Clinical Trial Manager

Key responsibilities

• With guidance from the Clinical Program Manager, ClinOps, responsibility for day-to-day activities within a region or regions, including site selection, start-up, maintenance, and close-out activities.
• Assist Clinical Program Manager, ClinOps with oversight of CRO and set-up of vendors as required, including liaising with Global CRO to ensure timely initiation of study.
• Day-to-day contact with counterparts at CRO and/or trial sites, including daily review and identification of potential issues or problems that must be communicated/escalated directly to Clinical Program Manager, ClinOps.
• Review site Informed Consent Forms and escalate to appropriate individuals, as needed. Assist with regulatory submission package review for submissions within region.
• Proactively identify potential operational challenges and, in collaboration with senior team members, provide solutions to ensure study execution remains on track.
• Perform accompanied visits (PSSVs, SIVs, RMVs) with CRO CRAs to ensure study procedure conduct is in accordance with SOPs and protocol procedures and review routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required.
• Review protocol deviations and monitor for trends.
• Carefully review trip reports generated by CRO CRAs for trends and quality issues.
• Coordinate review of data listings and preparation of interim/final clinical study reports, including resolving data discrepancies.
• Provide regular study updates to the appropriate internal stakeholders.
• Maintain internal Clinical Operations databases and document repositories.
• Perform administrative duties in a timely manner as assigned.
• Guide and support junior team members, ensuring alignment on deliverables, timelines, and quality standards.

Required experience & skills

• At least 4+ years of relevant experience with a BS or BA in a relevant scientific discipline or an RN (2- or 3-year certificate)
• Relevant clinical trial experience in the pharmaceutical or health care industry. Experience as the regional lead for Europe strongly preferred
• Excellent attention to detail, interpersonal and presentation skills are a critical asset
• Excellent organizational, problem-solving and time management skills
• Must be familiar with routine medical/scientific terminology
• Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable
• Must be familiar with Word, PowerPoint, and Excel (intermediate or higher excel proficiency a plus)
• Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision
• High energy level, personal productivity, creativity and commitment
• Highly adaptable team-player
• Strong written and verbal communication skills with a collaborative, team-oriented approach
• Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity
• Flexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitude