Job Information
ICON Strategic Solutions Clinical Operations Lead, Quality Assurance in Helena, Montana
As a Quality Clinical Operations Lead , you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
This position is accountable, under the leadership of the Senior Director of Dev Ops Quality (DOQ) or designee, to develop and lead inspection readiness activities for key programs within Clinical Operations. This position will liase with the COL or Senior COL counterpart on the study team to:
Assess current status of Clinical Trial’s Inspection Readiness (IR) preparations.
Execute Inspection readiness Prep activities as directed by the SWAT Clinical Trial Manager (swCTM)
Provide ongoing support during the pre, during and post inspection readiness phases.
S u mm a r y o f the E s s en tial Functions o f the Jo b
Consult on and execute strategy on the Inspection Readiness Support Plan with the Study CTM/Sr. CTM, Asset
Lead,QARepandDevOpsQualitySr.Directorordesignee
Identify areas driven by the Study COL/Sr. COL that may need additional resource support
Coordination with Study COL’s to ensure Study Teams and Vendors are adhering to Study Plans
Perform a Study Plan Gap Analysis
Lead Liaison with Vendors to ensure compliance to IR activities
Lead Liaison support to Study COL for IP supply reconciliation
Assist QA in prepping key sites for inspections and attaining requested documents from inspectors as directed.
Supporting QA in IR team meetings
Maintains training on up to date regulations and IR best practices
Support of DOQ and supporting departments teams during lulls in inspection
Ensures adherence to GCP and all applicable local and internal regulations
Maintains IR Sharepoint Site with relevant materials as directed by the SWAT CTM
May be assigned Clinical Trial Manager responsibilities, with oversight, as a development opportunity
Minimum Requirements:
BS/BA degree or a relevant degree with strong emphasis on science;
Minimum of five years of experience in the biopharmaceutical industry or other relevant clinical research experience in the conduct and management of multinational clinical trials
Able to manage complex and/or large trials
Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience
Extensive experience in Inspection Preparation/Inspection participation
Ability to effectively manage multiple priorities simultaneously.
Demonstrated leadership and problem solving skills
Experience in all phases of a clinical trial lifecycle from initiation to clinical study report
Used to work in a multidisciplinary setting, strong cooperative team player, ability to be flexible and adapt to a changing environment
Good planning, prioritization, problem solving and organizational skills; strong customer-orientation, used to work independently
Strong communication skills, used to communicate with a broad range of stakeholders and to build strong positive relationships
Why ICON?
Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.