Medical Monitor & Safety Specialist at Xcene Research

Xcene Research is a cutting-edge Contract Research Organization providing full-service support to pharmaceutical, biotechnology and medical device companies as well as academic institutions. We offer a range of services that help companies get their new products to market, with a specific focus on vaccines, neglected tropical diseases, rare diseases, metabolic diseases, oncology, neurology, hematology, cardiovascular and medical device in Africa.

We are recruiting to fill the position below:

Job Title: Medical Monitor & Safety Specialist

Location: Lagos
Job Type: Full time

Job Purpose

• With participants’ safety and credibility of data as the primary focus of clinical research, Medical Monitors & Safety Specialists at Xcene Research collaborate with the Sponsor Central Statistical Monitor and Clinical Study Team to understand the study data and risk reports using available technology to monitor data quality, patient safety and relevant risks, they would be the first people to draft any study related risk/issue(s) and maintain the Risk Management Plan and tools.

Key Accountabilities

• Serves as the Medical Monitor (MM) & Safety Specialist (SS) for clinical trials, to address patient eligibility and treatment questions in cooperation with study investigators.
• Review’s safety data for routine medical data review, trend review, and safety signals from ongoing trials.
• Reviews serious adverse event (SAE) reports from ongoing clinical studies and work in close collaboration with investigators to review causality and develop reports (including narratives and analyses of similar events) for reportable SAEs.
• Participates in interpretation of data analyses of clinical trial results and developing clinical trial reports.
• Provides strategic and design input for clinical trials and clinical development plans.
• Provides input/review of clinical documents, e.g., protocols, investigator’s brochures, case report form design.
• Participates in site/investigator identification and evaluation for clinical trials, conduct site engagement calls and visits.
• Leads preparation of clinical sections of relevant regulatory filings (IND, study reports, NDA, etc.)
• Serves as program medical expert for internal and external collaborators, investigators, consultants, and contract resources.
• Represents the company at scientific meetings and presentations.
• Contributes to scientific affairs by authoring and / or reviewing abstracts, presentations and manuscripts for medical accuracy and content.
• Attends and provides medical support for investigator and consultant meetings (e.g., investigator meetings, clinical advisory boards).
• Develops and manage relationships with key opinion leaders for clinical programs.
• Independently maintains state of the art knowledge in the therapeutic area.

Knowledge and Experience:

• Must have thorough knowledge of clinical research concepts, practices, and FDA regulations,country localregulations, NAFDAC regulations, EU regulations and ICH Guidelines regarding drug development phases, clinical trials, clinical study design, and data/safety management methods.
• Expertise in safety matters with demonstrated ability to effectively manage multiple  and people.
• Proactive problem-solving abilities and follow-through.
• Ability to work in a very dynamic environment of scientifically driven biotech, with  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 safety team remains compliant with GCP and other global regulatory guidelines or laws.

Education and Qualifications

• Bachelor’s degree (or equivalent) level of qualification in Medicine or equivalent combination of education and experience.

Skills:

• Effective communicator (written and presentation) with good interpersonal skills and experience in developing and delivering presentations.
• Ability to work across cultures and geographies with a high awareness and understanding of cultural differences.
• Technical ability to use the relevant technology and risk-based tools/platforms effectively.

Application Closing Date
Not Specified.