Jobs/Vacancies
At IQVIA Nigeria, hiring
IQVIA is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
We are recruiting to fill the position below:
Job Title: Quality Control Reviewer
Job ID: R1453713
Location: Nigeria
Job type: Full-time
Job Overview
- Performs quality control review of Medical Writing deliverables from internal and external authors to ensure accuracy, consistency, and compliance with format and style requirements
Essential Functions
- Conduct quality control (QC) review of a wide range of Medical Writing deliverables for both internal and external customers, including complex and substantial documents, with limited guidance and consistent high quality and efficiency;
- Document findings clearly, in accordance with defined procedures and checklists;
- Liaise promptly with document authors in case of questions or missing sources ;
- Provide service metrics and scores, as required;
- Develop quality tools such as checklists, quality guidelines, standards and scoring methodology to meet project specific needs;
- Identify quality issues and assist management team in implementing solutions;
- May provide training, guidance, and/or mentoring reviews to junior colleagues or explain QC processes to team members or customers;
- May propose revisions to standard operating procedures (SOPs) related to QC review or suggest process improvements for consideration;
- Contribute learnings to team meetings and help in improving overall quality of document delivery;
- May participate in project team meetings and liaise directly with the customer on QC issues, as appropriate and with senior support as needed;
- Take responsibility for on-time delivery of QC review comments;
- Manage daily assignments, planning and directing work, and take responsibility for managing workload for assigned projects and tasks, in collaboration with senior staff;
- Keep abreast of current data, trends, medical writing (MW)/regulatory knowledge, developments and advances in area of drug development/MW.
Qualifications
- B.Sc. Degree in Life Science-related discipline or related field
- Typically, at least 4 years’ experience working with clinical trial documentation in a research environment, including significant experience of performing QC review of clinical trial-related documents
- Careful attention to detail, accuracy, and consistency;
- Impeccable English language skills and ability to detect and correct grammatical, spelling, and language errors;
- Ability to understand scientific/medical documents and identify deficiencies, errors and inconsistencies;
- Familiarity with the structural and content requirements of clinical study reports, protocols, and similar documents;
- Proactivity and advanced organizational and time management skills and ability to prioritize workload effectively with commitment to deadlines;
- Ability to communicate clearly, concisely, and effectively in English, both in writing and verbally, and confidence in using a range of communication methods to achieve results;
- Good understanding of clinical drug development and the functions, steps, and processes involved;
- Advanced understanding of the nature and purpose of Medical Writing deliverables;
- Ability to provide thorough, appropriate, and sensitive feedback to less experienced colleagues;
- Confident use of Microsoft Office and Adobe Acrobat;
- Ability to quickly establish and maintain effective working relationships with co-workers, managers, and customers at a range of seniority levels.
Application Closing Date
Not Specified.
How to Apply
Interested and qualified candidates should:
Click here to apply online
Job Title: Site Monitor Educator – Nigeria
Job ID: R1450935
Location: Nigeria
Employment type: Full time
Role Type: 6-month contract with a phased-work schedule
Description
- The Site Monitor Educator is responsible for overseeing and coordinating the activities of site monitors to ensure the successful execution of clinical trials.
- This role involves ensuring compliance with regulatory requirements, Good Clinical Practice (GCP), and company standards.
- The Site Monitor Educator will act as a liaison between the clinical trial sites and the sponsor, providing guidance and support to site monitors and ensuring the integrity and quality of the data collected.
Key Responsibilities
Leadership and Supervision:
- Ensure that site monitors adhere to study protocols, regulatory requirements, and company SOPs.
- Coordinate and oversee site monitoring activities to ensure timely and accurate data collection.
Site Management:
- Develop and maintain strong relationships with clinical trial sites.
- Conduct site visits to ensure compliance with study protocols and regulatory requirements.
- Address and resolve any issues or concerns raised by site monitors or clinical trial sites.
Monitoring:
- Monitoring will entail review of Informed Consent Forms, data entry on the RWE Box folder, Trial master file and source documents.
- Post monitoring of the sites, Site Monitor Lead is to complete site visit reports, File notes and CAPAs and do site retaining as needed.
Quality Assurance:
- Review and approve monitoring reports to ensure accuracy and completeness.
- Implement quality control measures to ensure data integrity and compliance with GCP.
- Conduct regular audits of site monitoring activities and provide feedback for improvement.
Regulatory Compliance:
- Ensure that all site monitoring activities comply with applicable regulatory requirements, including ICH guidelines.
- Site Monitor Educatory to complete regulatory reports and submit to regulatory bodies as required.
- Stay updated on changes in regulatory requirements and industry best practices.
Communication and Collaboration:
- Serve as the primary point of contact between the sponsor and clinical trial sites.
- Facilitate effective communication and collaboration between site monitors, clinical trial sites, and other stakeholders.
- Provide regular updates to the Clinical Operations Manager on the status of site monitoring activities.
Qualifications
- Bachelor’s Degree in Life Sciences, Nursing, or a related field. Advanced degree preferred.
- Minimum of 5 years of experience in clinical research, with at least 2 years in a supervisory or lead role.
- In-depth knowledge of GCP and ICH guidelines.
- Ability to travel as required.
Skills:
- Ability to create and implement effective training programs.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Strong understanding of pharmacology and medication therapies.
- Excellent communication and interpersonal skills.
- Proficient in delivering engaging and informative presentations.
- Ability to explain complex medical information clearly and effectively.
- Strong analytical and problem-solving skills.
- Attention to detail and ability to work independently.
- Ability to manage multiple priorities and meet deadlines.
Application Closing Date
Not Specified.
How to Apply
Interested and qualified candidates should:
Click here to apply online
Job Title: Senior Quality Specialist, West Africa
Job ID: R1445140
Location: Nigeria
Job type: Full-time (Remote)
Job Description
- This position is not suitable for a candidate with Quality Assurance experience in a manufacturing/factory/industry setting. We require experience in Clinical Quality Management gained at a CRO. Experience as a CRA is essential.
Job Overview
- This role is assigned to designated Delivery Unit(s), sponsor(s), business line(s), and/or specific tasks as defined by the line manager (LM).
- The purpose of this role is to carry out and adopt the global Quality Plan according to the specific needs defined by the scope of the assignment, to assist the assigned business line staff in improving compliance with relevant International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), Key Performance Indicators (KPIs), applicable regulatory requirements, and guidelines.
- Contribute to the development and be responsible for the implementation of specific quality improvement initiatives as agreed with the management and the relevant Head(s) of assigned business lines.
- Provide advice and support to relevant key stakeholders with regards to quality control, risk assessment, risk management, and corrective/preventive actions.
Essential Functions
- Adopt and implement the global Quality Management Plan within the scope of the assignment; this will include:
- Planning and executing the Quality Management activities.
- Risk identification and assessment through data review and quality control processes.
- Providing support in risk mitigation, in planning corrective/preventive actions, and guidance for improvement.
- Supporting the assigned business line management and staff to enhance effectiveness.
- Cooperate closely with the relevant business and other stakeholders, support maintaining focus on quality in project delivery.
- Contribute to the development and implementation of a Delivery Unit/Sponsor specific Quality Management plan and Risk Management Program, monitor the implementation and delivery.
- Provide advice and support to teams within the assigned business line and other key stakeholders on all aspects of Good Clinical Practice (GCP) compliance.
- Work in close cooperation with teams to manage non-compliance, quality issues, assist in planning corrective/preventive actions, as applicable according to SOPs.;
- Inform the assigned business line and Quality Assurance of quality issues according to SOPs.
- Work closely with Quality Assurance and assigned business staff in case of suspected misconduct, as required by the applicable SOPs.
- May provide assistance during audits and regulatory inspections to the teams to the extent agreed, as required by the applicable SOPs.
- Prepare periodic reports to stakeholders on quality related matters, risk assessments and specific quality improvement initiatives.
- Upon agreement the line manager: Perform any other reasonable tasks as required by the role.
Qualifications
- Candidates should possess a Bachelor’s Degree in Life Sciences or similar field.
- 3 years experience in Clinical Monitoring, including at least 2 years’ experience in a role 3 years’ experience equivalent to a Clinical Project Manager/Clinical Team Lead, preferably within IQVIA.
- Clinical Research experience gained in a Clinical Research Organization essential.
- Previous experience as a Clinical Research Associate (CRA) essential.
- Sound working knowledge of medical terminology, International Conference on Harmonization (ICH), Good Clinical Practice (GCP), applicable regulatory requirements, quality management processes.
- Knowledge of National and International Regulations and Drug Development processes.
- Knowledge of Pharmaceutical industry operations.
- Good organizational, interpersonal and communication skills. Good judgement and decision-making skills.
- Strong influencing and negotiation skills.
- Strong computer skills including Microsoft Office applications.
- Excellent problem-solving skills.
- Ability to travel within the region/country.
- Ability to lead and motivate a team.
- Ability to establish and maintain effective working relationships with co-workers, managers and clients/customers.
- Fluent in English.
Application Closing Date
Not Specified.
How to Apply
Interested and qualified candidates should:
Click here to apply online
Job Title: Medical Writer
Job ID: R1453737
Locations: Nigeria
Job type: Full-time
Job Description
Job Family Description:
- Writes, reviews, and coordinates technical documentation regarding clinical trials in line with client specifications and industry practices.
Sub-Family Description:
- Prepares, or contributes to the preparation of clinical and/or regulatory documents, for either internal customers or external clients, for investigational drugs, biologicals, or medical devices.
- Collaborates with internal and/or external experts and specialists; maintains expertise on developments in a particular field of focus.
Job Overview
- Acts as a Lead Medical Writer on projects. Prepares assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements as well as to the agreed timelines.
- Negotiates timelines and discusses/resolves customer comments, with senior support as needed.
- Keeps abreast of current medical and/or technical writing/regulatory knowledge, including GCP, along with developments and advances in drug development/medical and/or technical writing.
Essential Functions
- Take a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating and adhering to timelines, organizing document reviews, communicating directly with the customer.
- Manage day-to-day workload: identify project needs, track timelines and implement customer requests, keeping manager/senior staff abreast of progress on tasks and any potential problems with project work.
- Attend project team meetings with or without other writers. Participate in/lead comments resolution or similar meetings with external customers.
- May give presentation to an existing customer (e.g. on processes at a Kick-off meeting).
- Complete project finance activities, including monitoring and forecasting budgeted hours.
- Awareness of budgets and project finance principles, moving towards review and understanding of budgets relating to assigned projects, including out of scope activities.
Qualifications
- B.Sc. Degree in Life Sciences related discipline or related field.
- Typically requires 1-3 years of prior relevant experience and related competency levels.
- Familiarity with the structural and content requirements of clinical study reports, protocols, and similar documents.
- Good understanding of common statistical methods used in clinical trials and/or interpretation of their results.
- Ability to effectively review a statistical analysis plan and to identify deficiencies, errors, and inconsistencies in statistical output
- Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner.
- In depth knowledge of drug development, medical writing, and associated regulations.
- Good understanding of statistical principles and of medical terminology across a range of therapeutic areas.
- Excellent written and verbal communication skills including grammatical/technical writing skills.
- Excellent attention to detail and accuracy.
- Communicates clearly, effectively and confidently with others.
- Demonstrated abilities in collaboration with others and independent thought.
- Demonstrates confidence and maturity in most routine medical writing situations.
- Demonstrates good judgement in requesting input from senior staff.
- Ability to establish and maintain effective working relationships with coworkers, managers and customers.
- Ability to effectively manage multiple tasks and projects.
- Must be computer literate.
Application Closing Date
Not Specified.
How to Apply
Interested and qualified candidates should:
Click here to apply online
