Local Trial Manager based in Riyadh, Saudi Arabia (R1110140) in Riyadh, Saudi Arabia at IQVIA™

Date Posted: 3/19/2020

Job Snapshot

  • Employee Type:
    Full-Time
  • Experience:
    Not Specified
  • Date Posted:
    3/19/2020
  • Job ID:
    R1110140

Job Description

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.

Role Summary: Manage the execution of the assigned clinical studies, from initiation through to

closeout. Ensure that all clinical study management and project deliverables are completed, ensuring

quality deliverables on time and in accordance with SOPs, policies and practices.

Responsibilities:

1. Study planning activities

Site identification

• Perform country and site feasibility and summarize the information in a Country Feasibility

Report

• Review and sign-off Pretrial Assessment Report and ensure follow-up and resolution of all

items identified

Investigator contracting

• Create and negotiate the Clinical Trial Agreement with the investigators

• Provide the GTM with the initial study budget in liaison with local management

2. Study start-up activities

Site start up

• Create local country recruitment and study plan, including key timelines and monitoring

frequency, communicate to local team and/or to GTM and ensure that it is adhered to

• Ensure that current versions of trial documents that are listed on the Site Initiation Report and

all required trial-related materials and supplies are provided to the investigational site by the

site manager

• Set up the LAF

• Prepare a country-specific ICF and, if applicable, a pharmacogenomic country-specific ICF in

the local language(s) and ensure that the final draft of this document and if applicable site

specific ICF is reviewed and approved by the local affiliate

• When applicable, ensure that a Coordinating Investigator is selected and informed of his/her

responsibilities

• Ensure that the central IEC/IRB (or in case of local IRB through site manager) is provided

with current and complete copies of all documents that the IEC/IRB requests to fulfill its

obligation and obtain a copy of the valid written IEC/IRB approval and all related required

documents, including the composition of the IEC/IRB

• Ensure that local RA approval and import/export licenses (if applicable) are obtained

• Provide Responsible SUA Contact Person and/or LSO as applicable with trial information.

• Provide a copy of the Safety Monitoring Plan to the LQD

• Ensure trial is set-up in GCOSU and required information provided in line with the option

chosen in service agreement

• Review and where applicable approve trial drug related documents (including CTSP and

country specific label)

• Provide completed 1572 Forms and related required documents to GTM and request 1572

Form waiver letter if applicable

• Ensure that valid Insurance Certificate is in place

• Ensure that relevant sponsor personnel (SM, CTA) are properly trained on all relevant

aspects of the trial

• Schedule and conduct local Investigator Meeting if applicable

• Review the Site Initiation Report for completeness, sign off and ensure follow up and

resolution of all the items identified

Vendor and partner start-up

• Perform UAT on trial related external systems and related manuals (such as IVRS) if

applicable

• Verify that IVRS is operational for the country

• Verify that all predefined specifications are met in terms of functionality, reporting &

interaction with other vendors

• If applicable, identify local vendors, create and negotiate agreement with these vendors

• Ensure that country-specific requirements for sample handling can be met and that the SMs

are properly trained in these requirements

3. Study execution activities

Site management

• Notify the GTM (and local CSU if applicable) when the country and an investigational site is

approved to receive clinical drug supplies

• Ensure shipment of drug and non-drug supplies is arranged and monitor the process for the

need for additional drug and non-drug supplies as well as relabeling of study drugs or drug

transfer if required

• Ensure that all relevant trial related documentation is provided to investigators, central IEC (if

applicable) and regulatory authorities (if applicable) during the trial within required timelines

• Ensure distribution of SUAs and other Safety Reports in line with the service agreement

option

• Where applicable, ensure the LSO and /or the responsible local SUA contact person are

informed of all relevant safety information for submission to relevant Regulatory Authorities

• Ensure that SAEs, pregnancies and PQCs are reported within reporting timelines and

according to established procedure

• Maintain LAF

• If updated ICF versions are issued during the trial, prepare a country-specific ICF and, if

applicable, an ICF addendum and pharmacogenomic country-specific ICF in local

language(s). Ensure that the final draft(s) and if applicable site specific ICFs are reviewed

and approved by the local affiliate

• Ensure any updates to 1572 Form and related required documents are provided to GTM

during the trial

• Implement and track country recruitment strategies and provide updates to GTM and SM

• Co-ordinate monitoring and ensure monitoring frequency

• Review the Monitoring Visit Reports for completeness, sign off and ensure follow up and

resolution of all the items identified

Vendor and partner management

• Follow up on correct use of the IVRS system during the trial

Budget and resources

• Track costs at country level. Update country budget when necessary and provide to GTM

4. Study close out activities

Site closure

• Ensure that the IEC/IRB and regulatory authorities are notified of country and global trial

completion and are provided with the required documents

• Inform Responsible SUA Contact Person and /or LSO when SUA distribution can be

discontinued

• Review the Site Closure Report for completeness, sign off and ensure follow-up and

resolution of all items identified, including adverse events and IFDF's one year post-trial

Vendor and partner management

• Ensure vendors are notified and systems updated when all sites in the country have been

closed

Budget and resources

• Reconcile country budget and all vendor agreements

Trial documentation

• Ensure that the LAF is complete and accurate. Forward the IFs and LAF to the Local

Archiving Coordinator for archiving

• Ensure appendix 1 documents are completed and forwarded to the GTM Clinical Trial

Assistant

5. General activities

• Represent the company and the organization adequately to the customers and other external

parties

• Base all actions on Credo

• Protect the rights of others, protect privacy and company assets, particularly information as

the key asset

• Conduct business in line with the HCC, company policies and procedures, including

applicable SOPs, always having the ethical aspect in mind

• Maintain adequate communication with relevant parties within and outside the company

• Comply with ICH-GCP and all applicable local laws and regulations

• Actively follow trainings to ensure adequate qualification for performing job-related tasks

• Report (suspicion of) fraud or scientific/ethical misconduct as appropriate

• Regularly update information in applicable systems and templates

• Maintain quality standards and timelines that are consistent with business needs

*This is not an exhaustive, comprehensive listing of job functions and tasks. Other duties may be

performed as assigned and agreed upon with Quintiles management.

Qualifications:

• Computer literacy required, including well-developed computer skills in MS Word and Excel

program experience preferred

• Basic knowledge and ability to apply GCPs, ICH and applicable regulatory guidelines

• Knowledge of procedures for monitoring clinical trials, GCP and medical terminology preferred,

but not mandatory

• Demonstrated good problem solving and organizational skills, able to handle and prioritize

multiple tasks

• Able to perform assigned task with minimal direct supervision by Line Manager or Clinical Lead

• Expanded knowledge of clinical research and operations, prior monitoring experience or

equivalent preferred, expected to expand knowledge base and be able to apply relevant GCP,

ICH and regulatory guidelines and procedures to assigned tasks

• Demonstrated good problem solving

• Able to handle and prioritize multiple tasks/assignments

• Demonstrated ability to work in a cross functional manner

• Effective oral and written communication skills with both individuals and groups. Good command

of English language required.

• Aptitude for training both in-house and site personnel

• Effective interpersonal and organizational skills

• Must possess a valid drivers license where applicable

Experience:

• RN/BSN, BS/MS or BA with 3-5 years related clinical research experience preferred or two-year

Associates degree plus 4-5 years experience in clinical monitoring. Alternatively, a high school

diploma or equivalent and 7 or more years of related experience in a scientific or healthcare field

may be considered (in lieu of an academic degree) OR equivalent combination of education,

training and experience

• At least 3 years clinical monitoring research experience, encompassing all the activities of a

Clinical Research Associate (all types of monitoring visits) and some prior clinical lead

experience

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.



Job ID: R1110140