Job Description :
Purpose and Scope of Position:
Plan, initiate and execute clinical studies (may have more than 1 and may be global) and implement appropriate standards and processes to ensure clinical study quality.
Responsible for effective management of budgets, timelines and resources for assigned clinical studies
Participate in task force or initiatives representing CSM
The scope of this position is Phase 1 through 4 clinical studies

Essential Job Responsibilities:
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.
Responsible for accurate and up-to-date study information within CTMS and other relevant tracking systems and providing regular updates; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues
Lead development of budgets and timelines for assigned studies.
Ensure accurate forecasting, tracking, timely review and escalation of variances within established processes.
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 documents
Participate in process improvement and quality-related initiatives associated with study execution and deliverables; participate in establishment of best-in-class processes and standards for study conduct

Use appropriate systems and standard processes to ensure quality and consistency.
Determine requirements and scope; lead selection activities and effectively manage vendors
Lead feasibility assessment and selection of countries and sites for study conduct
Oversee the timely data cleaning, clinical aspects of data analysis and the availability of top line results.
Ensure set-up and implementation of effective site monitor training; coordinate operational and therapeutic area training for internal and external study team members
Be accountable for effective training of study team, study sites and vendors for assigned clinical studies
Competent
Moderate guidance required
Responsible for the preparation and management of budgets, timelines and resources for assigned clinical studies.
Responsible for study budgets up to $100M.

CSM (D15):
Reports to Principal CSM, Associate Director or above.
This position has no direct reports but may provide direction to other CSM and Associate CSM

Qualification:
Minimum BA/BS degree or RN with 5+ years of direct clinical study management/project management experience including managing onoclogy trials of which 3 years must be direct study management in the pharmaceutical industry, including all stages of study conduct (start-up, maintenance, close-out
Global study experience is desired.
Must have a strong knowledge of ICH/GCP guidelines and regulatory requirements
Must have strong knowledge of clinical drug development processes including technical document review and preparation (protocols, clinical study reports, etc, clinical study design, study planning, management, and monitoring.
Requires proven project management skills in clinical research and study leadership ability
Must have excellent interpersonal, written, verbal , presentation, administrative and computer skills
Fluent in English (oral and written
Moderate (25%) travel required