Sr Mgr, Inspection Readiness (DG)

Date Posted: 11/2/2023

Senior Manager, Inspection Readiness (DG)
(REMOTE), East Coast Only, NJ
Salary - $130-155K base plus 15% bonus, 15% equity

The Senior Manager Inspection Readiness leads cross-functional activities to support trial audit, inspection, and CAPA/deviation follow-up to ensure delivery of trials according to quality standards defined by SOPs, ICH GCP, and regulations. We a looking for a Senior Manager Inspection Readiness driven by ensuring a one-team culture and who excels in contributing to great teamwork and a working environment. Join our innovative, hardworking, and ambitious team collaborating in a high-performing and high pace environment to improve the lives of cancer patients.

The Role
As a Senior Manager Inspection Readiness, you will: Lead cross-functional activities to support trial audit, inspection, and CAPA/deviation follow-up to ensure delivery of trials according to quality standards defined by SOPs, ICH GCP, and regulations. In the Clinical Oversight team in Development Operations, we are currently more than 20 highly motivated and experienced people located in Denmark, the US, the Netherlands, and New Zealand.
Working in Development Operations is exciting, intense, challenging, and fun at the same time. The dedication, collaborative and knock-your-socks-off spirit of our employees are what really shapes our team. From day one, the onboarding program makes sure that you accomplish trainings, get settled with our IT systems and that you team up with your mentor, colleagues, and relevant stakeholders.

Responsibilities
The Senior Manager Inspection Readiness will lead inspection activities on trials and programs before, during, and after inspections and make sure that all trials are inspection-ready at any time. The principal responsibilities are: Development of processes to support trial team in overseeing activities and ensuring inspection readiness. Support overall development of the operational strategy related to dashboard development and AI to support inspection readiness. Support trending across trials, programs, and vendors in relation to findings. Drive/coordinate all activities with Quality Assurance (QA) Department prior to and during inspection. Defining inspection readiness activities and tools to be used by Clinical Trial Teams (CTTs) to ensure oversight and ongoing inspection readiness. Act as counterpart for CROs during inspections. Attend inspections either in back or front office. Final review of all CAPAs/deviations and change request related to the clinical trials and ensure timely response including content review. Develop strategy related to training on inspection readiness of CTTs. Drive gap analysis internally and of CRO SOPs. Support storyboard development in preparation of inspections. Act as deputy related to serious breach discussions. Attend clinical vendor audits and support vendor inspections. Trial counterpart for all vendor inspections and site inspections towards QA. Responsible for trending across trials, programs, and vendors in relation to findings and make proposals for process changes. Represent trials/Development Operations in Portfolio Oversight Committees and Executive Steering Committees with vendors to drive inspection readiness discussions.

Requirements:
Bachelor’s or master’s degree with relevant specialization; Master's degree preferred. Minimum requirement: 8+ years of relevant experience in clinical or development operations from a pharmaceutical company and/or CRO. Experience within the field of oncology and/or first-in-human trials is preferred. Significant experience leading and managing clinical oversight. Experience in leading multiple complex trials in terms of oversight and compliance. Some experience managing/guiding internal (cross-functional) and external (CRO, vendors) teams. Excellent communication skills in English both written and spoken. Writing scientific documents, project plans and other requirements from a compliance and regulatory standpoint. Knowledge of Good Practices (GxP), regulatory compliance and documentation requirements relevant for scope of work. Experience with on-site and off-site monitoring of clinical trials with in-depth knowledge of monitoring requirements including data review. Experience overseeing vendors by monitoring vendor performance (quality, metrics, data trends) including individual site performance.

Where you will work:
This role can be located in Princeton, NJ; Copenhagen, Denmark; Utrecht, the Netherlands; and is hybrid or can be remote.

Moreover, you meet the following personal requirements:
Dedicated team player who enjoys leading teams and inspiring trust among colleagues. Quality mindset and ability to prioritize your work in a fast-paced and changing environment. Result- and goal-oriented and committed to contributing to the overall success of the company. For US based candidates, the proposed salary band for this position is as follows:

Please contact Darren Gutowski at dgutowski@clarkdavis.com