ICON Clinical Research

DOCS Operations Manager

22 Feb 2021
24 Mar 2021
Clinical Research
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Job Title: FSP Functional Manager

Location: Poland, Warsaw

At ICON, it's our people that set us apart.

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?

At ICON, we have an incredible opportunity for a FSP Functional Manager to join the team in our Poland, Warsaw location.

The Role:

The focus of this position is to functionally manage the operational aspects of trials through oversight and management of the assigned FSP staff. 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.
  • Line manages all assigned FSP staff as per requirements of role, including performance management.
  • Ensure FSP staff resources are identified and assigned as necessary to support Janssen clinical trials.
  • Country Lead / FSP FM and Janssen FM will define resource needs/requirements and FSP FM to monitor current situation per portfolio.
  • Partner with Country Lead / Janssen FM to assign FSP staff per needs of the Janssen portfolio (i.e., work assignments, workload requirements etc.).
  • Support FSP staff 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 (FSP FM will be trained on all relevant Janssen SOPs)
  • Support operational and process definition for the function.
  • Partner with Country Lead 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 FSP staff on their possible role in inspections and any necessary follow-up activities which result in a Corrective And Preventive Action (CAPA).
  • Ensure FSP staff have a clear understanding and knowledge of company 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 Country Lead, Regional Program Lead and/or central team leadership, suggest and implement solutions to problems with study timelines, schedules, resources, etc. Take corrective action where necessary.
  • Support the FSP staff 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 Country Lead / Regional Program Lead or as required by program requirements.
  • Ensure FSP staff 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 will need:
  • Bachelor's degree with prior line management and clinical experience preferred
  • Strong people management experience
  • Excellent English both written and spoken
  • Ability to manage the workload and capacity of FSP staff 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.)


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