Study Manager

Job Summary

The Study Manager (SM) works under the direction of Study Directors and Project Managers to support the quality completion of projects. The SM participates in all phases of the project process, provides guidance and training to team members, and drives projects to successful completion. The SM reports to the Project Management Office Manager or designee.

• 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.
• Provides input into SOP, WI, and CAPA documents.
• Keeps abreast of SOPs, Good Clinical Practice (GCP), ICH guidelines, state and national laws, and ethical standards.
• Provides clinical support for data management (Biometrics) by resolving data queries and clarifying 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 updates the Study Summary file with project‑specific information.
• Responsible for updating current processes and contributing to new processes to streamline activities, including providing training plans.
• Provides the Project Manager with timely and accurate status reports regarding project milestones and deliverables.
• Supports risk mitigation strategies as provided by PM and Associate Study Manager (ASM).
• Provides 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 is available for site visits, teleconferences, and tours, when required. Provides excellent customer service for sponsors, their representatives, and CRAs.
• Provides protocol and associated document review to support business development for requests for proposals.
• Ensures customer satisfaction and repeat business.
• Provides onsite leadership for the project team by building and motivating team members to meet project goals, adhering to responsibilities and milestones.
• Manages and oversees the designated ASM.

• Ability to read, write, and interpret the English language.
• Ability to lead by example and encourage team members to seek solutions.
• Planning, organizational, and time‑management skills.
• Oral, written, and presentation skills.
• Demonstrated analytical and 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, demonstrating teamwork, innovation, and excellence.
• Results oriented, capable of multi‑tasking, quick learning, responsive to urgent team needs, and track record of meeting deadlines.
• Good computer skills and inclination to adopt technology to maximize efficiency.

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

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

• Bachelor’s Degree in a scientific, nursing, healthcare management, business, or related field, preferred.
• Minimum of two years’ experience in Phase 1 clinical research and two years’ experience as a Clinical Research Coordinator or Study Manager, or four years of general clinical research experience in other phases.
• Demonstrated Good Clinical Practice and regulatory knowledge (ICH‑GCP).

This statement is intended to describe the general nature and level of work performed by people assigned to this job and is not an exhaustive list of all responsibilities, duties, and skills required.

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