CRO Project Manager – Contract

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 company policies.

• Oversee and implement the overall project scope, budget, and timelines.

• Identify key success factors for project analysis, reporting, and tracking.

• Manage resources and timelines for study initiation and execution, including agreements with CROs and investigators.

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

• Ensure the development of essential study documents such as study plans, case report form guidelines, site selection materials, investigator updates, and project-specific documentation.

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

• Ensure that project tasks align with client expectations and conform to contracts, trial protocols, and standard operating procedures (SOPs).

• Act as a liaison between clients, internal teams, and study sites, proactively sharing project updates and information.

• Manage materials necessary for clinical project execution, including documents, forms, supplies, equipment, and investigational devices.

• Monitor compliance with project contracts and budgetary constraints.

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

• Ensure the operational and regulatory integrity of the assigned studies.

• Participate in inspections by the FDA or other regulatory bodies as required.

• Support the management and supervision of clinical study vendors.

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

• Provide therapeutic training and guidance to the clinical team.

• Engage in departmental or corporate initiatives as needed.

• Carry out other related responsibilities as required.

⛳️ Requirements

• A Bachelor’s degree or equivalent education 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 with CROs is highly preferred.

• Proven experience in qualifying and managing external vendors.

• Demonstrated expertise in leading operational project teams through study initiation, conduct, data management, and clinical study report writing.

• Proficient in writing, reviewing, and editing protocols and clinical study reports.

• Familiarity with the FDA submission process is essential.

• Strong organizational and coordination skills are required.

• Effective teaching and facilitation abilities.

• Capability to assess training needs and objectives.

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

• Ability to manage multiple tasks concurrently.

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

• Ability to adhere to multiple deadlines.

• Proficient computer skills, including expertise in Microsoft Office.

🏝️ Benefits

• Opportunities to attend off-site meetings and conferences as necessary.

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