Associate, Study Management Iii
hace 2 semanas
Company DescriptionAbbVie'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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.
For more information about AbbVie, please visit us at www.Abbvie.Com.
Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.Job DescriptionSMA IIIAs a Study Management Associate III, you will be part of a dynamic, centralized study management team that is responsible for the execution of our global clinical trials and a key member of the study team.
The Study Management Associate III works as an independent, contributing member of a cross-functional and global partnership to plan, execute and manage one or more Phase 0-4 clinical trials under the guidance of the Study Project Manager and SMA Manager.
The Study Management Associate III works to ensure that assigned studies are executed with quality and efficiency, in accordance with timelines and budget to support broader company strategic objectives.Primary responsibilities:Study-level oversight and leadership of one or more global trials in a cross-functional environment for activities from inception through closure, connecting functional work and strategic work across the global study, including but not limited to:Supports the Study Project Manager in strategic leadership of the cross-functional team through stakeholder engagement and influence to drive deliverables and timelines, including strategy development, meeting facilitation, and timely documentation at the study level to drive for timely execution of clinical trial(s).Vendor management, including Request for Proposal (RFP)/initiation, selection, Scope of Work development & review, deliverable oversight, and risk management for one or more external vendors, e.G., central lab, recruitment, imaging, internal and external committees.Recruitment management, including thoughtful review of intelligence data, leadership, cross-functional development, and execution of recruitment strategies and mitigation planning on a global scale from country feasibility through subject recruitment and retention.Leadership of assigned meetings (cross-functional (internal), vendor, and/or investigator) and provision of regular updates on study status, e.G., agenda development, minutes curation and filing.Ensure inspection readiness and participate in related activities.Risk identification, mitigation, and management, including timely issue review, escalation, and management to support trend analysis and risk prevention.Co-development and management (review, revision, tracking and filing) of study materials, including but not limited to: Protocols, regulatory submissions, patient reported outcome measures, study execution plan, informed consent, site budgets and agreements, clinical study report, training materials, newsletters, presentations for various stakeholders.CTMS and eTMF management to ensure compliance/inspection readiness, support trend analyses and support timelines.EDC, IRT, and ePRO, which includes review of design specifications, participation in user acceptance testing, and contribution to development and review of associated plans and key risk indicators, as well as system management activities like access support, query resolution, and oversight.Management of investigational product and other associated study supplies.Provide engaging training to identified stakeholders as needed, e.G., study team members, vendors.Support global submission strategies.Support process improvement initiatives or serve as a subject matter expert and/or mentor.QualificationsBachelor's Degree or OUS equivalent required.Must have at least 4 years of progressive Pharma-related/clinical research-related experience with a high level of core and technical competencies.Competent in application of standard quality procedures (SOP, ICH/GCP, Global Regulations) and experienced user of systems such as EDC, IRT, CTMS, and eTMF.Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives to actively develop strategies and drive smart decision making to support acceleration of study timelines and enable a well-run study.Excellent organizational and time management skills, strong attention to detail.Exceptional interpersonal skills with ability to communicate effectively in a clear and persuasive manner in a global setting; proficient in business/technical English-language (oral and written).Proactive, collaborative mindset.Ability to work independently in a fast-paced global team environment.Preferred: Exposure to study initiation through completion activities; global study exposure.Additional InformationAbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.
It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.#J-18808-Ljbffr
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Associate, Study Management Iii
hace 1 mes
Madrid, España Abbvie A tiempo completo.Company DescriptionAbbVie'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 – immunology, oncology, neuroscience, and eye care – and products and...
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Associate, Study Management Iii
hace 4 meses
Madrid, España AbbVie A tiempo completo**Company Description** **Job Description** SMA III** As a Study Management Associate III, you will be part of a dynamic, centralized study management team that is responsible for the execution of our global clinical trials and a key member of the study team. The Study Management Associate III works as an independent, contributing member of a...
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Associate, Study Management Iii
hace 1 mes
Madrid, España Abbvie A tiempo completoCompany Description AbbVie'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 – immunology, oncology, neuroscience, and eye care – and products and...
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Associate, Study Management Iii
hace 1 mes
Madrid, España Abbvie A tiempo completoCompany Description AbbVie'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 – immunology, oncology, neuroscience, and eye care – and products and services...
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Associate, Study Management Iii
hace 2 semanas
Madrid, España Abbvie A tiempo completoCompany DescriptionAbbVie'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 – immunology, oncology, neuroscience, and eye care – and products and services...
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Study Management Associate III
hace 3 semanas
Madrid, Madrid, España Abbvie A tiempo completoJob DescriptionJob Summary: We are seeking a highly skilled and experienced Study Management Associate III to join our dynamic and centralized study management team at AbbVie. As a key member of the study team, you will be responsible for the execution of our global clinical trials and will work closely with cross-functional partners to plan, execute, and...
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Study Management Associate III
hace 3 semanas
Madrid, Madrid, España Abbvie A tiempo completoJob DescriptionJob Summary: We are seeking a highly skilled and experienced Study Management Associate III to join our dynamic and centralized study management team at AbbVie. As a key member of the study team, you will be responsible for the execution of our global clinical trials and will work closely with cross-functional partners to plan, execute, and...
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Study Management Associate III
hace 3 semanas
Madrid, Madrid, España AbbVie A tiempo completoAbout the RoleWe are seeking a highly skilled and experienced Study Management Associate III to join our dynamic and centralized study management team at AbbVie. As a key member of the study team, you will be responsible for the execution of our global clinical trials and will work closely with cross-functional partners to plan, execute, and manage Phase 0-4...
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Study Management Associate III
hace 3 semanas
Madrid, Madrid, España AbbVie A tiempo completoAbout the RoleWe are seeking a highly skilled and experienced Study Management Associate III to join our dynamic and centralized study management team at AbbVie. As a key member of the study team, you will be responsible for the execution of our global clinical trials and will work closely with cross-functional partners to plan, execute, and manage Phase 0-4...
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Clinical Research Associate III
hace 2 semanas
Madrid, Madrid, España Abbvie A tiempo completo{"title": "Study Management Associate III", "description": "Job SummaryAbbVie is seeking a highly skilled Study Management Associate III to join our dynamic, centralized study management team. As a key member of the study team, you will be responsible for planning, executing, and managing global clinical trials under the guidance of the Study Project Manager...
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Clinical Research Associate III
hace 2 semanas
Madrid, Madrid, España Abbvie A tiempo completo{"title": "Study Management Associate III", "description": "Job SummaryAbbVie is seeking a highly skilled Study Management Associate III to join our dynamic, centralized study management team. As a key member of the study team, you will be responsible for planning, executing, and managing global clinical trials under the guidance of the Study Project Manager...
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Madrid, Madrid, España ICON A tiempo completoJob Summary:ICON is seeking a highly skilled and experienced Study Start Up Associate II to join our dynamic team. As a Study Start Up Associate II, you will play a pivotal role in leading the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of innovative treatments and therapies.Key...
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Madrid, Madrid, España ICON A tiempo completoJob Summary:ICON is seeking a highly skilled and experienced Study Start Up Associate II to join our dynamic team. As a Study Start Up Associate II, you will play a pivotal role in leading the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of innovative treatments and therapies.Key...
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Madrid, Madrid, España Icon A tiempo completoAbout the Role**Study Start Up Associate II**We are seeking a highly skilled and experienced Study Start Up Associate II to join our team at ICON. As a key member of our clinical trials team, you will play a pivotal role in leading the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of...
