Clinical Operation Manager, SSU

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Responsibilities:

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

1. 1. Support CSM staff in start up activities such as (but not limited to) country and site feasibility, site selection, site activation, etc. by interfacing with various functional areas
   2. Support CCOM, Senior COM and other functional areas to develop and support implementation of a proactive Country Approval and Site Activation Plans for targeted studies including performing critical path analyses to identify and remove obstacles and minimize lag times between key activities
   3. Support the strategy and development surrounding country and site activation planning inclusive of IRB/EC submissions; site document collection; site contracting; etc. via collaborative partnerships with the Clinical Documentation Center, CSM, local Regulatory, Legal, Outsourcing/Contract Management
   4. Collect and analyze AbbVie and industry (as available) benchmarking data across assigned disease areas/indications in support of development and implementation of strategic start up plans
   5. Liaison coss-functional staff on use of templates and systematic processes for study start up
   6. Track progress against study start up timelines and milestones and escalate risks to CCOM and Senior COM
   7. Support development of mitigation plans for identified risks and assist with plan execution across applicable functional areas
   8. Contribute to lessons learned sessions at appropriate intervals and incorporate, as applicable, into processes moving forward, sharing across functional groups/therapeutic areas. Provide expertise on best practices for country and site activation
   9. Support development and implementation of country approval and site activation initiatives to meet global regulatory requirements, maintain alignment with clinical program timelines to achieve business objectives, and support other initiatives for the business as needed
   10. Lead development of HGRAC strategic and implementation plans for accelerated SSU and site activation.
   11. Accountable for resource management for assigned team. Provide ongoing assessment and input towards resource needs and in allocating resources in alignment with AbbVie research goals, priorities, and specific study timelines. Proactively identify and communicate issues impacting resource allocation and provide solutions.
   12. Accountable for resource management and deliverables of the assigned CSSU team. Collaborate with key stakeholders to ensure appropriate study specific training and assignment of assigned staff to studies and sites. Responsible for the direct/functional management, as applicable, of the assigned CSSUs including hiring, onboarding, training, task assignment, mentorship, performance management, and growth and development.
   13. Responsible for the acquisition and retention, performance management, and growth and development of talent.
   14. Responsible for identifying training needs and standardizing and facilitating training solutions for CSSU. Provide consistent best practice approach to onboarding, consolidating “lessons learned” across areas and incorporating into SSU training materials, defining best practice training curriculum, and maintaining awareness of upcoming changes to ensure effective training is delivered in a timely manner.

Qualifications:

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

• Education: Bachelor OR Master Degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred.
• Working experience:
  1. At least 2 years experience as a people manager or project manager
  2. CRA background and knowledgeable for the life cycle of clinical trials.
  3. Familiar with SSU activities
  4. Familiar with HGRAC management
• Having strong personality of result driven.
• Must be able to understand the global environment from an operations as well as from a cultural perspective
• Must have experience building effective working relationships across functions and geographic locations
• Strong analytical, strategic, and critical thinking skills to obtain the appropriate data/information and
• evaluate complex issues from multiple perspectives to drive smart decision making. Excellent interpersonal
• skills with the ability to influence without authority, communicate with clarity, demonstrate flexibility,
• adaptability to changing requirements, resourcefulness and creativity
• Demonstration of successful execution of projects in a fast-paced environment managing multiple priorities
• Ability to use multiple technologies for communication purpose

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

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

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