Clinical Trial Project Manager

2 weeks ago

England, UK, United Kingdom Xcene Research Full time

Company Description

Xcene Research is a pioneering Contract Research Organization (CRO) located in Lagos, Nigeria, specializing in the management, execution, and analysis of clinical trials ranging from Phase I through Phase IV, including small to complex multinational trials. We offer services in various therapeutic areas, including vaccines, neglected tropical diseases, rare diseases, metabolic diseases, oncology, neurology, hematology, cardiovascular, and medical device. Trust, uncompromised quality, optimal communication, and timely performance are the core values of Xcene Research.

Join us at Xcene Research and be a part of a dynamic team that is driving innovation, advancing healthcare, and making a significant impact on the future of medical research in Africa and beyond.

Role Description

The Clinical Trial Project Manager will be responsible for managing, planning, and executing clinical trials. The role includes tasks such as protocol development, site management, patient recruitment, project management, clinical trial monitoring, and quality compliance. In addition to managing the day-to-day operations of the trial, a CTPM is also responsible for ensuring that the trial is conducted in compliance with regulatory standards. This includes adhering to Good Clinical Practice (GCP) guidelines, which outline the ethical and scientific principles for conducting clinical trials. The position offers a mix of on-site work and the flexibility to work remotely as needed.

Responsibilities:

  • Achieves study objectives by working with team members to set project priorities and milestones and resolve project conflicts.
  • Owns the sponsor relationship and is responsible for sponsor communication.
  • Optimizes processes for projections including cost, enrolment, and Investigational Product forecasting.
  • Implements standardized project plans and planning processes.
  • Implements an efficient contracting and vendor selection process.
  • Establishes efficient vendor management processes.
  • Establishes standardized metrics and optimal reporting formats.
  • Develops and maintains SOPs and work practices applicable to a global organization.
  • Periodically reviews processes across clinical trial projects to ensure compliance and consistency.
  • Participates in, or leads, infrastructure development project teams to enhance department growth.
  • Lead strategic level work (e.g., partnership collaboration meetings, etc.
  • Provides a central point of study contact and single point of escalation on behalf of the functional teams (clinical, data management, biostatistics, medical writing, logistics, contracts, finance, medical and pharmacovigilance).
  • Proactively communicates with the sponsor and internal groups ensuring that they have all the information required on project progress and status (risk analyses, what-if scenarios, contingency plans, technical information, significant changes of any kind, etc.).
  • Provide proactive decisions /solutions and how the project objectives are being, or should be, achieved.
  • Prioritize effectively and respond to urgent requests within team or from sponsor.
  • Maintain a positive, results-orientated work environment, building partnerships and modelling teamwork, communicating to the team in an open, balanced, and objective manner.
  • Lead team meetings on a regular basis with project team.
  • Lead regular meetings/calls with sponsor to ensure they are fully informed of project progress, proactive decisions/solutions and how the project objectives are being achieved.
  • Communicate fiscal, contractual, resource, deliverable, and sponsor-related issues to management as appropriate.
  • Accountable for sponsor satisfaction as measured by client survey responses and repeat business.
  • Support with pre-award activities, including presentations and meetings.

Knowledge and Experience:

  • 5+ years project-lead or management experience
  • Must have thorough knowledge of clinical research concepts, practices, and FDA regulations, country local regulations, EU regulations and ICH Guidelines regarding drug development phases, clinical trials, clinical study design, and data management methods.
  • Expertise in clinical operations with demonstrated ability to effectively manage multiple projects, people, negotiate budgets, timelines, and responsibilities.
  • Proactive problem-solving abilities and follow-through.
  • Ability to work in a very dynamic environment of scientifically driven biotech, with limited resources and able to plan and execute simultaneously, as well as ability to evaluate and resolve complex problems.
  • Self-motivated to maintain expertise in quality and GCP requirements and guidance to ensure that the clinical operations remain compliant with GCP and other global regulatory guidelines or laws

Education:

  • Medical/Bachelor’s degree and/or master’s degree (or equivalent) level of qualification in a scientific discipline, RN, BSN degree and equivalent combination of education and experience.

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