Associate Director / Director Global Clinical Process Management Lead
New
J
JobgetherPharmaceutical, Biotechnology
Based in United StatesFull-TimeDirector
SalaryAnnual salary range of $143,300–$193,300 USD.
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Job Details
- Languages
- English
- Experience
- Minimum of 8 years
- Required Skills
- Project ManagementMicrosoft OfficeChange ManagementProcess improvement
Requirements
- Bachelor’s degree in a relevant discipline, preferably in science, healthcare, or a related field.
- Master’s degree or other relevant postgraduate qualification is preferred.
- Minimum of 8 years of professional experience within the pharmaceutical and/or biotechnology industry.
- Extensive knowledge of clinical operations processes, ICH-GCP, and compliance management.
- Strong understanding of applicable clinical trial regulations and their practical application.
- Demonstrated experience in clinical trial process design, harmonization, optimization, and implementation.
- Experience working effectively in a global, matrixed organization.
- Experience developing, reviewing, and implementing SOPs, work instructions, templates, and other procedural documentation.
- Strong written and verbal communication skills with excellent presentation abilities.
- Fluent English, both written and spoken.
- Proficiency with Microsoft Office tools, including Excel, Outlook, Word, PowerPoint, and Project.
Responsibilities
- Lead and support global clinical process management activities across Global Clinical Operations.
- Serve as the primary Global Clinical Operations Excellence point of contact for assigned processes, including SOPs, work instructions, and related standards.
- Collaborate with Global Process Owners and subject matter experts to develop and maintain procedural documentation.
- Lead or contribute to the technical writing of SOPs, work instructions, templates, tools, and other controlled documents.
- Lead clinical process management initiatives in collaboration with relevant governance and process management groups.
- Support continuous improvement, change management, and implementation activities associated with process changes.
- Facilitate stakeholder evaluation, alignment, decision-making, and follow-through for process improvement initiatives.
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