Andrew Mogaila

• Conducted independent site management and performed onsite and remote monitoring activities.
• Ensured that the studies conduct at investigator sites were conducted as per ICH GCP;SA GCP; local regulatory and ethics rules and standards as well as the protocols and sponsor SOPs
• Completed monitoring reports timeously and maintained study files (e.g. ISF, TMF) in a continuous manner
• Balanced sponsor generated queries and ensuring they were resolved in a timely manner by investigator sites as per clinical monitoring plan.
• Assumed complete responsibility for the studies cost-efficiency

• Maximized efficiency by coaching and mentoring personnel on management principles, industry practices, company procedures, and technology systems.
• Implemented operational strategies and effectively built customer and employee loyalty.
• Managed budget implementations, employee evaluations, and contract details.
• Drove year-over-year business growth while leading operations, strategic vision, and long-range planning.
• Developed and maintained relationships with customers and suppliers through account development.
• Involved in new Business Development
• Ensured constant operational and training compliance to the industry government environmental affairs regulatory requirements

• Performed site management and routine monitoring activities at investigator sites to ensure compliance to the ICH GCP; SA GCP; local regulatory and ethics laws and standards as well as to protocols and sponsor SOPs.

• Maximized efficiency by coaching and mentoring personnel on management principles, industry practices, company procedures, and technology systems.
• Implemented operational strategies and effectively built customer and employee loyalty.
• Managed the day-to-day operational and administrative
  functions of the business to ensure effectiveness and
  efficiency in trading for improved profitability
• Involved in new Business Development and development of the marketing strategies of the organization
• Negotiated and closed deals with identified key customers

• Participated in site selection process, evaluated site capabilities and made recommendations for inclusion or exclusion in clinical trials
• Compiled Investigator Site Files and Site Master Files in consistent with Trial Master Files
• Performed site management and routine monitoring activities to ensure continual compliance with SA GCP, ICH, local regulatory and ethics rules and standards as well as to sponsor SOPs and assigned protocols.
• Reported and escalated deviations timeously to relevant stakeholders during trial conduct and instituted remedial action and re-training where and when necessary

• Performed Monitoring duties for an HIV study at assigned Investigative sites to ensure the trial is conducted in accordance with the international and local regulatory rules and standards (e.g., SA GCP, ICH-GCP, local regulatory body and ethics committees). This included among others source data verification; timely reporting of SAEs and reporting of incidences of non-compliance to the protocol to relevant stakeholders

• Used consultative sales techniques to understand customer needs and recommend relevant products and services.
• Created detailed sales presentations to communicate product features and market data.
• Cold called and conducted face-to-face sales calls with C-level executives and directors in assigned sales territory.
• Fulfilled orders and sourced products to meet rigorous customer delivery schedules.
• Identified and developed new markets (Orthopaedic and cranio maxillofacial surgeons) for a regenerative medicine development product (i.e. Bone Morphogenetic Proteins-BMP)
• Educated and informed the target market about the use of the innovative BMP technologies in bone tissue regeneration
• Trained the target market about the correct application and reconstitution of the company’s medical device (bone auto graft substitute) during surgical operations in theatre

• Planned, organized. led and coordinated a nutritional tree plantation project in impoverished village communities for self-sustainability and self-reliance economically
• Identified and negotiated the local and export markets for the product to sell to.

• Performed site management and routine interim monitoring activities to ensure compliance to ICH GCO; SA GCP, assigned protocols and sponsor SOPs
• Used judgemental experience to evaluate overall performance of sites and sites' staff, and provided recommendations regarding site-specific actions. Immediately escalated serious issues and developed corrective action plans
• Assessed site processes and conducted source data review of appropriate source documents and medical records
• Verified required clinical data entered in e-CRF is accurate and complete

• Prepared and reviewed study documentation (ISF and TMF)
• Conducted feasibility studies, site selection, site initiation, interim routine monitoring activities, site management and site close-out visits for assigned clinical studies.
• Verified that the process of informed consent has been obtained adequately and well documented for each study participant
• Involved in training and mentoring of fellow junior CRAs as a lead CRA
• Verified that required clinical data entered in e-CRF is accurate and complete via review of site source documents and medical reports

• Arranged appointments with doctors, pharmacists and medical teams to raise awareness of latest product launches.
• Recognized trends within assigned sales territory and create proactive plans to improve market shares of allocated marketed medicinal products
• Detailed to and educated general practitioners and specialist physicians (in private practices and private hospitals) marketed products with the sole objective to effect sales and increase the market shares in allocated sales territories
• Planned, organized and coordinated Continual Professional Development (CPD) meetings for the doctors with the objective of educating them on the new treatment approaches for applicable therapeutic area, with the objective of effecting sales for our marketed products
• As as junior CRA, performed site management and conducted routine monitoring activities, including site initiation and site-close-out visits

As a product development chemist:

• Involved in new detergent products formulations and re-formulation of existing marketed products for cost-efficiency and effectiveness
• Performed quality tests (efficiency and effectiveness) on new formulations in the laboratory before large production in the factory
• Kept abreast of new trends and developments in the chemical industry to adapt the organizational goals and objectives in terms of product innovation
• Conducted customer visits and onsite demonstrations on the correct application of our marketed products for best results

As QC/QA Microbiologist:

• Checked and verified that the microbiological contamination of finished products was within the SABS standards and specifications before they were packaged and delivered to intended customers. If not to give advices and recommendations to the factory to correct the batch to meet the applicable specifications.
• Conducted regular long-term storage and stability tests of finished products