Study Project Manager II (Remote)

Job Description
Responsible for executing clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures).
Leader of the cross functional study team; Leads Clinical Study Team Meetings; Project manager for clinical studies leveraging the clinical schedule; manages the critical path and milestones
Responsible for regular updates to the cross-functional team and stakeholders on study status; ensures our CTMS is up to date Responsible for regular updates to the cross-functional team and stakeholders on study status; ensures our CTMS is up to date
Responsible for the development of the clinical study design and associated systems and documents (for example: Informed consent forms, eCRFs, IRT, CSR)
Responsible for study budget creation and oversight of spend against approved budget
Responsible for the vendor selection, scope development, management and oversight of external vendors in compliance with AbbVie’s processes and procedures and the applicable regulations
Responsible for generating the study related training for the study team, study sites, and vendors for assigned studies
Proactively identify and address and/or escalate study related issues and opportunities for efficiency
Decision maker on operational aspects of study execution
Participates in innovation and process improvement initiatives
Provides direct supervision of study management associate(s) including career development of clinical operations staff and creating an inclusive and innovative environment where staff and studies/programs will succeed
  
 
 
 
 
 
 
 
 
Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)