Clinical Operation Manager, SSU

Responsibilities:
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
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
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
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
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
Liaison coss-functional staff on use of templates and systematic processes for study start up
Track progress against study start up timelines and milestones and escalate risks to CCOM and Senior COM
Support development of mitigation plans for identified risks and assist with plan execution across applicable functional areas
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
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
Lead development of HGRAC strategic and implementation plans for accelerated SSU and site activation.
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.
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.
Responsible for the acquisition and retention, performance management, and growth and development of talent.
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:
At least 2 years experience as a people manager or project manager
CRA background and knowledgeable for the life cycle of clinical trials.
Familiar with SSU activities
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

Skills
Onboarding, Documentation

Employment type
Full-time

Work arrangement
Yes