Job Summary

We are seeking for an experienced project manager to join our team.

  • Minimum Qualification: Degree
  • Experience Level: Senior level
  • Experience Length: 4 years

Job Description/Requirements

Job Description


The ideal candidate will be responsible for planning, coordinating, and implementing projects within the decided-upon budget, timeline, and scope. They will also effectively monitor and present project updates to relevant stakeholders, clients, or project team members. 


Responsibilities

  • Achieves study objectives by working with team members to set project priorities and milestones and resolve project conflicts
  • Assesses the operational feasibility of studies and recommends execution and risk mitigation plans
  • Co-monitors as needed
  • Develops and tracks study timelines, budget, and quality metrics
  • Ensures appropriate clinical resources are available for the clinical project
  • Ensures GCP and regulatory compliance is maintained
  • Leads the development of study-related documents, including study protocols, informed consent documents, study manuals and plans, trial master files, case report form design, etc.
  • Maintains professional expertise through familiarity with therapeutic area and clinical research literature
  • Manages clinical projects from concept through clinical study report completion
  • Oversees clinical research study conduct
  • Manages, mentors, and develops direct reports
  • Organizes and leads the clinical project team. Leads regularly scheduled cross-functional study team meetings with internal and external resources
  • Participates in CRO and other vendor selection, negotiation and management, including monitoring of associated budgets and contracts
  • Participates in meetings with investigative sites, key opinion leaders and consultants as needed
  • Plays a part in the analysis, summary, and reporting of clinical data through the course of the study
  • Aides in the training and development of all clinical staff members
  • Performs other duties as assigned
  • Proactively identifies and resolves issues, and participates in process improvement initiatives as required
  • Responds promptly and appropriately to study questions and issues raised by investigative sites, vendors, monitors, and consultants
  • Reviews and approves invoices from study vendors, investigators, consultants, etc.
  • Evaluates monitoring reports with significant findings to confirm appropriate conclusions and actions taken
  • Reviews serious adverse events and other pertinent data with the medical monitor and drug safety personnel to identify safety trends and potential risks

Job Requirements:

  • 5+ years project-lead or management experience
  • Medical Degree/Bachelor’s and/or master’s degree in a scientific discipline, RN, BSN degree or equivalent
  • Conscientious, influential person with an outstanding work ethic and strong personal discipline
  • Excellent organizational, leadership and problem-solving skills
  • Excellent written and verbal communication skills
  • Experience in leading cross-functional teams to meet goals and metrics
  • Proficient computer skills, specifically with Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook)
  • Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management
  • Willing and capable to manage multiple projects, negotiate budgets, timelines and responsibilities
  • Working knowledge of MS Project for development and update of clinical study timelines

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