General Information

Location: Hamilton, NJ, New York, NY

Organization: Medavante-Prophase, Inc

Job Type: Full Time - Regular

Description and Requirements

The Senior Project Manager, Scale Management is responsible for licensing, acquiring and obtaining translations of Clinical Outcome Assessments (COAs) in sponsor clinical trials. With a focus on all aspects related to the acquisition of COAs and their linguistic validation/localization, The Senior Project Manager will serve as the bridge between our clients, internal teams and partners in order to manage the delivery of Scales Management Services to our clients

VACCINATION REQUIREMENT:

To be considered for U.S.-based positions unless currently employed by WCG, where permitted by applicable law (including any applicable reasonable accommodation, medical or religious exemption), candidates must have received or be willing to receive the COVID-19 vaccine by start date.

EDUCATION REQUIREMENTS:

Bachelor’s degree in related field and/or 5 years related experience in a clinical project management environment (CRO, pharmaceutical company, or other centralized service provider used in clinical studies) or the equivalent combination of education, skills and experience to perform the job.

QUALIFICATIONS/EXPERIENCE:

Preferred

  • Experience in linguistic validation process and operational aspects of clinical trials.
  • Knowledge of copyright law and licensing/permission requirements for COAs.
  • Experience managing and interfacing with multiple vendors and sponsors.
  • Minimum of 1 year of supervisory experience recommended.

Required

  • At least five (5) years of demonstrated project management experience with strong understanding of the project life-cycle, and ability to manage and execute projects on time and within budget.
  • Strong organizational and time management skills.
  • Ability to support and build collaborative relationships both internally and externally.
  • Clear and concise in verbal and written communication, fosters smooth flow of timely and relevant information
  • Demonstrated ability to work independently; Strong initiative and positive attitude;
  • Clear and concise in verbal and written communication, fosters smooth flow of timely and relevant information;
  • Ability to see the big picture as well as work hands-on. Ability to proactively recognize project challenges and implement effective action plans.
  • Excellent organizational and planning skills with the ability to utilize technology and tools to enhance the effectiveness of deliverables and service.
  • Ability to function effectively in a fast-paced environment and manage multiple projects simultaneously.
  • Proficient knowledge of MS Office, specifically Word, Excel, PowerPoint and MS Project and the ability to produce detailed reports and presentations using these tools.

ESSENTIAL DUTIES/RESPONSIBILITIES: 

    • Coordinate efforts to secure necessary permissions and license agreements.
    • Manage life cycle of translation/linguistic validation projects.
    • Work with various department functions to develop a robust library of translated electronic forms and learning materials.
    • Serve as resource/subject matter expert for internal teams with regard to linguistic validation.
  • Participate in sponsor meetings, as required.
  • Identify, qualify, and secure vendors for third party services
  • Liaise with vendors to ensure quality implementation and strict adherence to timeline on all projects.
  • Negotiate timelines and pricing with vendors.
  • Identify and track KPIs.
  • Review and approve invoices for pass through costs.
  • Support process improvement and the development of SOPs that drive efficiencies to reduce project timelines and maintain or enhance quality.
  • Implement and continuously improve quality management practices.
  • Mentor and train supporting resources.
  • Provide updates on project activity to the Executive team and other departments as required.
  • Participate in sponsor audits as needed.
  • Lead special projects, initiatives as identified by management.
  • Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.
  • Attendance and punctuality are essential functions of the position.

SUPERVISORY RESPONSIBILITIES: 

  •  
  • Supervise, train and mentor junior direct and adjunct staff when assigned direct staff.

TRAVEL REQUIREMENTS:

·       5-10%