The Clinical Trial Manager (CTM) provides oversight of clinical trials according to all applicable regulations and guidance, ICH/GCP and SOPs. The CTM leads the cross-functional clinical trial team and partners with internal and external team members/key stakeholders ensuring alignment of activities with study projects and timelines to include, but not limited to: CRO and vendor selection, contracting and management; inspecting and monitoring CROs; clinical trial protocols and patient recruitment; system design and activation; risk mitigation plans and assessments; reporting and metrics; and safety events and reporting.
What you'll dive into
• Leads the clinical operations team (CRAs and CTAs) and cross-functional clinical trial team in the planning, execution and reporting of clinical trials, ensuring alignment of activities with study timelines, budgets, SOPs, GCP and applicable regulatory guidelines
• Proactively identifies and resolves operational issues/processes to ensure achievement of study milestones, data quality and data integrity; escalates study-related issues appropriately in a timely manner
• Obtain and relay key study issues, status updates and other study information to the clinical trial team and management
• Manages recruitment efforts and activities to meet study enrollment goals and timelines, and provides status to upper management
• Interacts with other functional areas and key stakeholders, including Clinical Development, Data Management, Finance, Regulatory, Quality Assurance, Safety, Clinical Supply (Investigational Product) and clinical vendors (e.g., central laboratory, CROs), as needed, to support clinical trial activities
• Provides input on the development of eCRF design
• Participates in IRT, EDC and ePRO user acceptance testing
• Participates in data cleaning, listing, and report output reviews
• Develops, reviews, and approves study-related manuals, plans, specifications, charters, newsletters, and materials
• Participates in protocol deviation listing reviews and meetings
• Responsible for oversight of study budget, investigator and vendor contracts, budgets and payments
• Participates in protocol, table, figure, data listings and clinical study report reviews
• Develops presentations for clinical sites, team and investigator meetings
• Provides oversight for the setup, maintenance, and close-out of the Trial Master File and ensures it is complete and audit ready
• May be responsible for a defined region, vendor or process across a program
• Performs other work-related duties as assigned or required
What we expect
• Bachelor's degree or licensed health-care professional (e.g. RN)
• 4+ years of relevant and progressive clinical trial management experience
• Strong understanding of clinical trials processes, protocols and medical terminology
• Strong experience utilizing, EDC, TMS and related software
• Prior experience in management and monitoring of CRO and investigative sites
• Strong experience with patient recruitment, non-compliance, safety, document management, investigational product, IP accountability, and budget management
• Broad knowledge of ICH, GCP, IRB/IEC and local regulatory authority drug research & development regulations
• Motivated to work in a fast-paced, high accountability environment
• Experience in our focused therapeutic areas, preferred
• Travel up to 20%
Additional Skills & Qualifications:
Study start-up preferred
Global experience preferred
May be used for studies all across the ulcerative colitis program
2-4 years of CTM experience
Review plans, specs
Vendor oversight. Will work closely with the CRO.
Open to CRO only candidates depending on the candidate. Must have vendor management experience
Prior monitoring experience is preferred
GI experience preferred. Pediatrics study would be preferred as well.
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The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.