Clinical Research Project Manager

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

📋 Description

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

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

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

• Manage resources and timelines for the initiation and execution of studies.

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

• Guarantee the development of essential study documents, including study plans, case report form instructions, site selection materials, investigator updates, and project-specific documentation.

• Engage in clinical data review for comprehensive analysis.

• Ensure project tasks align with client expectations and comply with contracts, trial protocols, and SOPs.

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

• Organize and manage materials required for clinical project execution, such as documents, forms, supplies, equipment, and investigational devices.

• Monitor compliance with project contracts and budgetary constraints.

• Collaborate with clinical, business development, and operations management to define study project goals and scope.

• Uphold the operational and regulatory integrity of assigned studies.

• Participate 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 they are finalized according to SOPs and contractual obligations.

• Engage in departmental or corporate initiatives.

• Keep abreast of job knowledge through educational opportunities, professional publications, networks, and professional organizations.

• Attend off-site meetings and conferences as required.

⛳️ Requirements

• Bachelor’s degree or an equivalent qualification in life science/healthcare is essential.

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

• Experience in a CRO environment is highly preferred.

• Familiarity with managing external vendors is advantageous.

• Experience leading project operational teams through study initiation, conduct, data management, and report writing is preferred.

• Proficiency in writing, reviewing, and editing protocols and clinical study reports is preferred.

• A working knowledge of the FDA submission process is preferred.

• Ability to promote a teamwork philosophy and maintain a positive attitude.

• Strong organizational and coordination skills.

• Proficient teaching and facilitation abilities.

• Capability to assess team training needs and objectives.

• Experience supervising and coordinating the work of others.

• Ability to proficiently handle multiple tasks simultaneously.

• Skill in exercising judgment and determining appropriate actions for issues of varying complexity.

• Capacity to manage multiple deadlines effectively.

• Strong computer proficiency, including Microsoft Office.

• Ability to meet physical requirements, such as periodically lifting and/or carrying up to 10 pounds.

• Awareness of safety in both home and travel environments.

🏝️ Benefits

• 100% remote work.

• Opportunities for education and professional development.

• Participation in off-site meetings and conferences as necessary.