Job Opening ID 235 Location Lagos Industry Consulting Work Experience 7-10years City Lagos, Nigeria Province Lagos Postal Code 0000
A client company is looking for an experienced Medical Officer with in-depth knowledge in operations, project initiation, execution and closeout.
He / She would perform a wide variety of activities to support the start-up and completion of clinical research studies and may supervise other clinical operations personnel.
Balance the duties of a physician with that of an administrator.
Ensure that patients receive the highest standard of medical care.
Being responsible for the performance of physicians under your supervision.
Ensure that all healthcare regulations and safety standards are met.
Keep staff updated on new healthcare regulations.
Find ways to improve clinical services.
Liaise between administration and medical staff.
Report to the Chief Executive Officer or Board of Directors.
Recruit and mentor physicians.
Develop and manage a hospital budget.
Achieve study objectives by working with team members to set project priorities and milestones and resolve project conflicts
Assess the operational feasibility of studies and recommends execution and risk mitigation plans
Develop and track study timelines, budget, and quality metrics
Ensure appropriate clinical resources are available for the clinical project
Ensure GCP and regulatory compliance is maintained
Lead the development of study-related documents, including study protocols, informed consent documents, study manuals and plans, trial master files, case report form design, etc.
Maintain professional expertise through familiarity with therapeutic area and clinical research literature
Manage clinical projects from concept through clinical study report completion
Oversee clinical research study conduct
Manage, mentor and develop direct reports
Organize and lead the clinical project team.
Lead regularly scheduled cross-functional study team meetings with internal and external resources
Participate in CRO and other vendor selection, negotiation and management, including monitoring of associated budgets and contracts
Participate in meetings with investigative sites, key opinion leaders and consultants as needed
Play a part in the analysis, summary, and reporting of clinical data through the course of the study
Aide in the training and development of all clinical staff members
Proactively identifies and resolves issues, and participates in process improvement initiatives as required
Respond promptly and appropriately to study questions and issues raised by investigative sites, vendors, monitors, and consultants
Review and approves invoices from study vendors, investigators, consultants, etc.
Evaluate monitoring reports with significant findings to confirm appropriate conclusions and actions taken
Review serious adverse events and other pertinent data with the medical monitor and drug safety personnel to identify safety trends and potential risks
Perform other duties as assigned
Medical Degree / Bachelor’s and / or master’s degree in a scientific discipline, RN, BSN degree or Health Administration (MHA) or Master of Business Administration (MBA) equivalent will be advantageous.
Valid medical license.
8+ years’ clinical experience.
5+ years operations cum project-lead or management experience
Conscientious, influential person with an outstanding work ethic and strong personal discipline
Clinical risk management experience.
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