Associate Clinical Study Manager
1 Astellas Way Northbrook, IL 60062
JOB TITLE: Associate Clinical Study Manager
Reports to Senior, Clinical Study Management or above
Must have solid clinical studies experience
Local candidates only, candidates who are willing to relocate at their own expense may be submitted.
Interview travel expenses are not reimbursable by the client
This position has no direct reports but may provide oversight and direction to study team members
for study deliverables and may provide supervision to Clinical Trial Associates.
Regulatory documentation and CRO experience is acceptable.
PURPOSE & SCOPE:
Participate in or lead the planning, initiation and execution of assigned clinical
studies with operational excellence.
Be responsible 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. This position may work under the direction of Senior Clinical Study Manager or may lead the management of assigned studies, as appropriate.
ESSENTIAL JOB RESPONSIBILITIES:
Manage 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 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.
Participate in or lead the 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.
Participate in or lead preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team.
Participate in or 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.
Provide oversight and direction to study team members for study deliverables.
QUANTITATIVE DIMENSIONS: Responsible for the preparation and management of budgets, timelines and resources for assigned clinical studies. Responsible for study budgets up to $50M.
ORGANIZATIONAL CONTEXT: Reports to the Senior Manager, Clinical Study Management or above. This position has no direct reports but may provide oversight and direction to study team members for study
- BA/BS degree with at least three years multi-country clinical trial experience or advanced degree
- (MS/PhD/PharmD) with at least 2 years clinical trial experience
- Must have strong knowledge of ICH/GCP guidelines and regulatory requirements.
- Must have knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring.
- Requires 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.