DOCS Operations Manager

This is an exciting opportunity to join ICON

As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them?

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

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 Janssen 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 Janssen 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 requirements.
• 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 Janssen'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 necessary.
• Support the G-CTA (Study-facing) to ensure quality of work deliverables assigned meets requirements as defined in the Quality Plan agreed with Janssen.
• 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.

What you need

• 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.
• 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