Clinical Project Manager

IQVIA; Riyadh; On-site; SAR 260,000 - 420,000; Full time

Job summary

IQVIA is seeking a Local Clinical Project Manager in Riyadh to lead country-level study teams and deliver clinical trial components on time and within budget, while complying with ICH-GCP and local regulations.

The role may include site monitoring, site qualification, regulatory submissions, budget management, CTMS setup, and ensuring essential documents are filed and archived. Fluency in Arabic and English and willingness to travel are required.

Qualifications

• Bachelor degree in life sciences or related discipline.
• At least 1 year of Local Clinical Project Management experience.
• Strong knowledge of Respiratory, Cardiovascular, Renal and Metabolic areas.
• Proven ability to lead cross-functional teams to deliver trials on time and budget.
• Solid understanding of the Clinical Study Process including monitoring.
• Excellent project management skills.
• Strong prioritization, multitasking, attention to detail and negotiation skills.
• Excellent spoken and written Arabic and English.
• Willingness to travel nationally and internationally.

Responsibilities

• Lead Local Study Team of CRA/CSA for assigned studies.
• Ensure delivery of study commitments with quality and timelines.
• Coordinate site selection, Site Quality Risk Assessment and Site Qualification Visits.
• Ensure timely regulatory submissions and cooperation with Regulatory Affairs.
• Prepare and manage country budgets and Master CSA.
• Maintain trial documentation per ICH-GCP and local regulations.
• Set up CTMS and local websites as required by local laws.
• Oversee monitoring activities from activation to study closure.
• Identify risks and coordinate issue resolution.

Skills

Leadership

Project management

Cross-functional collaboration

Attention to detail

Negotiation

Arabic language

English language

Clinical study process

Regulatory knowledge

Willingness to travel

Education

Bachelor degree in life sciences or related discipline

Job description

Riyadh, Saudi Arabia

Full time

R1573257

The Local Clinical Project Manager (Sponsor dedicated) will be leading Local Study Teams at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Sponsor Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.

In addition to leading the Local Study Teams, the Local Clinical Project Manager may perform site monitoring as needed to support the flexible capacity model. The Local Clinical Project Manager is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.

Main Responsibilities

Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.

Leads Local Study Team consisting of CRA(s), CSA(s), for assigned studies.

Leads the performance of the Local Study Team at country level ensuring compliance with Sponsor Procedural Documents, ICH-GCP and local regulations.

Ensures that clinical and operational feasibility assessment of potential studies is performed to the highest quality.

Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.

Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.

Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in Sponsor clinical studies financial system.

Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.

Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, including any relevant translations.

Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected.

Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction).

Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.

Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.

Reviews monitoring visit reports (as required and following Sponsor SOPs) and pro-actively advices the monitor(s) on study related matters.

Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.

Proactively identifies risks and facilitates resolution of complex study problems and issues.

Organises regular Local Study Team meetings on an agenda driven basis.

Required Skills and Qualifications

Bachelor degree in related discipline, preferably in life science, or equivalent qualification.

At least a year of experience in Clinical Project Management at Local level.

Very good knowledge of Respiratory or Cardiovascular, Renal and Metabolic therapeutic areas.

Proven ability to lead and motivate cross functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.

Excellent understanding of the Clinical Study Process including monitoring.

Excellent project management skills.

Strong ability to prioritize and handle multiple tasks, attention to details and negotiation skills.

Very good knowledge of spoken and written Arabic and English language.

Good ability to learn and to adapt to work with IT systems.

Ability to travel nationally and internationally as required.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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