Study Project Manager II, Clinical Operations - South San Francisco, CA | Biospace
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Study Project Manager II, Clinical Operations

AbbVie Stemcentrx

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Location:
South San Francisco, CA
Posted Date:
8/17/2017
Position Type:
Full time
Job Code:
1608162
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products — Imbruvica, Venclexta, and Empliciti — and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer.


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 will be based at Stemcentrx, AbbVie's South San Francisco, CA location.





As part of a talented and multi-disciplinary team advancing an exciting new approach to drug discovery and development, we are seeking a Study Project Manager II to support the successful execution of clinical trials.


  • Manage and lead the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements


  • Manage and lead cross-functional study teams, including external (CROs and other vendors) and internal (preclinical development, clinical, safety, regulatory affairs, CMC) partners in order to accurately coordinate clinical study activities. May supervise contract site monitors.


  • Coordinate clinical study timelines and liaises with project management to meet critical milestones; escalate issues that may jeopardize timelines and deliverables


  • Lead the development of study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables


  • Lead the preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team as applicable


  • Lead the feasibility assessment and selection of sites


  • Oversee the review of routine data and clinical aspects of timely data discrepancy resolution, data analysis, and the availability of top line results


  • Assure site compliance with the routine protocol and regulatory requirements and quality of data


  • Lead the preparation of written summaries of data reports, presentations, training material, and study documents (including pharmacy, laboratory, and operations manuals)


  • Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external study team members


  • Coordinate with finance to track the financial status against budget


  • Contribute to the development of clinical trial protocol synopses, protocols, amendments and informed consent documents


  • Conduct study monitoring visits and co-monitoring visits as needed and assures site compliance with the routine protocol and regulatory requirements and quality of data



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Requirements

  • Bachelor’s Degree in nursing, scientific, or equivalent required; Associate’s Degree, R.N., or equivalent with relevant experience is acceptable
  • Must have at least 8 years of Pharma-related/clinical research related experience in a CRO, pharmaceutical, or biotechnology company (On-site monitoring experience a plus)
  • Experience in oncology preferred
  • Strong knowledge of ICH/GCP guidelines
  • Strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring
  • Proven project management skills and study leadership ability
  • Able to prioritize multiple tasks, plan proactively, and accomplish goals
  • Must be self-motivated and adaptable to a dynamic environment
  • Strong experience in management of CROs and other vendors
  • Proven project management skills and study leadership ability
  • Excellent interpersonal, written and verbal communication skills and to collaborate effectively with cross-functional team members and external partners
  • Excellent computer skills in MS Word, PowerPoint, and Excel; experience with MS Project a plus
  • Able and willing to travel approximately 25-30%