Clinical Operations Manager

Clinical Operations Manager

Sandoz

Holzkirchen, Germany

Responsible for the planning, execution and delivery of assigned clinical operational activities in conduct of clinical trial(s). Ensuring all deliverables are met within defined timelines and maintaining high quality and compliance with Sandoz processes, ICH/GCP and applicable regulatory requirements. Proactively identifying and resolving operational issues; participating in process improvement initiatives as required. Work closely with Clinical Operations Associate Director (COAD) to ensure clinical study deliverables are met.

Your Key Responsibilities

Your responsibilities include, but not limited to:

• Execute assigned operational activities in conduct of clinical trial(s) in close collaboration with Clinical Operations Associate Director (COAD).
• Collaborate with External Service Providers (ESPs) to ensure timely delivery of outsourced tasks.
• Contribute to and/or provide oversight on the content of key trial documents e.g. clinical trial protocol, informed consent, trial-specific operating manuals, project plans, safety management plan etc.
• Contribute to trial feasibility, country allocation and site selection activities.
• Support in tracking study budget including processing invoices and accruals.
• Coordinate the development, maintenance, and execution of the cross-functional GCP Sponsor Oversight Plan.
• Plan and coordinate clinical trial quality risk management activities.
• Oversee outsourced monitoring activities including performing sponsor oversight visits at sites to proactively identify issues on a study, site and CRA level, as well as ensuring resolution of identified issues.
• Support IMP planning and management activities.
• Support clinical trial disclosure activities.
• Perform TMF QC and oversight in own area of responsibilities. Coordinate and track TMF QC activities to ensure inspection ready TMF.
• Oversee study close-out activities including review/contribution to clinical study report.
• Ensure timely identification, management and documentation of quality issues/deviations in conjunction with Clinical Quality Assurance (CQA).
• Support audit, Health Authority inspections and pre-inspection activities
• Support process improvement initiatives
• Performs other tasks, as assigned by the manager and tasks based on a specific appointment.
• Responsible for continuous personal and professional development (knowledge, skills and behaviors

Essential Requirements

• Minimum 5 years of experience in clinical development or associated fields. Experience in clinical operations is preferred.
• Solid knowledge of GCP and worldwide regulatory requirements related to assigned area.
• Very good interpersonal, problem-solving, negotiation and conflict resolution skills.
• Strong communication and organizational skills
• Experience in developing effective working relationships with internal and external stakeholders.
• Ability to analyse, interpret and present data
• Demonstrated ability to work independently.
• General knowledge of software systems and web-based applications. Good computer skills and willingness to learn new systems and applications
• Flexible to travel.
• Aim for eight bullet points

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