Study Management Associate III/Study Project Manager I, Oncology Clinical Operations

Employer
AbbVie
Location
South San Francisco, California, USA
Posted
May 23, 2018
Ref
1803854
Required Education
Associate Degree
Position Type
Full time
AbbVie is expanding its oncology hub on the West Coast, with three sites in the San Francisco Bay Area (Redwood City, South San Francisco, and Sunnyvale) focused on the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work across these three sites. They 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. This position is based at Stemcentrx, AbbVie's South San Francisco, CA location.

The Study Project Manager is responsible to connect science and operations to bring clinical studies to life through the execution of one or more Phase 1-4 clinical research studies. Contributes clinical operational strategies to ensure clinical research studies are executed with quality and efficiency, on-time, within budget, and meet company objectives. The study project manager achieves these objectives via scientific expertise, strategic thinking, a global mindset and innovative solutions to address risks and challenges.


Key Responsibilities Include:

  • 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: o Leads Clinical Study Team Meetings o 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

Basic:

  • Bachelor's Degree or equivalent is required, typically in nursing or scientific field; Associate's Degree, R.N., or equivalent with relevant experience is acceptable.
  • Must have at least 6 years of Pharma-related/clinical research related experience.
  • Demonstrates a high level of core and technical competencies through management of various components of clinical trials.
  • Possesses good communication skills and demonstrated leadership abilities.
  • Demonstration of successful coaching/mentoring in a matrix environment.
  • Competent in application of standard business procedures (Standard Operating Procedures, International Conference on Harmonization (ICH), Global Regulations, Ethics and Compliance).
  • Preferred exposure in study initiation through study completion in multiple phases of studies (Phase 1-3, 4).

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Posting Grade:

Grade: 18
Job Grades are determined by the country in which the payroll is based