Ref #: 29643

Employment type: Permanent - Full-Time

Location: Argentina

Posted: 02-Jun-2021

Description

Job Functions/Responsibilities
• Line manages all assigned CTA and CRAs as per requirements of role, including performance management.
• Ensure resources are identified and assigned as necessary to support client´s clinical trials.
• Partner with program leads and support per needs of the client portfolio work assignments, workload requirements and distribution of tasks to the supporting CTAs and CRAs.
• Support the 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 (OM will be trained on all relevant to client´s SOPs)
• Support operational and process definition for the function.
• Support inspection readiness activities. Align with client-led activities to coach employees on their possible role in inspections and any necessary follow-up activities which could result in a Corrective And Preventive Action (CAPA).
• Ensure employees have a clear understanding and knowledge of GCO SOPs, Work Instructions (WI) and Instructions For Use (IFU) supported by documentation of training compliance in client’s training and learning system.
• Track all training metrics and follow-up with employees who are out of compliance.
• As necessary, suggest and implement solutions to problems with study timelines, schedules, resources, etc. Take corrective action where necessary.
• Support the employees to ensure quality of work deliverables assigned meets requirements as defined in the Quality Plan agreed with the client.
• 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 clients Program Lead or as required by program requirements.
• Manage all organizational aspects of staff management as required by DOCS systems and processes.

Experience:
• MUST have SSU experience
• Ability to manage the workload and capacity of CTAs and CRAs 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.).