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Clinical Process Leader
1 miesiąc temu
Natek is seeking a Clinical Process Leader to support a global pharmaceutical company in the leadership, lifecycle management, and continuous improvement of assigned system processes.
The Clinical Process Leader will work closely with the System Owner, vendor(s), Business Process Management Office, R&D IT, internal and external customers, and stakeholders to ensure customer needs are met and to enable optimal end-to-end delivery of clinical studies.
Key Responsibilities:
- Ensure customer requirements are understood, critically evaluated, prioritized, and addressed within the allocated system process area.
- Lifecycle management of system processes, including design, development, implementation, maintenance, and continuous improvement.
- Engage and influence internal and external key stakeholders to drive system processes strategy, development, and continuous improvement.
- Develop and deliver high-quality guidelines, user manuals, training materials, relevant templates, and toolkit documents.
- Provide advice, training, and end-user support for system processes and other system supporting documents.
- Define, track, and monitor key performance indicators of the allocated system process and use data to inform selection of system process improvements and input to cross-functional improvements.
- Deliver Corrective and Preventive Actions (CAPA) to time and quality and act on data or trends identified through the Quality & Risk Management process.
Requirements:
- At least 5+ years of experience in a similar role.
- Extensive experience in Drug Development within a pharmaceutical or clinical background.
- Strong business process, technology, and Clinical Study information knowledge.
- Strong operational knowledge of system processes in the clinical trial setting.
- Demonstrated project management skills and proven skills to deliver to time, cost, and quality.
- Ability to work collaboratively, motivate, and empower others to accomplish individual, team, and organizational objectives.
- Vendor Management experience in working successfully and collaboratively with external partners delivering mutual benefit.
- Demonstrated excellent written and verbal communication and influencing skills, negotiation, collaboration, problem-solving, presentation, knowledge transfer (mentoring), conflict management, and interpersonal skills.
Nice to Have:
- Experience of utilizing standard process improvement methodologies (e.g., Lean Six Sigma) to identify root causes of process issues and identify areas of process improvement.
- Experience in Technical Writing.
- Experience in the development and management of Business Processes to deliver business performance.
- Comprehensive knowledge of ICH/GCP.
- Experience in Validation of computerized systems in a regulated environment, preferably the Pharmaceutical industry, including familiarity with documentation such as Validation Plans, Reports, Test scripts, etc., and knowledge of regulatory (GxP, SOX, etc.) requirements for computerized systems and infrastructure.
- Experience in Quality Systems and Quality Management, including process definition and process improvement, ideally within an Information Systems environment.