Lotus Clinical Research Clinical Project Manager-CNS

ZipRecruiter; New Providence (NJ); Remote; USD 100,000 - 125,000; Full time

Job summary

An established industry player is seeking a Clinical Project Manager to lead and manage clinical research projects in a fully remote capacity. This role involves overseeing project operations, ensuring compliance with regulations, and maintaining effective communication with multidisciplinary teams. The ideal candidate will have a strong background in clinical project management, particularly in CNS projects, and will be responsible for managing budgets, timelines, and project deliverables. Join a dynamic team where your leadership will drive the success of clinical studies and contribute to advancements in healthcare.

Qualifications

• 5+ years of experience in clinical project management required.
• CNS Project Management experience is essential.

Responsibilities

• Manage clinical research projects ensuring compliance with regulations.
• Lead project scope, budget, and timelines while communicating with stakeholders.

Skills

Clinical Project Management

Budget Management

Timeline Adherence

Regulatory Compliance

Communication Skills

Organizational Skills

Education

Bachelor's degree in life science/healthcare

Job description

Company: Lotus Clinical Research

Job Title: Clinical 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, managing, executing and reporting on clinical study operations. This position provides leadership and support to members of the multidisciplinary project team, both 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, responsible for planning, executing, managing, and closing projects associated with the company's 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, identifying 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 devices. 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.
• Provides therapeutic training and guidance to the clinical team.
• Attends off-site meetings and conferences, as needed.

Education and/or Experience:

• Bachelor's degree or equivalent education/degree in life science/healthcare is required.
• 5 years of working experience in clinical project management at a local medical organization, investigational site, pharmaceutical company, CRO, or clinical fellowship program.
• CNS Project Management experience is required.
• CRO experience is highly preferred.
• Experience qualifying & managing external vendors.
• Experience writing, reviewing, and editing protocols and clinical study reports as well as working knowledge of the FDA submission process.
• Excellent organizational skills.
• 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.