SMA (Study Management Associate) III
2 weeks ago
企業概要
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 in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.
求人内容Purpose
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 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. The Study Management Associate III is expected to work in accordance with all AbbVie Ways of Working.
This is a global role and may be located virtually.
Responsibilities
The Study Management Associate III is expected to work independently as a clinical study leader and contributor with appropriate support from the Study Project Manager on the following activities in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures):
• 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:
o 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)
o 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
o 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
o 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
o 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:
o 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
o CTMS and eTMF management to ensure compliance/inspection readiness, support trend analyses and support timelines
o 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
o 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
Qualifications
• Bachelor'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)
• 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
AbbVieは、誠実な事業運営、イノベーション推進、人々の生活の変革、地域社会への貢献、そしてダイバーシティ&インクルージョンの促進などに尽力しています。AbbVieの採用方針は、人種や肌の色、宗教、国籍、年齢、性別(妊娠を含む)、身体的・精神的障がい、病気、遺伝情報、性同一性または表現、性的指向、婚姻状況、退役軍人やその他法的に保護されたグループに属するかどうか等に関わらず、高い能力を持つ優秀人財を従業員や候補者として差別することなく雇用することです。
#J-18808-Ljbffr
-
Associate, Quality Services
2 weeks ago
Hamilton, Ontario, Canada Allergan Full timeAbbVie'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 aim to have a significant impact on people's lives across key therapeutic areas such as immunology, oncology, neuroscience, and eye care, as well as products and services in our Allergan...
-
Academic Department Manager Iii
2 weeks ago
Hamilton, Ontario, Canada McMaster University Full timeScheduleMonday - Friday, 8:30 am - 4:30 pm.Education LevelMaster's level degree in a relevant field, or a professional designation, such as a CPA.Career Level5-10 years of managerial experience.About the School of Interdisciplinary ScienceThe School of Interdisciplinary Science (SIS), based in the Faculty of Science, is seeking a dynamic administrative...
-
Instrument and Electrical Technician III
2 weeks ago
Hamilton, Ontario, Canada Omega Project Solutions Full timeInstrument and Electrical Technician III NSM Omega is searching for an Instrument and Electrical Technician III for our MAJOR oil & Gas Client in ON. ASSIGNMENT DESCRIPTION Installs and maintains electrical and instrument equipment in compliance with all rules and practices. Tests and repairs electrical and instrumentation systems utilized by...
-
Data Management Assistant(Iii)
2 weeks ago
Hamilton, Ontario, Canada McMaster University Full timeScheduleMonday-Friday 8:30-4:30, 35 hours/weekEducation Level2 year Community College diploma in Office Administration or related field.Career LevelRequires a minimum of 3 years of relevant experience.JD #JD00435Pay Grade:6Title:Data Management Assistant (III)Unit/Project Description:The Undergraduate Medical Education (UGME) Program is a three-year,...
-
Professor, Indigenous Studies
1 week ago
Hamilton, Ontario, Canada Mohawk College Full timeProfessor, Indigenous Studies Status**:Full TimeHours: Monday to Friday; 8:00am to 10:00pmHome Campus: FennellPayband: Not applicableSalary Range: Commensurate with qualifications and experiencePosting Date: April 11th, 2023Closing Date: Open until filledWe support and encourage the contributions of our diverse employees. In partnership with Indigenous...
-
Teaching & Learning Librarian - Graduate Studies
2 weeks ago
Hamilton, Ontario, Canada McMaster University Full timeScheduleMonday to Friday, 9:00 am to 5:00 pmEducation LevelMaster's DegreeCareer LevelLevel I or IIGENERAL RESPONSIBILITY:The Teaching and Learning Librarian, Graduate Studies will collaborate with Teaching and Learning Division staff and other Library and campus partners to advance the teaching and learning mission of the Library. They will design, deliver...
-
Academic Department Manager Iii
1 week ago
Hamilton, Ontario, Canada McMaster University Full timeScheduleMonday - Friday, 8:30am - 4:30pm.Education LevelMaster's level degree in a relevant field or a professional designation such as a CPA.Career Level5-10 years of managerial experience.About the School of Earth, Environment & SocietyThe School of Earth, Environment & Society (SEES) is a large department within the Faculty of Science, focusing on...
-
Cash Management Officer Iii
2 weeks ago
Hamilton, Ontario, Canada TD Bank Full timeCash Management Officer III - National Real Estate Group:BRJob Category - Primary Commercial BankingWork Location 100 King Street W Hamilton CorporateEmployment Type RegularCity HamiltonTime Type Full TimeProvince/State OntarioHours 37.5Workplace Model OnsitePay DetailsDepartment Overview The National Real Estate Group (NREG) is a highly specialized segment...
-
Research Coordinator
2 weeks ago
Hamilton, Ontario, Canada McMaster University Full timeScheduleMonday - Friday 8:30 - 4:30Education LevelMaster's degree in a relevant field of study.Career LevelRequires 5 years of relevant experience.JD # JD00440Pay Grade: 10Title: Research Coordinator (III)Unit/Project Description:This position will require working collaboratively with an interdisciplinary team of researchers and project staff led by the...
-
Hamilton, Ontario, Canada Allergan Full timeAssistant (or Associate) Medical Director, Oncology Japan Development AbbVie is committed to discovering and delivering innovative medicines to address serious health issues both now and in the future. Our goal is to make a significant impact on people's lives in various essential therapeutic areas, including immunology, oncology, neuroscience, and eye care,...
-
Hamilton, Ontario, Canada Allergan Full timeAssistant (or Associate) Medical Director, Oncology Japan Development AbbVie is committed to discovering and delivering innovative medicines to address serious health issues both now and in the future. Our goal is to make a significant impact on people's lives in various essential therapeutic areas, including immunology, oncology, neuroscience, and eye care,...
-
General Labourer/Bin Painter
2 weeks ago
Hamilton, Ontario, Canada Waste Management Full timeStarting Pay: $26.18/hr Shift: M-F. Summer 7am – 3pm. Winter 5am-1pm (Only candidates with currently valid Canadian social insurance numbers will be As an EEO/Affirmative Action Employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age,...
-
Research Lab Technician
2 weeks ago
Hamilton, Ontario, Canada McMaster University Full timeSchedule37.5 hours per week. 7.5 hours per day, Monday to Friday, 8am to 4:30pmEducation LevelBachelor's Degree in a relevant field of studyCareer Level2 years experienceJD #JD00620Pay Grade:7Title:Research Laboratory Technician (III)Unit/Project Description: For Department use only._Reporting to the Canada Research Chair in Human Cancer Stem Cell Biology,...
-
Maintenance Technician III, Electrician
2 weeks ago
Hamilton, Ontario, Canada Allergan Full timeAbbVie'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...
-
Administrative Assistant
1 week ago
Hamilton, Ontario, Canada McMaster University Full timeScheduleMonday - Friday; 8:30 AM - 4:30 PMEducation Level2 year Community College diploma in Office Administration or related field of study.Career LevelRequires 4 years of relevant experience.Aministrative AssistantJD#: JD00643Project Description:The School of Nursing requires an Administrative Assistant (III) to provide administrative support to the...
-
Research Associate
2 weeks ago
Hamilton, Ontario, Canada McMaster University Full timeScheduleMonday - Friday, 8:30am - 4:30pm (Hybrid schedule)Education LevelPhD in relevant field of studyCareer LevelRequires 5 years of relevant experience.PROJECT DESCRIPTION:Located in the DeGroote School of Business, at the Ron Joyce Center in Burlington, the McMaster Digital Transformation Research Centre (MDTRC) is designed as a knowledge hub to engage...
-
Associate Dentist
1 week ago
Hamilton, Ontario, Canada dentalcorp Full timeWe are looking for a highly motivated Associate to join our ever-growing well-established practice in Hamilton. The selected associate will be confident performing Endodontics, Crown & Bridge, and most Extractions.About us: We are looking for a highly motivated experienced Associate to join our busy well established practice located in Hamilton ON.Our fully...
-
Associate Dentist
1 month ago
Hamilton, Ontario, Canada dentalcorp Full timeWe are looking for a highly motivated Associate to join our ever-growing well-established practice in Hamilton. The selected associate will be confident performing Endodontics, Crown & Bridge, and most Extractions.About us: We are looking for a highly motivated experienced Associate to join our busy well established practice located in Hamilton ON.Our fully...
-
Associate Dentist
4 weeks ago
Hamilton, Ontario, Canada dentalcorp Full timeWe are looking for a highly motivated Associate to join our ever-growing well-established practice in Hamilton. The selected associate will be confident performing Endodontics, Crown & Bridge, and most Extractions.About us: We are looking for a highly motivated experienced Associate to join our busy well established practice located in Hamilton ON.Our fully...
-
Laboratory Technician Iii
2 weeks ago
Hamilton, Ontario, Canada McMaster University Full timeSchedule37.5 Hours per week, Monday to Friday 8:30am - 5:00pm.Education LevelBachelor's degree in a relevant field of study.Career LevelRequires 2 years of relevant experience.Unit/Project Description:Ongoing research at the Choe lab at McMaster University aims to understand how autism spectrum disorder (ASD)-risk gene mutations lead to its behavioural...
