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AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Sr. Manager, Area Study Start Up (Europe))

United Kingdom Req ID 2203979 Category Clinical Research Division AbbVie

Job Title: Manager, Area Study Start Up (WEC and EEMEA)

Purpose: The Sr. Manager, Area Study Start Up is responsible and accountable for line-management, operational-management and career-development of WEC+EEMEA ASSUL Team, and ultimately for on-time, budget and quality delivery and execution of the start-up and maintenance activities of the assigned Clinical Development Operations managed pipeline within Area. The role reports into the Area SSU Head and serves as a single point of accountability across WEC and EEMEA Areas for the ASSUL team delivery and development.

Note: In WEC and EEMEA, ASSULs will report in through the Sr. Manager, Area Study Start Up, who reports to the Area SSU Head.

Primary responsibilities include but not limited to:

  • Line manager for Area SSU Leads and responsible for their growth and development;
  • Accountable for managing resourcing, hiring, performance reviews and talent development for designated Area SSU staff;
  • Provide support and functional training on start up strategies, establishing country/site activation plans, start-up timelines, site profiles as well as risks assessment and mitigation planning for the Area;
  • Drive maintenance of country and site intelligence for assigned Area;
  • Provide Area start-up updates and metrics to Area Director, Area SSU Head, Global SSU Leads;
  • Lead Area quality management through risk-based thinking;
  • Drive a learning environment (best practice sharing, and lessons learned) and ensure continuous improvement in Area/country performance by using innovative approaches, active analysis of Key Risk and Performance Indicators, metrics, milestones, and benchmarking;
  • Manage identified risks to start-up through development of effective mitigation plans;
  • Ensure audit/inspection readiness at all times and compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines;
  • Work collaboratively with the Area SSU Head and Area SSU COMs to:
    • Implement resourcing and training strategies in response to changes affecting Area, including effective organizational change management;
    • Deliver consistent best practice approach to onboarding (incl. for Country Start-up Specialists) and defining best practice training curriculum for the SSU roles;
  • Lead simplicity in process and approach, and enhance agility, including leading Area training and development of SOPs, job aids and work instructions in collaboration with other Area SSU-related roles;
  • Consolidate “lessons learned” across Areas and incorporating into SSU training materials;
  • Work collaboratively and partner with all key stakeholders to facilitate cross-functional communication and collaboration;
  • Participate in process improvement initiatives as required.

Qualifications:

  • Bachelor's Degree, degree in health care or scientific field required;
  • Minimum of 8 years of clinical research experience, preferably with 4+ years of relevant study start-up management experience;
  • Minimum of 2 years of experience in line-management of people including acquisition of talent, performance management, growth and development, managing employee relations, coaching and mentoring of staff and teams;
  • Ability to work independently without significant oversight;
  • Proven leadership skills in a cross-functional global team environment, experience in managing remote/virtual teams, and an ability to influence and align stakeholders, while modeling and driving AbbVie’s leadership attributes;
  • Strong analytical and critical thinking skills and the ability to evaluate complex issues from multiple perspectives and drive smart decision making. Interpersonal skills with the ability to build trust and communica

     


Qualifications:

  • Bachelor's Degree, degree in health care or scientific field required;
  • Minimum of 8 years of clinical research experience, preferably with 4+ years of relevant study start-up management experience;
  • Minimum of 2 years of experience in line-management of people including acquisition of talent, performance management, growth and development, managing employee relations, coaching and mentoring of staff and teams;
  • Ability to work independently without significant oversight;
  • Proven leadership skills in a cross-functional global team environment, experience in managing remote/virtual teams, and an ability to influence and align stakeholders, while modeling and driving AbbVie’s leadership attributes;
  • Strong analytical and critical thinking skills and the ability to evaluate complex issues from multiple perspectives and drive smart decision making. Interpersonal skills with the ability to build trust and communicate persuasively and with clarity, flexibility and adaptability to changing requirements;
  • Demonstration of successful program execution, preferably in start-up, and aptitude for managing multiple priorities in a fast‐paced environment;
  • Demonstration of participating in successful initiatives, special projects, and activities that support the business;
  • Advanced working knowledge of ICH and GCP guidelines and operational understanding of the global regulatory environment.
Travel: Yes, 5 % of the Time
Job Type: Experienced
Schedule: Full-time
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