DOCS Operations 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.

Summary:
The focus of this position is to functionally manage the operational aspects of the Global Clinical Development Operations (GCDO) managed trials through oversight and management of the G-CTAs (Study-facing). 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 G-CTA (Study-facing) as per requirements of role, including performance management.
• Ensure G-CTA (Study-facing) resources are identified and assigned as necessary to support Janssen clinical trials.
• The G-CTA Program Lead and Janssen FM will define resource needs/requirements and interact with G-CTA FM to review current situation per portfolio.
• Partner with G-CTA Program Lead to assign G-CTAs (Study-facing) per needs of the Sponsor portfolio (i.e., G-CTA (Study-facing) work assignments, workload requirements and distribution of tasks to the supporting G-CTAs (Central)).
• Support G-CTA (Study-facing) 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 (G-CTA FM will be trained on all relevant Sponsor SOPs)
• Support operational and process definition for the function.
• Partner with G-CTA FMs and G-CTA Team Leads (TL) to identify, interview, on-board, and train staff per company-specific standards/expectations and trial specific
• Support inspection readiness activities. Align with Janssen-led activities to coach G-CTA (Study-facing) on their possible role in inspections and any necessary follow-up activities which could result in a Corrective And Preventive Action (CAPA).
• Ensure G-CTA (Study-facing) 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's training and learning system.
• Track all training metrics and follow-up with employees who are out of compliance.
• As necessary, and in partnership with G-CTA Program Lead, G-CTA FMs and G-CTA Team Leads and/or central team leadership, suggest and implement solutions to problems with study timelines, schedules, resources, etc. Take corrective action where needed
• Support the G-CTA (Study-facing) to ensure quality of work deliverables assigned meets requirements as defined in the Quality 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 G-CTA Program Lead or as required by program requirements.
• Ensure G-CTA (Study-facing) 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.
• Ability to manage the workload and capacity of G-CTA (Study-facing) locally.
• Ability to motivate others and enhance performance through excellent, clear and concise communication of goals and expectations.
• Experience in identifying and hiring staff to fulfil role.
• Ability to train and mentor others.
• Ability to work cross-functionally to meet business objectives.
• 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.
• Excellence in utilization of Microsoft Office applications (EXCEL, WORD, PowerPoint, Outlook) and Internet based systems (WebEx, eTMF, SharePoint, etc.).

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.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON 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, color, 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 through the form below.