Open Positions

The Sr. Clinical Trial Manager (Sr. CTM) leads the planning, implementation and execution of complex clinical study protocols, operational plans and study timelines, in alignment with study/program goals and strategic objectives. Ensures the study is conducted in accordance with FDA, EMA, GCP, and ICH guidelines and applicable local regulations to obtain the highest quality data. This role drives collaborative and effective management of cross-functional study activities, as well as communication with and management of external vendors and stakeholders (e.g., CROS, central IRBs/ECs, and other external partners). Proactively identifies, manages, and communicates risks to key stakeholders and is also in communication and closely integrated with clinical trial sites, promoting relationship development with team members, stakeholders, Investigators, and site staff.

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What will I do?

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• Ensure audit-ready condition of clinical trial documentation including the trial master file

• Ensure all assigned clinical trials are executed in compliance with ICH GCP guidelines/regulations and SOPs

• Plan, execute, and lead study-specific meetings

• Provides input to the clinical development plan and operational aspects of the clinical trial protocol

• Coordinate and assist in the planning of regulatory or ethics committee activities for clinical studies, as appropriate

• Manage assigned global clinical studies encompassing all aspects from start-up through close-out (reconciliation of Trial Master File)

• Proactively identify and resolve issues, escalate as appropriate

• Works cross functionally to develop internal work processes and procedures

• Oversees vendors to ensure timelines, goals, and deliverables are met with quality, within budget, and in accordance with SOPs, GCP, and all applicable laws and regulations

• Develops the clinical study enrollment strategy and track against enrollment timelines

• Provide monitoring oversight including assisting with the development of the clinical monitoring plan, reviewing monitoring visit reports, perform monitoring and oversight visits to sites and/or vendors to assess progress and compliance

• Provide study-specific mentor and training for clinical operation team members

• Participates in operational process improvement initiatives (including training, SOP reviews, and development of work instructions/tools/templates)

• Assists in the development and implementation of CRFs, performs user accepted testing on database, performs periodic review of the database and participates in the analysis of data

• Manage direct reports and monitor assigned activities

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Minimum Education and Qualifications

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• Bachelor’s degree in life sciences or a health-related field is preferred

• 5 years’ experience directly managing clinical trials within the Diagnostics, Biotech or Pharma industry, strongly preferred

• Solid understanding of the clinical trial database life cycle including, data collection, review, and analysis, CRF design, database development and testing

• Excels in a fast-paced, high-growth company environment with minimal direction and a high degree of independence and is able to adjust workload based on changing priorities

• Strong skills in collaboration, communication, organization, attention to detail and multi-tasking

• Demonstrated leadership, problem-solving, conflict resolution, and team building skills

• Ability to handle multiple projects and utilize judgement to prioritize tasks

• Ability to laugh at yourself

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Travel

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• Expected travel: 25-35%