7-year experience in clinical research in healthcare, pharmaceutical and/or CRO industry orminimum 5-years’ direct experience as a project manager. Demonstrated experience independently managing complex studies is preferred.NIS experience is preferredFluent English communication skills (Reading, writing, speaking)Good understanding of clinical trial processes, AbbVie internal processes and the regulatory environment as well as strong knowledge of clinical research practices, local regulations, and ICH guidelinesFamiliarity with AbbVie policies & procedures and local SOPsStrong computer/technology skills including MS Word, MS Excel and PowerPointFluent English communication skills (Reading, writing, speaking)Possess strong project management, time management and coordination skills with goodorganizational, leadership, negotiation and interpersonal skillsStrong analytical and problem-solving capabilities with sense of responsibilityManage conflict, challenges, decision making and risk management as a project managerAbility to manage time/prioritize, multitask, work independently, self-motivated and follow through with assigned tasksExcellent written and verbal communication skills demonstrated by the ability to present clear messages from complex information/data to internal/external stakeholdersAdditional InformationCode of Conduct & Business IntegrityAbbVie is committed to observe high integrity and ethical standards in all its business dealings with our customers, with each other, business partners and suppliers.AbbVie as a responsible corporate citizen will adhere to these standards, as well as to local, national and international laws.AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.htmlUS & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:https://www.abbvie.com/join-us/reasonable-accommodations.htmlBy clicking the link above or any third-party link within this posting, you are leaving this site and going to a third-party website where the third-party website's terms and privacy policy applyI'm interestedI'm interestedPrivacy Notice