Clinical Trial Manager/Senior Clinical Trial Manager

Clinical Trial Manager/Senior Clinical Trial Manager

Requirements

• Bachelor’s degree required; preference to candidates with a scientific background
• At least 5 years clinical research experience in a biotech/pharmaceutical company or clinical research organization (CRO) for Clinical Trial Manager level
• Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations / ICH / GCP guidelines, is required
• Strong attention to detail, time management and excellent organizational skills
• Strong interpersonal skills and communication skills (both written and oral)
• Ability to problem solve, delegate appropriate tasks, work within a team environment and mentor junior team members such as CTAs/CRAs
• Excellent sense of urgency to deliver at/surpass study conduct targets
• Strong leadership skills, self-motivated, adaptable to a dynamic environment
• Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities

Responsibilities

• Responsible for leading all operational aspects and progress of clinical trial which can include but is not limited to: study planning activities; study execution including ongoing tracking of all applicable performance metrics; and quality indicators
• Serve as an escalation point and resource for study team and investigative sites
• Facilitate and review the site feasibility process and oversee the site selection processes
• Oversee subject recruitment / retention strategy and related initiatives
• Provide operational input for study documents such as synopsis, and protocol, and develops/approves ICFs, CRFs, CRF Completion Guidelines, study plans, including Clinical Monitoring Plan, Protocol Deviation Plan, Risk Management Plan, etc.
• Develop protocol training materials for CRAs and site-facing materials for SEVs, SIVs and ad-hoc training
• Responsible for oversight of study teams in review of clinical data in conjunction with Data Management; provides guidance on issues / queries as needed and implements risk management concepts as appropriate
• In conjunction with the Lead CRA, this position will be responsible for motivating and leading the assigned clinical monitoring team to deliver on study timelines and milestone deliverables
• Oversee monitoring visit schedule to ensure compliance with frequency set forth in CMP
• Review site monitoring visit reports for clarity and completeness and escalates issues identified
• Participate in clinical vendor selection process as a part of outsourcing activities
• Assist in the review and approval of vendor and site budgets along with the study director
• Provide oversight for all clinical vendor activities (e.g., specifications development, UATs, issues escalations, KPIs)
• Work closely with QA to drive CAPA review, implementation, and completion
• Oversee the eTMF set-up, ongoing quality review, and final reconciliation of study documents
• Ensure that all aspects of GCP compliance and audit/inspection readiness are maintained throughout trial conduct
• Create, manage, measure, and report timelines for milestone deliverables
• Proactively manage and identify potential study issues and risks as well as recommend and implement solutions with key internal / external stakeholders
• Lead internal team meetings, and other trial-specific meetings
• Participate in the development, review, and implementation of departmental SOPs, initiatives, and processes
• May conduct Site Evaluation visits (SEVs) and Site Initiation Visits (SIVs)
• Review and approve vendor invoices for all clinical trial vendors including investigative sites

Preferred Qualifications

• Preference to energetic candidates with a desire to think “outside the box”
• Willingness to travel as needed, up to 20%