- Manage day-to-day monitoring activities on assigned study to ensure deliverables are met by tracking and maintaining project metrics and status of deliverables. Proactively communicate and escalate issues, risks and staffing needs to Program Lead, RSMs and Clinical Trial Team.
- Act as a resource for RSMs to answer study questions and provide guidance as Allergan standard study process experts.
- Review completed Site Feasibility Questionnaires, Site Qualification Visit reports and maintains all tracking reports (SIV, IMV, RMV, COV) for assigned trial.
- Develop monitoring documents and toolkits for trial to ensure consistency such as Protocol Specific Monitoring Plan and amendments, report annotation, visit checklists, tool kits, etc. Provide PSMP training and assist with conducting GSMO orientation sessions as necessary.
- Conduct with RSM teleconferences to deliver training and information as required. Attend team meetings and disseminate information as necessary.
- Collaborate with CTT and GSMO PL in review of study specific eCRFs, completion guidelines, protocol deviation specifications, user acceptance testing, etc.
- Serve as Risk Based Monitoring (RBM) ambassador ensuring implementation and adherence to RBM requirements on trial.
- Maintain monitoring portion of study portal.
- Maintain knowledge of ICH/GCP, regulatory requirements, Allergan SOPs, therapeutic area (protocol, amendments).
- Site presence (may be responsible for monitoring 1 sites on assigned trial or co-monitoring/oversight visits, etc.)
- Principal LSM additional tasks: mentoring new LSMs, assisting with LSM orientation training sessions, contribute to process development, improvement and documents to drive consistency. Principal LSMs will typically be assigned to more complex therapeutic areas.
Qualifications
- Allied Health Professions degree (PA, RN, RPh), relevant clinical experience, or four-year life science degree.
- Minimum 5 years monitoring experience in a pharmaceutical or medical device company or clinical research organization.
- More than 5 year of industry experience.
- Prefer candidates that have functioned as a lead monitor/ have equivalent experience.
Skills
Advanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft OneNote
Must possess excellent skill/ability in the following:
- Written and oral communication
- Planning, Organizing, Metrics Tracking
- Controlling, Directing, and Promoting Innovation
- Decision Making, Judgment, and Problem Solving
- People Relationships, Influencing Others, Motivating Employees, Team Building, Developing People
- Initiative and Accountability
- Assigning work, reviewing work, and Planning other’s work
- Maintaining activities and Coordinating activities
- Training RSMs on trial specifics
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