Description
Responsibilities:- Directs a multi-functional study team in the day-to-day execution of clinical trials
- Partners with Clinical Operations management and Project Management to define study milestones and deliverables and executes to ensure timelines, budget and quality are met.
- Actively participates in CRO, site and vendor selection in order to ensure that trial responsibilities are appropriately delegated and that partners are aligned with corporate objectives; provides ongoing surveillance of progress and ensures that contingency plans are triggered as and where appropriate
- Provides mentorship, supervision and training to other Clinical Operations Staff assigned to the study, which may include direct and indirect reports and contract monitors.
- In collaboration with the Medical Monitor and other Clinical Operations personnel, may lead the planning and execution of successful Investigator Meetings.
- Works to resolve day-to-day issues in the timely onboarding and initiation of clinical sites, and challenges in the efficient enrollment of study subjects; monitors and reports on the progress of site initiation and subject recruitment.
- Supervises site monitoring, reviews monitoring reports and metrics, and participates in site auditing to ensure that these tasks are performed reliably and in compliance with applicable regulations
- Ensures that the study team is up-to-date on current program status and priorities and ensures the goals/objectives are aligned with the corporate goals
- Develops and refines monitoring plans as well as lab and pharmacy manuals, training manuals, and other procedural manuals as needed to ensure that the trial is conducted consistently across countries and sites.
- Oversees biometrics vendors, partners with external service providers to develop data management plans, edit check specifications, analysis specifications, etc.
- Develops expertise and understanding specific to the assigned therapeutic area(s) and builds upon information from previous trials to better the conduct of current and future studies; ensures that program-wide structure and long-term implications are taken into consideration when operational decisions are made (for example CRF design, SAE databases and coding dictionaries, etc.) - pro-actively works with supervisor to anticipate long-term implications of such decisions.
- Provides regular status reports and metric updates of studies to senior management and to project management; works with other Clinical Operations personnel to identify risks within studies and proactively plans mitigation strategies
- Participates in internal/external audits of vendors/sites; works pro-actively to identify compliance risks and partners with team members to trigger preventive or corrective actions where appropriate
- Works closely with the Medical Monitor regarding safety reporting and interacts with CRO personnel to ensure timely and accurate delivery of data for safety monitoring committees.
- Leads departmental or interdepartmental infrastructure and process improvement initiatives where assigned; partners effectively with supervisor to build and continually improve department infrastructure.
- Assists with the writing of clinical protocols, Investigator Brochures and annual IND reports where required; reviews and contributes content to these documents to ensure their accurate description of trial status and study subject events.
- May travel domestically and internationally (up to 30%,) independently and sometimes on short notice
Requirements:
- Bachelor's degree in a scientific field and 7+ years of clinical trial experience, including at least 4 years of independent trial management experience in a Sponsor company
- Must have independent site monitoring and management experience, and demonstrated track record of increasing levels of responsibility in complex clinical trial management
- Direct supervisory experience with multiple direct reports strongly preferred
- Broad knowledge of clinical drug development processes, industry standards, GCPs, clinical trials monitoring, regulatory compliance and an understanding of clinical data management and statistical reporting
- Thorough knowledge of ICH/GCP guidelines as well as 21 CFR and other applicable regulations.
- Proven organizational skills with ability to manage multiple urgent priorities in parallel
- Well established leadership and influence skills - able to adapt to different environments and circumstances and to influence and effectively motivate internal and external team members.
- Excellent analytical, negotiation and problem-solving skills
- Flexible, adaptable, and able to react to changing circumstances and priorities
- Outstanding interpersonal and communication skills - able to articulate complex issues effectively in person, and in writing; diplomatic when interacting with multiple internal and external 'customers'.
- Displays a high level of commitment and professionalism in all environments; leads by example