Job Type: Full-Time

Position Summary: The Project Manager – Healthcare and Clinical Trials will oversee and manage clinical research projects from inception to completion, ensuring they are completed on time, within budget, and in compliance with all regulatory requirements. The role requires a strong understanding of clinical trial processes, excellent organizational skills, and the ability to lead and motivate cross-functional teams.

Key Responsibilities:

• Project Planning: Develop comprehensive project plans that outline the scope, goals, deliverables, resources, budget, and timelines for clinical trials.
• Team Leadership: Lead and coordinate multidisciplinary project teams, including researchers, clinicians, data analysts, and external partners, to ensure project objectives are met.
• Regulatory Compliance: Ensure all clinical trials are conducted in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines, and company policies.
• Budget Management: Oversee project budgets, including forecasting, tracking expenses, and ensuring cost-effective use of resources.
• Risk Management: Identify potential project risks and develop mitigation strategies to address them proactively.
• Communication: Serve as the primary point of contact for project stakeholders, providing regular updates on project status, milestones, and any issues that arise.
• Documentation: Maintain accurate and detailed project documentation, including study protocols, informed consent forms, regulatory submissions, and progress reports.
• Quality Assurance: Ensure the quality and integrity of clinical trial data through regular monitoring, audits, and adherence to standard operating procedures (SOPs).
• Training: Provide training and support to project team members on clinical trial processes and regulatory requirements.

Qualifications:

• Education: Bachelor’s degree in life sciences, healthcare administration, project management, or a related field. A Master’s degree or PMP certification is preferred.
• Experience:
  • Minimum of 3-5 years of experience managing clinical trials or healthcare projects.
  • Proven track record of successfully managing multiple projects simultaneously.
• Knowledge:
  • In-depth understanding of clinical trial design, conduct, and regulatory requirements (e.g., FDA, EMA).
  • Familiarity with clinical data management systems and electronic data capture (EDC) systems.
• Skills:
  • Excellent organizational and time management skills.
  • Strong leadership and team management abilities.
  • Effective communication and interpersonal skills.
  • Proficiency in project management software (e.g., MS Project, Asana, Trello).
  • Analytical and problem-solving skills with attention to detail.
• Certifications: PMP (Project Management Professional) or equivalent certification is preferred.
• Other Requirements:
  • Ability to work independently and as part of a team.
  • Willingness to travel as needed.

Application Process: Interested candidates should submit their resume and a cover letter outlining their qualifications and experience to contact@akh-consult.com

Equal Opportunity Employer: AKH-Consult is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.