Job description

Position: Clinical Study Manager

Job Description Summary: Provides operational support to project directors. Responsible for the day-to-day management of project activities and deliverables. Serves as a liaison with the sponsor and vendors across all functional areas of the project. Assists in managing the project, ensuring that the quality of interactions and communications across the project is consistent with the sponsor and company expectations.

Responsibilities:

· Serves as a study contact for Sponsor and project vendors.

· Provides guidance to CRAs and CRCs in the planning, implementation, and closeout of clinical research projects. Serves as a point of contact for issue escalation.

· Develops key study documents, including but not limited to, Clinical Management Plans, Monitoring Plans, Informed Consent Forms, Case Report Forms, Study Reference Manuals/Regulatory Binders and source document templates.

· Reviews or oversees the review of monitoring trip reports.

· Manages vendors, including the implementation and coordination of vendor’s Scope of Work (SOW).

· Manages study budget and timelines. Identifies, resolves or escalates issues involving study timelines and deliverables.

· Develops, implements, and oversees enrollment plans and strategies.

· Oversees system development, ensuring a suitable fit for the protocol.

· Collects, tracks and reports established Key Performance Indicators such as query resolution, safety data collection or issues, drug reconciliation/shipment, site and patient enrollment, protocol deviations

· Identifies and establishes the suitability of study investigators and their investigative sites and liaises with them to ensure compliance with all necessary study requirements, approvals and agreements (e.g. financial and confidential).

· Ensures study conduct in accordance with appropriate SOPs, ICH/GCP Guidelines and local regulations.

Requirements:

· This position requires a B.S./B.A. or advanced degree in a health-related or scientific field and at least 5 years of experience in clinical research (or equivalent in education and experience)

· Relevant experience as a CRA preferred.

· Study planning and set-up, maintenance, and close-out experience.

· Must have a solid understanding of clinical research operations including GCP and regulatory requirements and operational procedures.

· Experience in ophthalmology preferred. Experience in a CRO setting is strongly preferred.

Skills & Attributes:

· Must be highly customer service oriented and have creative initiative with a positive attitude.

· Understands and shares the organizational values of developing and maintaining good relationships internally and externally. Quality of interactions reflects an emphasis on relationships.

· Able to work in a fast-paced environment and easily adapt to changing priorities.

· Must have excellent management and communication skills (written and verbal), strong problem-solving skills, and be detail-oriented.

· Advanced skills in computer operation, spreadsheet creation/maintenance, and word processing are essential.

· Proficiency in some software system(s) as appropriate for needs of department required.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Application Question(s):

• What industries have you worked in?
• How many years of experience do you have in a CRO setting?

Work Location: Remote

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