Purpose

Describe the primary goals, objectives or functions or outputs of this position.

As a Study Management Associate II, 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 II works as a 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 a Study Project Manager and SMA Manager. The Study Management Associate II 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 II is expected to work in accordance with all Abb Vie Ways of Working.

This is a global role and may be located virtually.

Responsibilities:

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

The Study Management Associate II is expected to work as a clinical study contributor with appropriate support from the Study Project Manager on the following activities in compliance with quality standards (ICH/GCP, Global Regulations, and Abb Vie policies and procedures):

• Study-level oversight and contribution to one or more global trials in a cross-functional environment for activities from inception through closure, including but not limited to:

• o Supporting the Study Project Manager and cross-functional team through stakeholder engagement and influence to drive deliverables and timelines, including meeting facilitation and timely documentation at the study and regional levels 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

• 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, 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 process improvement initiatives or serve as a subject matter expert and/or mentor

Qualifications:

List required and preferred qualifications (up to 10). Include education, skills and experience.

• Bachelor’s Degree or OUS equivalent required

• Must have at least 2 years of pharma/device or clinical research related experience, with a moderate level of core and technical competencies

• Competent in application of standard quality procedures (SOP, ICH/GCP, Global Regulations)- • Analytical and critical thinking skills to evaluate complex issues from multiple perspectives and contribute to strategy and 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.

• Strong interpersonal skills with ability to communicate effectively in a clear and persuasive manner; proficient in business/technical English-language (oral and written)

• Proactive, collaborative mindset• Ability to work independently in a fast-paced global team environment

• Preferred: Experience with 1 or more clinical trial systems (e.g., EDC, IRT, CTMS, eTMF); experience in 1 or more parts of a clinical trial

アッヴィは、機会均等を重視する雇用主であり、誠実な企業活動、革新の推進、人々の生活への貢献、そして地域社会への貢献に努めています。雇用機会均等に向けて、障がいを持つ方々も積極的に支援しています。

アッヴィの使命は、今日の深刻な健康問題を取り上げ、明日の医学的課題に対処する革新的な医薬品とソリューションを発見し、提供することです。免疫領域、腫瘍領域、神経科学領域、アラガン・エステティックスのポートフォリオに含まれる眼科領域など、複数ある主要治療領域や製品やサービスにおいて、人々の生活にめざましい効果を与えられるよう努力しています。Abb Vie の詳細については www.abbvie.com をご覧ください。ツイッター、フェイスブック、インスタグラム、YouTube、LinkedIn で @abbvie をフォローしてください。