Organization: Medavante-Prophase, Inc.
Job Type: Full Time - Regular
General Project Management:
- Leads the customization of key control documents (e.g., project plans, communication plans, project governance structure, etc.).
- Develops and manages project timelines.
- Leads internal and external conference calls.
- Sets clear expectations for the team and establishes roles and responsibilities.
- Demonstrates an understanding of client needs and manages satisfaction relative to high-quality deliverable.
- Ensures profitability and utilization targets are met within the scope of work and budget.
- Communicates milestone billing completion to the Finance department.
- Coordinates and communicates with clients and all other stakeholders (investigative sites, third party vendors, etc.) to ensure the alignment of planned objectives to activities.
- Prepares project status documents and reports.
- Assists in closing down and archiving systems.
- Performs other daily tasks and special projects that support and contribute to the overall successful execution of the project life cycle.
- Routinely tracks budget items and facilitates reconciliation for all services against scopes of work.
- Coordinates, schedules, and maintains a series of global training programs for raters working on clinical research studies.
- Prepares training documents.
- Assists in the development of rater training presentations.
- Facilitates large scale training events (e.g., Investigator’s Meetings, Virtual Rater Training sessions).
- Works with third party vendors to set up the eLearning workspace for raters according to project specifications.
- Assists in the development of client training presentations, if applicable.
- Coordinates and sets up data for system launch as necessary.
- Coordinates distribution of materials to system end users.
- Manages escalations of issues as outlined in the Project Plan.
- Organizes, coordinates, and oversees translation, clinical review, and linguistic validation process.
- Coordinates activities related to licensing, budgeting, and distribution of scales.
- Provides oversight for distribution and shipment of scale binders through third party vendors.
- Creates, implements, and maintains the project management and operational support components involved in expert review and consensus rating support for study sites.
- Communicates with key technology vendors, including vendors of video and audio surveillance equipment and database solutions.
- Creates, tests, and implements processes and workflows to support seamless management of clinical quality assurance data in study.
- Leads and coordinates (conducts if appropriate) orientation for study site personnel and remote raters on equipment usage and workflow responsibilities for in-study activities.
- Sets out pre-production, production, and post-production objectives and timelines in accordance to project timeline and key milestones.
- Manages the timeline and cost of vendors conducting production and translation of all training materials.
- Bachelor’s degree required and/or 3-5 years related experience in a clinical project management environment (e.g.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.
- PMP certification preferred.
- 3+ years of experience in project management in the pharmaceutical services industry or in a related industry (e.g., clinical research).
- Excellent written and oral communication skills, organization, interpersonal skills, and ability to work with people from a variety of backgrounds.
- Fluency in English required and multilingual fluency is a plus.
MedAvante-ProPhase, a subsidiary of WIRB-Copernicus Group (WCG) was founded in 2002 with the goal of helping to bring better drug therapies to market through smarter, faster clinical trials. With this goal in mind, MedAvante set out to solve one of Pharma’s most intractable problems: the bias and variability that cause failed or inconclusive trials for Central Nervous System (CNS) therapies. A few years later, MedAvante experts pioneered Central Ratings and introduced the concept of Central Review utilizing their groundbreaking Virgil eSource solution.
WCG is proud to be an equal opportunity employer – Qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, sexual orientation, gender identity, age, marital status, disability, veteran status or any other status protected by law.