CRO – Project Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Take primary responsibility for designated clinical research projects while ensuring adherence to relevant regulations, guidelines, and corporate policies.

• Oversee and implement project scope, budget, and timelines effectively.

• Determine success factors for projects to facilitate analysis, reporting, and tracking.

• Manage resources and schedules for study initiation and execution activities, including agreements and contracts with CROs and investigators.

• Lead the creation of study-specific protocols, consent documents, and trial-related materials.

• Ensure the formulation of study plans, case report form instructions, site selection documents, investigator updates, and other essential project materials.

• Engage in the review of clinical data for analytical purposes.

• Confirm that project tasks align with client expectations and comply with contracts, protocols, and standard operating procedures (SOPs).

• Act as a liaison among clients, internal teams, sponsors, and sites.

• Organize and manage materials essential for clinical project execution, including documents, forms, supplies, equipment, and investigational devices.

• Oversee adherence to contracts and budgets.

• Collaborate with clinical, marketing, and operations management to establish study objectives and scope.

• Ensure operational and regulatory integrity, participating in FDA or other regulatory authority inspections as necessary.

• Assist in the management and oversight of clinical study vendors.

• Review site monitoring reports to ensure compliance with SOPs and contractual obligations.

• Provide therapeutic training and support to the clinical team.

• Engage in departmental or corporate initiatives while keeping up-to-date with job knowledge.

• Carry out other related duties as required.

⛳️ Requirements

• A Bachelor’s degree or equivalent education/degree in life sciences or healthcare is mandatory.

• A minimum of 5 years of experience in clinical project management within a local medical organization, investigational site, pharmaceutical company, CRO, or clinical fellowship program.

• Experience in a CRO setting is highly advantageous.

• Proven experience in qualifying and managing external vendors.

• Demonstrated ability to lead project operational teams through study initiation, conduct, data management, and clinical study report writing.

• Experience in drafting, reviewing, and editing protocols and clinical study reports.

• Familiarity with the FDA submission process is required.

• Strong organizational and coordination skills are essential.

• Teaching and facilitation skills, including the ability to assess training needs and objectives.

• Significant experience in overseeing and coordinating the work of others.

• Capability to manage multiple tasks simultaneously and meet various deadlines.

• Ability to exercise sound judgment and determine appropriate actions for problems of varying complexity.

• Proficient computer skills, particularly in Microsoft Office.

🏝️ Benefits

• Opportunity to attend off-site meetings and conferences as required.

• Access to educational opportunities, professional publications, personal networks, and professional organizations.

• Involvement in departmental or corporate initiatives.