Job Description

Job Title: Clinical Research Project Manager

Job Summary:

The Clinical Research Project Manager will oversee the planning, execution, and completion of clinical research projects, ensuring they are delivered on time, within scope, and within budget. This role involves managing cross-functional teams, coordinating with stakeholders, and ensuring compliance with regulatory requirements and organizational standards. The ideal candidate will have strong leadership, organizational, and communication skills to effectively manage all aspects of clinical trial operations.

Responsibilities

• Plan and manage clinical research projects, including defining project scope, objectives, timelines, and deliverables.
• Develop and maintain comprehensive project plans, ensuring alignment with organizational goals and study protocols.
• Coordinate and oversee activities of cross-functional teams, including clinical operations, data management, regulatory affairs, and external vendors.
• Monitor project progress and performance, ensuring adherence to budgets, timelines, and quality standards.
• Identify and mitigate project risks, developing contingency plans as needed.
• Serve as the primary point of contact for sponsors, investigators, and other stakeholders, providing regular updates on project status.
• Ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and company policies.
• Oversee site selection, initiation, monitoring, and close-out activities, ensuring sites meet performance expectations.
• Manage and track project budgets, invoices, and financial reporting.
• Prepare and present project reports to senior management and stakeholders.
• Foster strong relationships with clinical sites, investigators, and other external partners.

Qualifications

• Bachelor’s degree in a life science, healthcare, or related field (Master’s degree preferred).
• At least 5 years of experience in clinical research, with a minimum of 2 years in project management.
• In-depth knowledge of clinical trial processes, GCP, and regulatory requirements (e.g., FDA, EMA).
• Proven ability to manage multiple projects simultaneously in a fast-paced environment.
• Strong leadership and team management skills with the ability to motivate and guide cross-functional teams.
• Excellent organizational, analytical, and problem-solving skills.
• Proficiency in project management tools and software.
• Exceptional written and verbal communication skills.

Preferred Skills:

• Certification in project management (e.g., PMP, PRINCE2) or clinical research (e.g., ACRP, SOCRA).
• Experience in specific therapeutic areas relevant to the organization’s research focus.

Please send resumes to Delanda@Machaondiagnostics.com

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