Director, Global Clinical Process Management

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee and facilitate global clinical process management activities within Global Clinical Operations.

• Foster efficient, uniform, sustainable, and compliant processes and standards throughout Global Clinical Operations.

• Act as the primary point of contact for one or more GCO processes, which include SOPs, Work Instructions, and associated standards.

• Create content and collaborate with Global Process Owners and Subject Matter Experts on GCO procedural documentation.

• Assume the role of Global Process Owner when applicable.

• Drive process management initiatives, revisions of controlled documents, continuous improvement efforts, change management, and implementation activities.

• Recognize and promote innovative ideas that enhance GCO processes.

• Manage document review and approval workflows.

• Provide guidance on processes managed by other functions that influence GCO processes and standards.

• Build partnerships with GCO and cross-functional teams, including GCP Compliance and Learning and Development.

• Contribute to the strategic direction of training materials pertaining to GCO processes.

• Ensure adherence to ICH-GCP and relevant regulatory requirements.

⛳️ Requirements

• A bachelor's degree is required; a master's degree or other relevant postgraduate qualifications are preferred.

• Proficient in English (both oral and written).

• A minimum of 8 years of experience in the pharmaceutical and/or biotechnology industry.

• In-depth understanding of clinical operations processes, ICH-GCP, and compliance management.

• Familiarity with clinical trial regulations.

• Experience in the design, harmonization/optimization, and implementation of clinical trial processes.

• Background in working within a matrix environment and with global teams.

• Proficient in Microsoft Excel, Outlook, Word, PowerPoint, and Project.

• Outstanding interpersonal, problem-solving, negotiation, and conflict resolution abilities.

• Excellent organizational skills and a strong inclination towards quality management and process enhancement.

• Effective oral and written communication capabilities.

• Strong presentation skills.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial roles.

• Eligibility for an incentive compensation plan for commercial roles.

• Discretionary equity awards available.

• Employee Stock Purchase Plan offered.

• Comprehensive medical insurance.

• Dental insurance coverage.

• Vision insurance provided.

• 401(k) retirement plan.

• Flexible Spending Account/Health Savings Account options.

• Life insurance benefits.

• Paid Time Off.

• Wellness benefits included.