STUDY MANAGER

THIS IS AN ON SITE POSITION

Job Summary:

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.

Essential Duties and Responsibilities:              

• Throughout the study, ensures that all study activities are executed per the study protocol, regulatory guidelines, and operational/project plan.
  • 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.
  • 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

The Statements made in the job description are intended to describe the general nature and level of work being performed by people assigned to this job.  These statements are not intended to be an exhaustive list of all responsibilities, duties and skills required of people assigned to this job.

Skills/Qualifications              

• 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

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers, to handle or feel.
• Ability to lift and/or move up to 25 pounds.
• Specific vision abilities required by this job include clarity of vision both near and far. 
• Ability to identify and distinguish colors.

Hazards:

• Potential for exposure to toxic or caustic chemicals
• Potential for exposure to blood borne pathogens

Education and Experience:

• 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
• Demonstrated "Good Clinical Practices" and regulatory knowledge (ICH-GCP)

Spaulding Clinical Research management has the discretion to hire personnel with a combination of experience and education which may vary from the above listed skills and qualifications.

Salary : $70,000 - $85,000