Job Description

Project Manager with Trackwise Exp
Job Number: 21-05672
 
Use your skills where innovative technology solutions begin. Eclaro is looking for a Project Manager with Trackwise Exp for our client in Canonsburg, PA.
 
Eclaro’s client is a leading technology solutions provider, collaborating with customers to manage their needs and achieve success in their business goals. If you’re up to the challenge, then take a chance at this rewarding opportunity!

Responsibilities:

 
  • Manage all aspects of project including scope, schedule, cost, risk, procurement, quality, resources, communications, and stakeholders
  • Manages the day to day operational and tactical aspects of multiple or large-scale projects
  • Oversees management and coordination of vendor and internal resources responsible for project engagements
  • Ability to Coordinate multiple vendors across various time zones and manage their tasks according to a given project schedule
  • Ensures quality assurance procedures are followed and in accordance with Customer's methodology and standards
  • Manages scope and mitigates risk across projects
  • Accurately forecasts capital, expense, and utilization across projects. Updates status reports on consistent basis.
  • Serves as key participant in project team meetings.
  • Tracks and monitors project progress and team resources.
  • Confronts issues openly and quickly. Resolves and/or escalates issues in a timely manner
  • Effectively communicate relevant project/practice information to IT and Business leadership and peers
  • Minimizes exposure and risk across multiple projects
  • Developed supporting validation documents based on CSV standards, client SOP and Health Authority regulations
 

Qualifications:
 
  • Knowledge of Trackwise
  • Knowledge of other QMS like Veeva, ePROGESA, Amplexor, Documentum is a plus.
  • Should have managed large QMS implementation projects including configuration migrations, data migration, multi-site and multi geography rollouts, data archival etc.
  • 3-5 years' experience in a Pharmaceutical/Life Sciences setting is preferred
  • Experience with industry-standard and best practices regarding quality, quality assurance and quality control principles and techniques (e.g., 21 CFR Part 11, GAMP 5)
  • Versed in health authority regulations such as FDA 21 CFR, MHRA Annex 11
  • SME (Subject Matter Expert) in GxP (GDP, GCP), Data Integrity
  • SME (Subject Matter Expert) in Computer System Validation (CSV)
  • Knowledgeable in GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems
  • Broad technical knowledge of Argus Safety System application
  • Good understanding on qualification and validation of CSV processes
  • Must have 5-7 as project manager leading and directing mid-level complexity projects to successful completion
  • Bachelor's degree. Applicable disciplines are Project Management, Engineering, Pharmaceutical or related technical discipline. PMP preferred.
  • Proficient in Microsoft Project, Powerpoint, Excel, and Teams

If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro

If interested, you may contact:
Steve Adams       
Steve.Adams@eclaro.com       
866-577-3379
Steve Adams | LinkedIn


Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. 

 

Application Instructions

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