Back to Job Search

Process Manager

  • Location: Lawrenceville
  • Job Type:Contract

Posted 25 days ago

  • Expiry Date: 09 July 2022
  • Referral: 209940@accuick.com

Job Description:

Position Responsibilities:

  • Providing guidance and support activities within Global Development Operations [GDO] to team members for all vendor oversight processes according to ICH E6 (R2) standards.

  • Support standardization of vendor oversight requirements and reporting readying organization for Inspection Preparedness

  • Training and development curriculum 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 in support of due diligence and assessment processes.

  • Ensure proactive engagement and positive support with management of stakeholders and cross-functional teams helping with operational alignment with vendor teams.

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

  • Exhibit ability to update SOPs/guidance documents, contributing to process improvement, methodologies and embedding best practices.

  • Support and evolve ongoing vendor oversight and documentation templates/processes across Clinical Trial Business Partnerships [CTBP].

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

  • Communicate clearly and concisely with all levels of organization.

  • Drive efficient and effective meetings with strong Project Management skill set.

  • Support other groups within GDO as necessary.

  • Support GVOO Team with other tasks, as needed.

Desired Experience:

  • Bachelors 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 CROs, 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, MS Project and Veeva Vault.

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.

Contact:

Full Name: Cathy Gandhi

Email ID: cathyg@askconsulting.com

Phone:(415) 534-272