Study Project Manager II, Study Management & Execution
AbbVie
1 month ago
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Responsibilities:
- Plan, manage, and execute MHI non-interventional studies in compliance with quality standards (Global Regulations, AbbVie policies and procedures).
- Partner with Medical TA and V&E to develop study protocol and associated documents (e.g., informed consent forms, case report forms, Clinical Study Report, publications).
- Lead cross-functional study team: lead study meetings, manage the critical path, work with Affiliates, and ensure milestones are met.
- In partnership with the MHI study lead, handle study-level vendor selection, define vendor activity scope, and oversee vendors to ensure compliance (e.g., data management, medical writing).
- Generate study-related training for study team members, study sites, and selected vendors (as applicable).
- Provide regular study status updates to cross-functional teams and stakeholders; ensure CTMS entries are complete/accurate and documents are filed in the Trial Master File (TMF).
- Proactively identify, address, and/or escalate study issues; connect with TA-aligned EP&E Program Directors as needed.
- Manage study budget and spend against approved budget with V&E Operations.
- Ensure inspection readiness and participate in inspection/audit activities.
- Lead continuous improvement activities/projects with Business Excellence (as appropriate).
- Contribute to team culture (information sharing, team building, mentoring junior staff).
- May provide direct supervision to AbbVie employees and/or oversee contractors.
Qualifications:
- Bachelor’s degree or international equivalent required; scientific degree preferred.
- 8+ years pharmaceutical industry-related experience (or 6 years with an advanced degree).
- Competent in standard quality procedures (SOP, ICH/GCP, Local Regulations).
- Strong core/technical competencies managing clinical/medical study components.
- Proven presentation and communication skills.
- Proven organizational, project management, and leadership skills; facilitate cross-functional meetings.
- Proven analytical/critical thinking; solve problems at operational and tactical levels.
- Operate independently; escalate issues with proposed action/mitigation plan.
- Capable of meeting changing business and regulatory requirements.
- Coaching/mentoring experience in a matrix environment; direct people management desirable.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
Application instructions:
- Applicants seeking a reasonable accommodation (US & Puerto Rico) should use the provided link: https://www.abbvie.com/join-us/reasonable-accommodations.html
- Plan, manage, and execute MHI non-interventional studies in compliance with quality standards (Global Regulations, AbbVie policies and procedures).
- Partner with Medical TA and V&E to develop study protocol and associated documents (e.g., informed consent forms, case report forms, Clinical Study Report, publications).
- Lead cross-functional study team: lead study meetings, manage the critical path, work with Affiliates, and ensure milestones are met.
- In partnership with the MHI study lead, handle study-level vendor selection, define vendor activity scope, and oversee vendors to ensure compliance (e.g., data management, medical writing).
- Generate study-related training for study team members, study sites, and selected vendors (as applicable).
- Provide regular study status updates to cross-functional teams and stakeholders; ensure CTMS entries are complete/accurate and documents are filed in the Trial Master File (TMF).
- Proactively identify, address, and/or escalate study issues; connect with TA-aligned EP&E Program Directors as needed.
- Manage study budget and spend against approved budget with V&E Operations.
- Ensure inspection readiness and participate in inspection/audit activities.
- Lead continuous improvement activities/projects with Business Excellence (as appropriate).
- Contribute to team culture (information sharing, team building, mentoring junior staff).
- May provide direct supervision to AbbVie employees and/or oversee contractors.
Qualifications:
- Bachelor’s degree or international equivalent required; scientific degree preferred.
- 8+ years pharmaceutical industry-related experience (or 6 years with an advanced degree).
- Competent in standard quality procedures (SOP, ICH/GCP, Local Regulations).
- Strong core/technical competencies managing clinical/medical study components.
- Proven presentation and communication skills.
- Proven organizational, project management, and leadership skills; facilitate cross-functional meetings.
- Proven analytical/critical thinking; solve problems at operational and tactical levels.
- Operate independently; escalate issues with proposed action/mitigation plan.
- Capable of meeting changing business and regulatory requirements.
- Coaching/mentoring experience in a matrix environment; direct people management desirable.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
Application instructions:
- Applicants seeking a reasonable accommodation (US & Puerto Rico) should use the provided link: https://www.abbvie.com/join-us/reasonable-accommodations.html