Study Project Manager II

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)