Sr CSM / CSM Position Description
- The purpose of this position is to: Plan, initiate and execute assigned clinical studies with operational excellence.
- Be accountable for effective management of budgets, timelines and resources for assigned clinical studies and implementation of appropriate standards and processes to ensure clinical study quality
- Be responsible for effective training and management of interactions with study team, study sites and vendors for assigned clinical studies The scope of this position is Phase 1 through 4 APGD-sponsored clinical studies.
- Manage and lead the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
- Manage and lead cross-functional study teams, including vendors.
- Provide accurate and up-to-date study information within CTMS and other relevant tracking systems and provide regular updates of study progression to Clinical Program Management and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues.
- Lead development of study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables.
- Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data.
- Lead preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team.
- Lead feasibility assessment and selection of countries and sites for study conduct.
- Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans.
- Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external study team members.
- Responsible for the preparation and management of budgets, timelines and resources for assigned clinical studies.
- Responsible for study budgets up to $100M.
- BA/BS degree with at least five years multi-country clinical trial experience or advanced degree (MS/PhD/PharmD) with at least 3 years clinical trial experience.
- Must have strong knowledge of ICH/GCP guidelines.
- Must have strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring.
- Requires proven project management skills and study leadership ability.
- Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
- Fluent in English.
- Moderate (25%) travel required.
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.