Clinical Project Manager

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

📋 Description

• Oversee the initiation of study activities by examining protocol requirements, creating project plans, establishing timelines and milestones, and managing project documentation.

• Develop and uphold project communication strategies, reporting timelines, and stakeholder updates for both sponsors and internal leadership.

• Determine success metrics for projects, supervise project advancement, and proactively address risks, resources, and operational challenges.

• Administer project finances, which includes forecasting, billing processes, scope assessments, amendments, revenue tracking, and pass-through expenses.

• Ensure adherence to study protocols, Standard Operating Procedures (SOPs), relevant regulations, and quality standards.

• Organize data collection efforts across various sites and collaborate with internal and external partners to ensure successful project outcomes.

• Lead project teams by establishing expectations, providing training, mentoring team members, and fostering a collaborative work atmosphere.

• Convey protocol clarifications and updates to project teams, ensuring a uniform understanding of study requirements.

• Assist in business development initiatives through client presentations, capability discussions, investigator meetings, and participation in industry events.

• Manage project closure activities, which include submission assistance, final deliverables, and completion of study tasks.

• Execute supervisory duties as necessary, including performance management, employee development, hiring assistance, and workforce planning.

• Propel continuous improvement efforts that enhance departmental workflows, project results, and client satisfaction.

⛳️ Requirements

• A Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Healthcare, or a related discipline, or an equivalent combination of education and experience.

• Proven experience managing clinical research projects involving investigational products within a Contract Research Organization (CRO) or pharmaceutical setting.

• Experience in clinical trials with the ability to manage multiple projects, timelines, and stakeholders effectively.

• Familiarity with Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and U.S. Food and Drug Administration (FDA) regulations.

• Experience in project planning, budgeting, forecasting, financial management, and resource allocation.

• Proficient in Microsoft Office applications, including Word, Excel, and Project.

• Excellent communication, presentation, stakeholder management, and relationship-building abilities.

• Strong leadership, organizational, problem-solving, and decision-making skills.

• Capability to work efficiently in a collaborative, fast-paced, and results-oriented environment.

🏝️ Benefits

• Competitive compensation.

• Medical, dental, and vision insurance.

• Flexible and paid time off.

• Options for remote and hybrid work.

• Tuition reimbursement.

• Employee assistance and wellness programs.

• Life and disability insurance.