Specialist, Country Study Start Up

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 at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 

Purpose: The Specialist, Country SSU proactively drives and executes all start up and maintenance related activities and deliverables for assigned studies and sites in their assigned country or countries.

Note: Specialists will report into their local country COM but have an operational reporting line to Area and Global SSU Leads

Primary responsibilities include but not limited to:
• Ensure successful and on time and quality execution of start-up and maintenance activities for assigned sites and studies; site assignment scope primarily central IRB/EC sites
• Establish the country/site activation plans and priorities including risk assessment and mitigation plans with CCOM/COM, Area SSU and CSM Lead, Contract Manager, CTS/Regulatory Affairs
• Proactively identify and communicate issues impacting delivery and providing proposed solutions.
• Attend regional/area start up calls and providing input for assigned sites/studies
• Collection of essential documents from sites and completing quality check (ALCOA)
• Compile and submit ethics and other required local submissions including customization of ICFs, patient facing materials and safety reporting
• Coordinate with Regulatory and CTS on CA submission and approval status to assure alignment with other site activation requirements
• Collaborate with contract manager, CRA, Area CSM Lead as required to assure timely site activation
• Reviewing site and/or IRB/EC comments on ICFs and routing for approval by required functional areas
• Trigger clinical supply shipments
• Complete IP release activities and triggering IP shipment
• Issue site green light letter and activating sites in IXRS
• Track all start up and maintenance related activities in Vault SSU as appropriate
• Maintain local country and site intelligence database and EDLs in Vault.
• Maintain SSU performance metrics and KPIs for assigned sites/studies.
• Provide start up updates and metrics to CCOM/COM and Area SSU and CSM Leads
• Ensure audit/inspection readiness
• Ensure compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines
• Participate in process improvement initiatives as required

Qualifications:

• Bachelor's Degree (degree in health care or scientific field) highly preferred or equivalent years of experience required

• A minimum of 1-2 years of clinical research experience and preferably 1+ years of study start up management experience for the designated region.

• Experience working with remote/virtual teams

• Strong analytical and critical thinking skills and the ability to evaluate complex issues from multiple perspectives.

• Strong interpersonal skills with the ability to build trust and communicate with clarity, flexibility and adaptability to changing requirements.

• Demonstration of successful execution, preferably in start up, and aptitude for managing multiple priorities in a fast‐paced environment

• Working knowledge of ICH and GCP guidelines and operational understanding of the country's regulatory environment

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。