Vendor Oversight Process Manager For Clinical Trials

VENDOR OVERSIGHT PROCESS MANAGER FOR CLINICAL TRIALS LAWRENCEVILLE, NJ Hybrid 50% Onsite. Project Description:

• 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.
• Support and evolve ongoing vendor oversight and documentation templates/processes across Clinical Trial Business Partnerships [CTBP] and in support of the Global Clinical Trials Strategy & Organization [GCTS&O] and other Functional Service Categories as identified.
• Support Vendor audit/inspection Corrective and Preventative Action [CAPA] response & management.
• Manage, support and track adherence to vendor oversight processes.
• 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.
• 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.

Required Skills:

• 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 (CRA, site and/or central monitoring a plus).
• Strong Google Cloud Platform and ICH knowledge, including local/regional guidelines which are applicable to clinical research and the regulatory landscape.
• 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 Project and Veeva Vault.

This 6+month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: ALPHA'S REQUIREMENT #23-00308 MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE