Senior Manager, Global Study Start-Up Maintenance Intercontinental

Company 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 in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

AbbVie is an equal opportunity employer, and dedicated to fostering an inclusive, flexible, and supportive workplace that values and respects every individual. We are committed to operating with integrity, driving innovation, transforming lives, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability. We ensure a fair and inclusive recruitment process without discrimination against any employee or applicant because of, and not limited to, race, religion, age, physical or mental disability, gender identity or expression, sexual orientation, or marital status. Our hiring process is flexible and accessible, so if you have any specific requests or accessibility requirement, please feel comfortable to let our team know by emailing [email protected] or speaking with your Recruiter and we'll make any necessary adjustments to accommodate your needs.

Job Description

The Senior Manager, Global Study Start Up Maintenance Intercontinental is responsible and accountable for line-management, operational-management and career-development of the Intercontinental Area Start Up Lead (ASUL) team assigned to Study Start Up Maintenance, 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 the Area. The role reports into the Associate Director, Study Start Up or Director, Study Start Up and serves as a single point of accountability across the Area for the ASUL team delivery and development

KEY DUTIES AND RESPONSIBILITIES

Responsibilities

• Responsible for the growth and development of the ASUL team 
• Accountable for managing resourcing, hiring, performance reviews and talent development for designated Area Study Start Up
• Providing start-up focused strategic input on activities that may occur in the maintenance phase of a study on the global/area and country strategy as applicable, start-up and additional submission timelines, site profiles and risk assessment for Global/Area
• Establishing country/site amendment strategy plans and/or activation plans including risk assessments and mitigation planning for Global/Area
• Driving maintenance of country and site intelligence globally or assigned area
• Monitoring global/area start-up maintenance performance and reporting on metrics
• 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 and maintenance 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, Area Managers, Area SSU COMs, and Area COMs overseeing SSU activities to:
  o Implement resourcing and training strategies in response to changes affecting Area, including effective organisational change management
  o Deliver consistent best practice approach to onboarding 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 material
• Working collaboratively and partnering with all key stakeholders to facilitate cross-functional communication and collaboration
• Participating in or leading cross-functional process improvement initiatives or special projects as required

Qualifications

• Bachelor's Degree in Health Care or Scientific Field required
• 8+ years of clinical research experience, preferably with 4+ years of relevant study start-up management experience
• 2+ years of experience in line-management of people (preferred) 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

Flexibility and Availability: In line with Australia’s 'Right to Disconnect' legislation, we recognise and respect employees' right to refuse contact outside of their working hours, unless such refusal is deemed unreasonable. As we operate in an international, matrixed environment, there may be occasions where your role requires participation in business meetings outside of standard hours. We value and support flexibility and appreciate your willingness to occasionally accommodate these requests to ensure effective collaboration and communication within our global team.

Additional Information

AbbVie is an equal opportunity employer and 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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html 

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