Study Project Manager Ii
Vor 2 Tagen
**About AbbVie**
Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.
Our research scientists, clinicians, marketing, operations, and corporate professionals combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.
**Key Accountabilities/Core Job Responsibilities**
- 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 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
**Education/Qualifications**
- Bachelor’s Degree or OUS equivalent degree is required, typically in nursing or scientific field; registered Nurse licensure with Associate’s Degree in Nursing with relevant experience is acceptable.
- Must have at least 8 years of Pharma-related/clinical research related experience.
- Must have demonstrated a high level of core and technical competencies through management of clinical trials.
- Possess good communication skills and demonstrated leadership abilities.
- Demonstration of successful coaching and mentoring in a matrix environment; direct people management preferred.
- Experience in successful study initiation through study completion, primary data analysis and/or in multiple phases of studies (Phase 1-3, 4).
**Equal Employment Opportunity
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