Clinical Project Manager

Location
Bothell, WA, United States
Posted
Oct 09, 2018
Ref
FohDd8fwZ
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time

Summary:

A Clinical Project Manager (CPM) is responsible for the execution of a clinical trial or suite of clinical trials from protocol design to the final clinical study report. They manage the process and people involved though matrix reporting. The position is responsible for coordinating all efforts for the trial both within the Company and through a wide variety of vendors. A CPM coordinates other functional groups that comprise the clinical department indication team for the product; specifically, statistics, clinical monitoring, data management, medical writing, medical and safety to insure proper conduct and timely completion of all projects.

Responsibilities: 

The goal of a CPM is to drive development projects utilizing best practices in order to ensure budgets, timelines and performance requirements are met. Judgment is required to meet GCP, regulatory and SOPs and policies and to determine appropriate action.   The role requires active involvement, to meet schedules or resolve problems or conflicts, and entails frequent interaction with subordinates, outside customers, functional peer groups at various management levels and senior management.   Gaining project team cooperation, conducting presentations of technical information concerning specific projects and schedules and, solving technical problems, are keys to success.   Specific duties are outlined below but are not limited to:

  • Manages cross functional project teams derived from the groups within clinical development to deliver a high quality clinical trial(s)
  • Drives all aspects of the project management process from initiation, planning, execution, control and closure. Manages all aspects proactively
  • Assists in developing protocol concept sheet (study design, entry criteria and schedule of activities table). Reviews protocol and CRFs and tracks development to completion
  • Creates project budgets and manages cost to budgets. Develops enrollment projection, and drug supply needs as part of the budget
  • Responsible for creating and maintaining MS Project timelines for each project, and uses these timelines to track and manage a project’s progress
  • Responsible for creating Project Plans (e.g. Responsibility Table, and Communication Plans) and Study Data Sheet for each project
  • Reviews and approves the site contract template and budget template. Will review and approve any variations to the template
  • Reviews study-related support materials created by the Monitoring and Data Management Groups (e.g. study manual, monitoring plan, edit check manual, Listing Review process)
  • Reviews actual trial conduct and quality at all levels (i.e. monitoring, data management)
  • Responsible for periodic (weekly, or as needed) clinical trial team meetings
  • Reviews study metrics for performance and quality with the team and management
  • Ensures review of Clinical Trial Master File for completeness
  • Position has overall responsibility to deliver the projects on time and on budget. The CPM drives study conduct to timely completion in compliance with all regulations and SOPs
  • Requires the ability to negotiate and manage competing priorities across multiple functional areas
  • Works with functional areas on initiating, planning, executing, controlling, closing and resourcing clinical trial projects. The CPM acts as an operational nexus or focal point for interdepartmental and intradepartmental groups (e.g. stats, data management, safety, manufacturing, regulatory), coordinating these different groups in a matrix environment to drive and complete clinical programs
  • Insures all groups provide deliverables (i.e. query generation and resolution, data base lock, study report). Informs all groups of deliverables and timeline, project developments and insures completion according to timelines
  • Manage and coordinate all vendors involved in the clinical trials, e.g. central lab, CROs, including managing the RFP processes and overall budget for each
  • Prepares high-quality reports (financial, project, etc.) for management on program status and issues
  • Adhere to Clinical Operations or project specific quality documents (e.g. SOPs, work practices, training guides), as applicable

Qualifications: 

  • BA/BS or equivalent is preferred with a minimum of 6 years of pharmaceutical or biotech research experience
  • Highly effective organizational and communication skills
  • Knowledge of CFR and GCP/ICH requirements is required, as well as European Clinical Trial Directive knowledge is preferred
  • Demonstrated leadership skills and the ability to solve problems proactively
  • Willingness to travel approximately 10%
  • Proficiency with Excel, MS Project, Contract development and vendor oversight. CRO management experience a plus
  • Ability to plan, identify risks, anticipate issues and outcomes and respond strategically, tactically and operationally while balancing short-term and long-term objectives of the Company
  • Project Management Certification (PMP) is a plus

As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.

Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.