General Information

Location: Princeton, NJ, Remote

Organization: Medavante-Prophase, Inc

Job Type: Full Time - Regular

Description and Requirements


ABOUT WCG: WCG’s clinical solutions are built on a foundation of best-in-class clinical services companies. We deliver transformational solutions that stimulate growth, foster compliance, and maximize efficiency for those performing clinical trials. WCG is proud to serve individuals on the frontlines of science and medicine, and the organizations striving to develop new products and therapies to improve the quality of human health. It is our role to empower them to accelerate advancement, while ensuring the risks of progress never outweigh the value of human life.

WHY WE LOVE WCG: At WCG, our employees are our most valuable asset, and as with all our assets, we invest in them with an eye toward future success. We provide each eligible employee with a comprehensive set of benefits designed to protect their personal and financial health to help make the most of their future.

  • Comprehensive Benefits package - Health, Dental, Vision, Life Disability, 401k with match, and flexible spending accounts
  • Employee Assistance Programs and additional work/life resources
  • Referral Bonuses and Tuition Reimbursement
  • Flexible PTO
  • Volunteer Time Off to benefit the community
  • Opportunities for career development with on-the-job training, certification assistance, and continuing education reimbursement

The expected base salary range for this position is $62,460 to $97,000. This salary range may vary based on the candidate’s qualifications, experience, skills, education, and geographic location.

JOB SUMMARY: The 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 Project Manager ensures exceptional delivery of WCG services.

ESSENTIAL DUTIES/RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The accountabilities listed below are representative of the knowledge, skills, and/or ability required.

  • 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.
  • Attendance and punctuality are essential functions of the position.
  • Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.

EDUCATION REQUIREMENTS: Bachelor’s degree in related field  or the equivalent combination of education, skills and experience to perform the job.

CERTIFICATIONS/LICENSE/REGISTRATION REQUIREMENTS: PMP certification desired.

QUALIFICATIONS/EXPERIENCE:

  • Minimum 4 years’ experience in a clinical trials or research setting.
  • One to three (1-3) years’ experience managing linguistic validation, translation and localization projects or comparable experience.
  • One to three (1–3) years’ experience researching and managing the copyright and licensing/permission process of COAs or comparable experience.
  • Strong organizational and time management skills.
  • Proven ability to multitask.
  • Ability to support and build collaborative relationships both internally and externally.
  • Able to manage stressful situations with poise and professionalism.
  • 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.
  • Demonstrated ability to make timely decisions using sound judgment.
  • Ability to see the big picture as well as work hands-on. Ability to proactively recognize project challenges and implement effective action plans.
  • Experience in procurement and vendor management.
  • Well versed in linguistic validation process and operational aspects of clinical trials.
  • Demonstrated knowledge of copyright law and licensing/permission requirements for COAs.
  • Experience interfacing with and managing multiple vendors and sponsors.
  • Experience in project management required.

TRAVEL REQUIREMENTS:   

0% – 5%

5% - 10%

10% - 20%

20% - 50%

>50%

Physical and Sensory Requirements:  The physical and sensory requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be offered to individuals with disabilities to assist in performing the essential functions of the position. Work activities involve light to moderate physical effort (for example, sitting in one place for extended periods of time, standing, walking, bending, lifting lightweight objects, intermittent to sustained periods of keyboarding).  Majority of time is spent in a seated position with frequent opportunity to move about at will.  Activities require a variety of easy muscle movements.  Work activities involve a frequent need to concentrate on a variety of sensory inputs for moderate to lengthy durations at a time requiring diligence and attention to interpret effectively.  There will be a need to attend to single or simultaneous tasks where accuracy of details is important.  The need for detailed and precise work is high.  

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