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Project Coordinator


RESPONSIBILITIES:

  • Utilizes knowledge of CAPA process and system requirements to support cross-functional CAPA teams in understanding the CAPA process and achieving timebound milestones
  • Tracks adherence to CAPA completion process steps and assists CAPA teams in maintaining on-time completion of CAPAs by advising of process requirements and monitoring process adherence and completion
  • Liaises with many different groups/organizations in the GCP area to coordinate completion of CAPAs
  • Proactively identifies and facilitates resolution of obstacles to timely CAPA completion
  • Gathers, analyzes and presents data to key stakeholders within Global Drug Development (GDD)
  • Provides input into continuous improvement opportunities
  • Gathers and monitors tends, and supports trend analysis and metric tracking
  • Fosters Teamwork and Inclusion: Practices inclusion and seeks different perspectives. Committed to organizational goals; contributes to inclusion and collaboration among teams.
  • Commitment to Quality: Understands and embraces the need to deliver quality products and/or services throughout the enterprise.
  • Recognizes Global Implications and diversity: Seeks to understand issues, trends and perspectives of various cultures and countries; recognizes that what works in one's own country will not necessarily work in another; addresses cultural and geographic differences in strategies and approaches.
  • Demonstrates Adaptability: Handles day-to-day work challenges, clearly articulates questions and provides recommendations; is willing and able to adjust to multiple demands, shifting priorities, ambiguity and rapid change; shows resilience in the face of constraints, frustrations or adversity; demonstrates flexibility. Understands and stays focused on high priority activities
  • Analysis of Issues: Gathers and tracks relevant information systematically; understands and differentiates between risks and issues; seeks input from others; escalates appropriate issues appropriately
  • Innovation: contributes to new ideas; open and interested in process improvement opportunities and initiatives

    QUALIFICATIONS
  • Basic understanding of ICH-GCP environment and experience in Clinical Operations
  • Attention to detail, problem solving ability and quality mindset
  • Good interpersonal, oral and written communication skills
  • Ability to work in diverse and highly matrixed environment
  • Ability to respond flexibly to changing business demands and opportunities, proactively looking for ways to contribute
  • Ability to ask questions to better understand the rationale for and benefits of change
  • Ability to deal constructively with mistakes and setbacks
  • Ability to maintain a high level of performance in the face of ambiguity or change
  • Ability and willingness to accept challenging assignments and new responsibilities
  • Demonstrated basic project management skills (organization, collaboration, multi-tasking and communication), attention to detail, and the ability to perform well in a team-based environment are required
  • Focuses on Results: understands priorities; conveys a sense of urgency and drives to complete tasks; persists despite any obstacles
  • Proficiency with the following: Veeva platform (for eTMF, QMS, and CTMS), Excel, SpotFire, and Tableau
  • Experience with SOPs, GCP and demonstrated proficiency working within a regulatory environment required
  • Prior experience in CAPA management and tracking is preferred Education/Experience/ Licenses/Certifications: (list required education and experience, along with any additional education/experience/qualifications that are preferred)
  • BA/BS in life sciences or equivalent with 2+ years of experience in clinical operations, quality assurance or equivalent


Job Requirements:
RESPONSIBILITIES: Utilizes knowledge of CAPA process and system requirements to support cross-functional CAPA teams in understanding the CAPA process and achieving timebound milestones Tracks adherence to CAPA completion process steps and assists CAPA teams in maintaining on-time completion of CAPAs by advising of process requirements and monitoring process adherence and completion Liaises with many different groups/organizations in the GCP area to coordinate completion of CAPAs Proactively identifies and facilitates resolution of obstacles to timely CAPA completion Gathers, analyzes and presents data to key stakeholders within Global Drug Development (GDD) Provides input into continuous improvement opportunities Gathers and monitors tends, and supports trend analysis and metric tracking Fosters Teamwork and Inclusion: Practices inclusion and seeks different perspectives. Committed to organizational goals; contributes to inclusion and collaboration among teams. Commitment to Quality: Understands and embraces the need to deliver quality products and/or services throughout the enterprise. Recognizes Global Implications and diversity: Seeks to understand issues, trends and perspectives of various cultures and countries; recognizes that what works in one's own country will not necessarily work in another; addresses cultural and geographic differences in strategies and approaches. Demonstrates Adaptability: Handles day-to-day work challenges, clearly articulates questions and provides recommendations; is willing and able to adjust to multiple demands, shifting priorities, ambiguity and rapid change; shows resilience in the face of constraints, frustrations or adversity; demonstrates flexibility. Understands and stays focused on high priority activities Analysis of Issues: Gathers and tracks relevant information systematically; understands and differentiates between risks and issues; seeks input from others; escalates appropriate issues appropriately Innovation: contributes to new ideas; open and interested in process improvement opportunities and initiatives QUALIFICATIONS Basic understanding of ICH-GCP environment and experience in Clinical Operations Attention to detail, problem solving ability and quality mindset Good interpersonal, oral and written communication skills Ability to work in diverse and highly matrixed environment Ability to respond flexibly to changing business demands and opportunities, proactively looking for ways to contribute Ability to ask questions to better understand the rationale for and benefits of change Ability to deal constructively with mistakes and setbacks Ability to maintain a high level of performance in the face of ambiguity or change Ability and willingness to accept challenging assignments and new responsibilities Demonstrated basic project management skills (organization, collaboration, multi-tasking and communication), attention to detail, and the ability to perform well in a team-based environment are required Focuses on Results: understands priorities; conveys a sense of urgency and drives to complete tasks; persists despite any obstacles Proficiency with the following: Veeva platform (for eTMF, QMS, and CTMS), Excel, SpotFire, and Tableau Experience with SOPs, GCP and demonstrated proficiency working within a regulatory environment required Prior experience in CAPA management and tracking is preferred Education/Experience/ Licenses/Certifications: (list required education and experience, along with any additional education/experience/qualifications that are preferred) BA/BS in life sciences or equivalent with 2+ years of experience in clinical operations, quality assurance or equivalent
Company
ACS Solutions
Posted
01/07/2022
Salary Range
$46,000.00 - 74,000.00
per Year
Salary range estimated by
Location
Lawrence Township, NJ 08648, US