Associate Director, Clinical Operations Excellence – Standards Lead

🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $170.2k - $214.2k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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PTC Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 1998

PTC is a patient-centered biopharmaceutical company focused on discovering, developing & commercializing medicine for children and adults living with rare and serious disease.

📋 Description

• Collaborates with department leadership to create, establish, improve, and maintain operational processes • Leads and contributes to the development of departmental SOPs, guidance documents, and policies • Oversees the framework of processes within Clinical Operations to ensure continuity and transparency • Develops and assesses training for SOPs, working practices, and forms • Serves as primary contact for standards-related requests • Participates in reviews and working groups • Authors, updates, and manages Clinical Operations SOPs and templates • Ensures document version control, archival, and periodic review processes are followed • Partners with Clinical Operation leaders and study teams • Develops and executes rollout plans for new and revised standards • Monitors adoption and effectiveness of standards • Gathers user feedback and analyzes issues/trends

🎯 Requirements

• Bachelor’s degree in a relevant discipline • Minimum of 8 years of clinical operations and/or clinical trial operations experience • Demonstrated experience authoring and implementing SOPs, templates, work instructions, or other controlled documents in a regulated environment • Strong understanding of GCP/ICH principles and clinical trial lifecycle activities • Proficiency with Microsoft Office • Excellent verbal and written communication skills • Ability to work independently and collaboratively • Analytical thinker with excellent problem-solving skills • Excellent planning, organization and time management skills • Travel requirements 20-30%

🏖️ Benefits

• Short- and long-term incentives • Medical, dental, and vision plans • Retirement savings plans