Job Opportunities at IQVIA

Job Overview
Perform monitoring and site management work for a variety of protocols, site and therapeutic areas.

Essential Functions

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Act as a mentor for clinical staff including conducting co-monitoring and training visits.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Qualifications

• High School Diploma or equivalent Degree in scientific discipline or health care preferred.
• Requires at least 3 years of year of on-site monitoring experience.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Strong therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

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JOB DESCRIPTION

IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, Technology, analytics and human ingenuity to drive healthcare forward.

We are looking for a dedicated Site Solutions Analyst to be based in Bloemfontein (South Africa) and be part of the Clinical Trial Payments unit in IQVIA. The Clinical Trial Payments department uses the most advanced site payment solution available and offers service to customers to integrate/centralize all payments in a high tech software. This position will be responsible for managing core financial data implementation for contracts with CRO´s, clinical sites, clients and investigators, overseeing the site reimbursement processes of invoicing and accounts payables. This position is also responsible for initial site set-up within the proprietary software systems, collection of site required documentation, start up and pass through payments, receives incoming enrolment data, conducts data review and completes necessary edits, management of the visit payment process and ensuring satisfaction.

Summary of Essential Job Functions:

• Review and document each site contract for input of site specific data into designatingtracking system, responsible forobtaining all critical information from client site.
• Manage client site banking information, responsible for integrity of electronic fundtransfer (EFT) data for the life ofthe contract for processing of invoicing and payments.
• Responsible for requesting advance payments and processing of pass-through payments.
• Responsible for communicating with client sites in the normal processing of pass-through payments.
• Responsible for data integrity of contract terms as it is entered into designated systemsin accordance with project requirements.
• Managing site inquiries escalated fromCustomer Support and update cases in ourcase management system.
• Creation and tracking of proforma invoices for international client sites.
• Generates invoicing for client sites, verifying financial data accuracy prior to issuance of same.

Requirements:

• Minimum of 1 year's accounting, payment coordination or project finance experience.
• Bachelor's Degree in Finance or equivalent combination of education, training and experience.
• Fluent English skills is a must and any other language will be considered as a plus.
• Knowledge of revenue recognition, variance analysis, unbilled/unearned and cash flow management, and backlog forecasting.
• Knowledge of Peoplesoft Project.
• Experience with RPA or SAP or Power BI or Spot fire will be considered a plus.
• Good level of Microsoft Office applications.

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JOB DESCRIPTION

IQVIA Clinical Functional Services Partnerships (FSP) business is unique. Our teams are dedicated to a single sponsor partner, where the common goal is quality delivery for our customers.  We set ourselves apart with collaboration and face to face contact both at start up and during the clinical study.

Leadership recognises the skills, talent and experience of our clinical teams and strives to build upon this as the function evolves and grows.   Our managers understand the sponsors priorities and the individual aspects of each model.  Focus is given to career development from day one, including new hire orientation and onboarding, day to day problem solving and training and development.

Unique to the FSP model, our team contributes to the pipelines of the specific sponsor and therefore our CRAs are ‘indication and molecule experts’.  Additionally, IQVIA’s FSP business works with the Sponsors SOP’s, creating more continuity for both parties.

Our models offer excellent opportunities for experienced CRA’s to expand their knowledge and skills.

What we Offer:

• Excellent salary and benefits package
• Flexible working hours in an office-based or a home-based working models
• We invest in keeping our teams stable, so workload is consistent
• We offer genuine career development opportunities for those who want to grow as part of the organisation
• We give the chance to work on cutting edge medicines, right at the forefront of new medicine development

Role Details:

• Working in partnership with a single-sponsor
• Usually allocated to 2-3 protocols (likely to be in the areas of Oncology, Neurology, Immunology and/or Diabetes)
• Responsible for approximately 15 sites
• On site between 6 and 9 days per month, dependent on the sponsor
• All CRAs and SCRAs are allocated a dedicated IQVIA Line Manager
• Permanent employment contract
• Sponsor model has reduced travel (approx. 30% or less) due to using ‘the Risk-Based monitoring which incorporates remote monitoring therefore there is less need for on-site visits

Responsibilities:

• Site management and monitoring activities across South Africa
• Work with sites to adapt, drive and track subject recruitment plan
• Provide protocol and study training to the assigned sites
• Create and maintain monitoring visit reports and action plans
• If appropriate, co-monitor, train and mentor junior members of the team   

Become part of our team.

We believe in hiring the best talent in the industry.

To become part of our team, you should:

• Have a degree in Life Sciences or have equivalent experience within a nursing background.
• Have at least 2 years of independent on-site monitoring experience
• Be experienced in handling multiple protocols across a variety of drug indications with good time management skills
• Have in depth GCP knowledge
• Be flexible with the ability to travel nationwide
• Hold a full French and clean driving license
• Possess strong communication, written and presentation skills are a must (must have fluency in English)
• With the merger between Quintiles and IMS Health, we now have access to significant data pools allowing better site selection and recruitment. This helps drive performance of sites making the CRA role more efficient and discussions at site more productive. It’s the next generation of clinical development
• Whatever your career goals, we are here to ensure you get there!

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Job Overview
The manager Site Solutions oversees, supervises and manages the operational aspects of ongoing projects and programs of the Clinical Trial Payments department, ensuring quality deliverables on time and within budget.  Will ensure that all project work is completed in accordance with SOPs, policies and practices.  Manage staff in accordance with organization’s policies and applicable regulations.

Essential Functions

• Create, track and report on project timelines.
• Produce and distribute status, tracking and financial reports for internal and external team members and senior management.
• Coordinate with other project resources within and outside the organization.
• Responsibility for financial reporting on the project including tracking deliverables and invoicing.
• Monitor and manage efforts of cross-functional project teams.
• Mentors Project Coordinators.
• Meet with team members on a regular basis regarding project tasks to ensure project milestones are met.
• Lead problem solving and resolution efforts.
• Develop and maintain internal databases and project plans.
• Maintain project management information and tracking systems.
• Participate in proposal development and sales/proposal presentations.
• Manage project budgets and approval of invoices.
• Produce and distribute reports and presentation materials.
• Assist in supporting staff development.
• May have supervisory responsibilities for Project Managers including professional development, and mentoring
• Establish goals that will increase Project Manager knowledge and skill levels
• Implement continuous improvement activities for assigned projects
• Develop and oversee maintenance of internal databases and project plans.
• Partner with other Project Managers to develop and implement process improvements
• Prepare and present project information at internal and external meetings.
• Ensure that work is conducted in compliance with standard processes, policies and procedures and meets project timeline metrics.
• Trains new project Coordinators on process and procedure.
• Sets performance expectations with direct reports.
• Assists Director with department resourcing.
• Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on hum resources matters.

Qualifications

• Bachelor's Degree in Business Administration, Finance, Economics or similar.
• Seven (7) years of related experience or equivalent combination of education, training and experience.
• Strong software and computer skills, including MS Office applications.
• Excellent communication and interpersonal skills.
• Good problem solving skills.
• Demonstrated ability to deliver results to the appropriate quality and timeline metrics.
• Strong influencing and negotiation skills.
• Good team leadership skills.
• Excellent customer service skills.
• Sound judgment and decision making skills.