ICON Clinical Research

DOCS Operations Manager

07 Apr 2021
10 Apr 2021
Clinical Research
Full Time
Contract Type
Experience Level
Experienced (non-manager)
At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.

Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That's our vision. We're driven by it. And we need talented people who share it.
If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.

The focus of this position is to functionally manage the operational aspects of the Global Clinical Development Operations, managed trials through oversight and management of the CRA's. Responsibility for capacity management and resourcing of tasks associated with trial start up, execution or close out in all phases of clinical trial development. The range of tasks may vary to some degree depending on the therapeutic area and trial specific requirements.

The Role
  • Line manages all assigned CRA's as per requirements of role, including performance management.
  • Ensure CRA resources are identified and assigned as necessary to support the sponsors clinical trials.
  • The CRA Program Lead and Sponsor will define resource needs/requirements and interact with CRA to review current situation per portfolio.
  • Partner with CRA Program Lead to assign CRAs per needs of the Sponsor portfolio (i.e., CRA work assignments, workload requirements and distribution and delegation of tasks to the supporting CRA).
  • Support CRA delivery of trial and/or activity-specific milestones on time and within budget with quality and in compliance with all relevant SOPs, policies and applicable regulatory requirements (CRA will be trained on all relevant Sponsor SOPs)
  • Support operational and process definition for the function. Partner with CRA and CRA Team Leads (TL) to identify, interview, on-board, and train staff per company-specific standards/expectations and trial specific requirements.
  • Support inspection readiness activities. Align with Sponsor-led activities to coach CRA on their possible role in inspections and any necessary follow-up activities which could result in a Corrective And Preventive Action (CAPA).
  • Ensure CRA have a clear understanding and knowledge of GCO SOPs, Work Instructions (WI) and Instructions For Use (IFU) supported by documentation of training compliance in Sponsor training and learning system.
  • Track all training metrics and follow-up with employees who are out of compliance. As necessary, and in partnership with CRA Program Lead.
  • Team Leads and/or central team leadership, suggest and implement solutions to problems with study timelines, schedules, resources, etc. Take corrective action where necessary.
  • Support the CRA's to ensure quality of work deliverables assigned meets requirements as defined in the Quality Oversight Plan agreed with Sponsor.
  • Manage DOCS Operational deliverables to requirements as designated by agreed program key performance indicators and the operational metrics.
  • Track all operational metrics and quality plan deliverables and report at least monthly to CRA Program Lead or as required by program requirements.
  • Ensure CRA align with trial/program-specific Goals and Objectives (G&O) as they apply to their scope of responsibilities and accountability.
  • Manage all organizational aspects of staff management as required by DOCS systems and processes.
  • Ensure client and DOCS operational systems are current and accurate all times to facilitate accurate reporting, analysis and business operations.

What you need
  • Ability to manage the workload and capacity of CRA's locally and in coordination globally.
  • Ability to motivate others and enhance performance through excellent, clear and concise communication of goals and expectations.
  • Strong, confident communication and presentation skills (client facing and internal)
  • Experience in identifying and hiring staff to fulfil role.
  • Ability to train and mentor others.
  • Ability to work cross-functionally to meet business objectives.
  • Flexibility in changing priorities
  • Excellent organizational, written and verbal communication skills (English) and the ability to work independently within a global, virtual team environment.
  • Excellent independent time management skills.
  • Proven ability to plan and track deliverables and timelines.
  • Excellence in providing quality work and being detail oriented.
  • Bachelor's degree with prior line management and clinical experience preferred. However,
  • other relevant experiences and skills may be considered by the hiring manager when considering the candidate's eligibility

Benefits of Working in ICON:
Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.

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