DOCS Operations Manager

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 CTM's as per requirements of role, including performance management.
• Ensure CTM resources are identified and assigned as necessary to support Janssen clinical trials.
• The CTM Program Lead and Janssen FM will define resource needs/requirements and interact with CTM to review current situation per portfolio.
• Partner with CTM Program Lead to assign CTMs per needs of the Janssen portfolio (i.e., CTM work assignments, workload requirements and distribution and delegation of tasks to the supporting CTM.
• Support CTM 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 (CTM will be trained on all relevant Janssen SOPs)
• Support operational and process definition for the function. Partner with CTM and CTM 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 CTM on their possible role in inspections and any necessary follow-up activities which could result in a Corrective And Preventive Action (CAPA).
• Ensure CTM 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 CTM Program Lead, CTM.
• 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 CTM to ensure quality of work deliverables assigned meets requirements as defined in the Quality Oversight 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 CTM Program Lead or as required by program requirements.
• Ensure CTM 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 CTM'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