STUDY MANAGER

SPAULDING CLINICAL RESEARCH LLC•West Bend, WI

2d•Onsite

About The Position

The Study Manager (SM) works under the direction and guidance of, and with, Study Directors and Project Managers to perform duties as directed to support the quality completion of projects. The SM participates during all phases of the project process under the guidance of senior Managers to support other team members, provide guidance and training as needed, and to drive projects to successful completion. The SM reports to the Project Management Office Manager or designee.

Requirements

Planning, organization, and time management skills
Ability to work creatively and analytically in a problem-solving environment
Proactive contract scope management
Demonstrated knowledge of EMEA and FDA regulatory requirements
Ability to provide input into SOP, WI, and CAPA documents
Presentation skills
Keeps abreast of SOPs, Good Clinical Practice (GCP) and ICH guidelines, state and national laws and ethical standards.
Ability to read, write, and interpret the English language.
Ability to lead by example and to encourage team members to seek solutions
Planning, organizational, and time management skills
Oral, written and presentation skills
Demonstrates analytical, problem solving skills
Excellent written and verbal communication skills
Demonstrated attention to detail
Self-motivated, decisive, with the ability to adapt to change and competing demands
Ability to work creatively and analytically in a problem-solving environment with multiple ongoing trials and demonstrating teamwork, innovation and excellence.
Must be results oriented, multi-tasking, quick learner, respond to the urgent needs of the team and show a track record of meeting deadlines.
Good computer skills; inclination to adopt technology to maximize efficiency
Demonstrated "Good Clinical Practices" and regulatory knowledge (ICH-GCP)

Nice To Haves

Bachelor’s Degree in Scientific related Fields, Nursing, Healthcare Management, Business or related field, preferred
Minimum of Two years’ experience in Phase 1 clinical research and two years’ experience as Clinical Research Coordinator or Study Manager or 4 years of general clinical research experience in other phases or research

Responsibilities

Throughout the study, ensures that all study activities are executed per the study protocol, regulatory guidelines, and operational/project plan.
Provides clinical support for data management (Biometrics) by resolving any data queries and clarifying data queries as requested and by timeline.
Monitors clinical conduct to ensure adherence to protocol.
Conducts a close-out inventory of clinical supplies, materials, pharmacy supplies, and coordinates the return of unused materials per Sponsor instruction.
Participates in quality assurance of clinical research studies and initiates the need for same as it impacts on clinical practice.
Provides study performance metrics as requested and update Study Summary file with project specific information.
Responsible for updating current processes and contributing to new processes in order to streamline activities. This includes providing training plans to ensure gained knowledge and compliance.
Provide to Project Manager timely and accurate status reports regarding project milestones and deliverables
Support Risk Mitigation strategies as provided by PM and Associate Study Manager (ASM)
Provide prompt and thorough review (with appropriate feedback) on all study issues and escalations from PM, ASMs, and Floor Staff
Is present for customers (sponsors), as requested and be available for site visits, teleconferences, and able to provide tours, if required.
Willing and able to provide excellent customer service for all sponsors, their representatives, CRAs, etc.
Provide protocol and associated document review to support business development for requests for proposals are provided
Ensure customer satisfaction and repeat business.
Provide onsite leadership for project team by building and motivating team members to meet project goals, adhering to their responsibilities and project milestones.
Manage and oversee designated ASM