CROProject Manager

Job Description

Job Description

Job Title : Project Manager-CNS

Job Status : Open to FT or Contractor candidates

Reports To : COO

Location : 100% Remote

Who we are : www.lotuscr.com

About this role :

The Project Manager is a proven leader in clinical program management in the clinical research industry, and manages, executes and reports on clinical study operations. This position provides leadership and support to members of the multidisciplinary project team, internally and externally. Responsibilities encompass the overall management of a project including budgeting, timeline adherence, internal and external communications, and project deliverables. Under limited to no supervision, act as the liaison between the sponsor, team members, and sites while managing projects to ensure quality service. This position will be part of the Clinical Operations Team, which is responsible for planning, executing, managing and closing projects associated with the company clinical study plans.

Responsibilities :

• Assumes primary accountability for assigned clinical research projects and ensures compliance with applicable regulations, guidelines, and corporate policies for study activities.
• Manages and executes the overall project scope, budget, and timelines. Identifies project success factors for analysis, reporting, and tracking.
• Manages resources and timelines associated with all study start-up and implementation activities, including CRO / investigator agreements, and contractual agreements.
• Leads the development of study specific protocols, consent forms, and other trial related materials as required.
• Ensures the appropriate development of study documents including, but not limited to, study plans, case report form instructions, site selection materials, investigator updates, and other project-specific documents required for the conduct of assigned studies.
• Participates in the review of clinical data for analysis.
• Ensures that all project tasks meet client expectations and are completed in accordance with the contract, trial protocol, and Standard Operating Procedures (SOPs).
• Serves as a liaison between clients and internal team to ensure project specific information and ongoing updates are proactively communicated.
• Plans for and manages all materials to support the appropriate execution of the clinical projects, including but not limited to distribution of documents, forms, supplies, equipment, and investigational device. Monitors adherence to project contract and budget.
• Coordinates with clinical, marketing, and operations management to identify goals and scope of clinical study projects. Ensures operational and regulatory integrity of assigned studies and participates in FDA or other regulatory authority inspections, as needed.
• Supports the management and oversight of clinical study related vendors. Reviews site monitoring reports ensuring finalization as required by SOP and / or client contractual requirements.
• Provide therapeutic training and guidance to clinical team.
• Attends off-site meetings and conferences, as needed.

Education and / or Experience :

Experience leading project operational teams through the start-up, study conduct, data management, and report writing of clinical studies. Strong written and verbal communication skills