Senior Clinical Trial Manager/Associate Director Clinical Operations

Position Overview

The Senior Clinical Trial Manager/ Associate Director Clinical Operations will act as an operational lead reporting directly to the VP Clinical Operations (US). Responsible for the planning, execution and conduct of commercially sponsored clinical trials as well as oversight of any investigator-initiated trials being conducted. Trials are to be executed on time, within budget, compliant with all relevant regulatory and ethical requirements, and be of the highest quality to support submission to relevant authorities for ultimate drug approval.

The initial focus will be the day to day management a Phase 1b/2a study of MTX240 in GIST.

Key Responsibilities:

• Delivery on all clinical operational aspects of assigned clinical trial/s ensuring compliance with all applicable laws and regulations, company Standard Operating Procedures (SOPs), study contracts, budgets and timelines from start up through to clinical study report
• Primary interaction with internal and external cross functional teams and key stakeholders, ensuring clinical trial and department objectives are met
• Supporting the assessment and selection of Contract Research Organisations (CROs)/other vendors, seeking input from other internal functional updates and ensuring qualification of vendors in accordance with company SOPs
• Oversight of CROs/vendors by serving as primary contact, problem resolution and defining Key Performance Metrics
• Liaise with KOLs and academic institutions
• Tracking of project deliverables using appropriate tools incorporating risk management
• Prepare reports for management on program status and issues
• Support writing and coordinating review of key documents, including but not limited to protocols, subject information sheets/informed consents, case report forms, study plans and clinical study reports
• Coordination of audits as required, responding to CAPAs and ensuring trials are always Inspection Ready
• Involvement in general Clinical Operations department initiatives/activities including reviewing SOPs and input into process improvements 
• Contribute to other Clinical Operations and R&D Department/company activities and initiatives as required

Skills and Attributes

• Minimum of a Bachelor’s degree in life science, medical, or related field
• 5-7 years of relevant clinical operations experience within pharmaceutical/biotech/CRO industry
• Experience overseeing CROs and/or other vendors
• Excellent organisational, analytical, planning and project management skills
• Demonstrated ability to prioritise multiple competing tasks
• Effective communication skills and cross functional collaboration skills
• Excellent knowledge of Good Clinical Practice, ICH guidelines and appropriate regulations
• Ability to work independently and within small teams
• Self-starter and team player who thrives in a fast-paced environment

Role Requirements

• Permanent, full-time position (possible 3-4 days week)
• US home-based in Texas, with a requirement to travel occasionally to clinical sites domestically/Internationally as necessary for the clinical program/s
• Will lead a Phase 1b/2a study in an orphan indication, so experience in early phase studies essential
• Experience in GI / rare disease indications preferred but not essential

No agencies or consultancies at this time.