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Process Manager

  • Location: Lawrenceville
  • Job Type:Contract

Posted about 1 month ago

  • Expiry Date: 16 January 2022

​​​​​​​​​​​​​​​​Job Description:

Candidates need TMF, GCP, GLP and/or Clinical GxP experience

Actual Job Title: Vendor Oversight Process Manager

Position Responsibilities:

  • Providing guidance and support activities within Global Development Operations [GDO] to team members for all vendor oversight processes

  • Support standardization of vendor oversight requirements and reporting

  • Training of all processes related to vendor oversight for involved staff to ensure adherence and efficient execution of activities.

  • Drive communication and training for GDO vendor oversight, assessment, and due diligence

  • Manage stakeholder engagement among cross-functional groups, as well as vendors to ensure team attendance / assistance / expertise providing help with a proactive attitude in supporting the team

  • Communicate clearly and concisely with all levels of organization

  • Contribute expertise and support for internal and external governance meetings and quality councils – exhibiting the ability to support issue management and escalation

  • Improve existing methods / establishing and embedding best practices for current SOPs

  • Exhibit ability to update SOPs/guidance documents

  • Exhibit ability to support ongoing vendor oversight and documentation across Clinical Trial Business Partnerships [CTBP]

  • Support Vendor audit/inspection Corrective and Preventative Action [CAPA] response & management.

  • Drive efficient and effective meetings

  • Support other groups within GDO as necessary

  • Support GVOO Team with other tasks, as needed

Desired Experience:

  • Bachelor’s degree required

  • At least 5years of relevant pharmaceutical industry experience, with demonstrated comprehensive understanding of clinical trial operations and management of vendors specializing in various service categories such as CRO’s, Labs, eCoA, IRT, etc.

  • Demonstrated good working knowledge of GxP and associated vendor oversight requirements and documentation

  • At least 5 years of demonstrated ability to define projects, to translate work into actionable plans,

  • Ability to effectively implement and manage projects, to meet key milestones bringing to successful conclusion

  • At least 5 years of a demonstrated track record of leading through influence, working across complex, global organizational matrices

  • Demonstrated quantifiable experience in change management and process improvement

  • Demonstrated ability to communicate, manage and work with cross-functional / teams in a complex, rapidly-changing, and complex, work- environment

  • Ability to define and balance priorities and multiple [sometimes competing] demands in a responsive and professional manner

  • Ability to recognize situational implications and ability to escalate and apprise leadership of status/issues

  • Proficient in the use of MS Office 365 suite including Excel OneNote and MS SharePoint; MS Visio and MS Project 

About ASK:ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.