clinical study lead

Roche

<div><p>Bei Roche kannst du ganz du selbst sein und wirst f&uuml;r deine einzigartigen Qualit&auml;ten gesch&auml;tzt. Unsere Kultur f&ouml;rdert pers&ouml;nlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du f&uuml;r das, was du bist, wertgesch&auml;tzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl pers&ouml;nlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat &ndash; heute und in Zukunft. Werde Teil von Roche, wo jede Stimme z&auml;hlt.</p><div></div><div>
Die Position</div><p>
The role focuses on the responsibilities to ensure leadership and execution of one or more sponsored interventional trials or managed primary data collection non-interventional studies, the effective and efficient delivery of all operational aspects in accordance with the appropriate quality standards including ICH/GCP and GVPs/GPPs.</p><p></p><p><b>
Your Responsibilities</b></p><ul><li><p>
Ensures study adherence to appropriate guidelines (ICH GCP/GVP/GPP), relevant regulations and Roche procedural documents. Ensures study inspection readiness at all times. Ensures the completion and finalization of any corrective and preventive action plans resulting from site audits and inspections</p></li><li><p>
Provides operational input and insights into the development of study protocols, Clinical Study Reports, informed consent form and protocol feasibility questionnaires</p></li><li><p>
Promotes operational excellence. Oversees the delivery and maintenance of essential study plans and systems (e.g. site &amp; country selection and monitoring plan; study tracking systems, clinical supply; vendor oversight plan; RBQM or equivalent risk management activities). Ensures accurate tracking and reporting of study metrics</p></li><li><p>
Chairs Study Management Team meetings and organizes the investigator meetings and study kick-off meetings</p></li><li><p>
Establishes and maintains study budgets and approves invoices, identifies and communicates any issues/variances with study budgets and action plans for resolution</p></li><li><p>
Accountable for all vendor related operational study deliverables, according to timelines, budget, operational procedures, quality/compliance and performance standards. Leads vendor selections by reviewing proposals and providing recommendations, reviews and negotiates clinical work orders. Maintains oversight of vendor performance, issues, and their resolution and identifies systematic issues and coordinates any corrective action. Ensures vendors receive appropriate training.</p></li><li><p>
Ensures proper handling of all study close out activities including but not limited to the site close out, final drug accountability, final safety reconciliation and Inspection readiness of Trial Master File documentation.</p></li></ul><p></p><p><b>
Who you are</b></p><ul><li><p>
Strong leadership skills developed through leading successful multi-functional matrix study teams through all stages of clinical studies.</p></li><li><p>
Proven strategic capabilities, organizational awareness and proactive planning with embedded contingencies and risk management mindset.</p></li><li><p>
Clear understanding and experience applying ICH/GCP and/or GVP/GPPs and applicable regulations including awareness of quality requirements.</p></li><li><p>
Well-developed written and verbal communication skills demonstrated by an ability to present clear instructions/directions, to motivate your team, negotiate with peers and partners and influence cross functionally.</p></li><li><p>
Excellent problem solving, negotiation and conflict resolution skills</p></li><li><p>
Borderless Collaboration: working closely with other countries/communities/teams, embracing the loop of &lsquo;sharing and learning together&rsquo; to co-create Solutions</p></li><li><p>
Budget Management- cost effective management with limited unforeseen cost overruns.</p></li></ul><p></p><div><br>
Wer wir sind</div><p>
Eine ges&uuml;ndere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat &ndash; heute und f&uuml;r zuk&uuml;nftige Generationen. Durch unser Engagement werden &uuml;ber 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgef&uuml;hrt. Wir ermutigen uns gegenseitig, neue M&ouml;glichkeiten zu erkunden, Kreativit&auml;t zu f&ouml;rdern und hohe Ziele zu setzen, um lebensver&auml;ndernde Gesundheitsl&ouml;sungen zu liefern.</p><p></p><p>
Gemeinsam k&ouml;nnen wir eine ges&uuml;ndere Zukunft gestalten.</p><p></p><p><b>
Roche ist ein Arbeitgeber, der die Chancengleichheit f&ouml;rdert.</b></p></div>

Clinical Study Lead

IQVIA

<div><div><div>Riyadh, Saudi Arabia | Full time | Hybrid | R1521758</div></div><p></p><div><div><br>
Job Overview</div><div><br>
Perform a variety of clinical procedures to collect, record, report and interpret data on patients enrolled and/or seeking enrollment in clinical studies according to the protocol, standard operating procedures (SOPs), and Good Clinical Practice (GCP). Assist with daily workload planning.<br>
<br>
Essential Functions</div><div><ul><li><br>
Provide clinical research support to investigators to prepare for and execute assigned research studies, including:</li><li>Review study protocols, Case Report Forms (CRFs), other study-specific documents, and electronic data capture systems used to record clinical research data</li><li>Attend all relevant study meetings</li><li>Collect and submit regulatory/ethics documentation as required by the FDA and other regulatory bodies governing the conduct of clinical research</li><li>Recruit and screen patients for clinical trials and maintain subject screening logs</li><li>Orient research subjects to the study, including the purpose of the study, procedures, and protocol issues such as timelines for visits</li><li>Design and maintain source documentation based on protocol requirements</li><li>Schedule and execute study visits and perform study procedures</li><li>Collect, record and maintain research subject study data according to study protocol and SOPs, preserving quality control for content, accuracy and completeness</li><li>Handle lab testing and analysis, including preparation of specimen collection tubes and lab logistics</li><li>Monitor subject safety and report adverse reactions to appropriate medical personnel</li><li>Correspond with research subjects and troubleshoot study-related questions or issues</li><li>Participate in &ldquo;huddles&rdquo; to confirm daily study tasks are assigned to team members and are executed to the expected standards</li><li>Assist with study data quality checking and query resolution.</li><li>Perform a variety of complex clinical research procedures including but not limited to ECG, sample collection, spirometry, vital signs, dose verification, cannulation and cardiac telemetry monitoring.</li><li>Record, report and interpret study findings appropriately to develop a study-specific database.</li><li>Assist investigator in verifying that research study objectives are met on time, within budget and according to applicable protocol requirements, clinical research regulations and quality standards.</li><li>Provide training to new investigator site staff members on study-specific topics and requirements. Assist in maintaining adherence to investigator site staff training requirements by auditing and maintaining training records.</li><li>Prepare for and attend study monitoring visits, study audits, and regulatory inspections with clinical research regulatory agencies.</li><li>Assist research site with coverage planning related to staffing and scheduling for research projects.</li></ul><br>
Qualifications</div><div><ul><li><br>
Bachelor's Degree</li><li>3 years&rsquo; relevant work experience in a clinical environment or medical setting, e.g., medical assistant, assistant nurse, laboratory technician; or equivalent combination of education, training and experience</li></ul></div><ul><li>Working knowledge of clinical trials</li><li>Working knowledge of the principles of Good Clinical Practices (GCP)</li><li>In-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedules</li><li>Skill in carrying out required clinical procedures such as intravenous catheter insertion and spirometry testing</li><li>Good skill in using MS Windows and Office applications such as Access, Outlook and Word</li><li>Excellent interpersonal skills</li><li>Ability to pay close attention to detail</li><li>Ability to establish and maintain effective working relationships with coworkers, managers and clients</li><li>Applicable certifications and licenses as required by company, country, state, and/or other regulatory bodies</li></ul><div>
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</div></div></div><div></div>

Site Coordinator

<div><p><b>Job Overview</b><br>
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.</p><p></p><div><b>
Essential Functions</b><br>
<ul><li>Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.</li><li>Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.</li><li>Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.</li><li>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.</li><li>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.</li><li>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 and local regulatory requirements.</li><li>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.</li><li>Collaborate and liaise with study team members for project execution support as appropriate.</li><li>If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.</li><li>If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.</li></ul></div><p></p><div><b>
Qualifications</b><br>
<ul><li>High School Diploma or equivalent Degree in scientific discipline or health care preferred.</li><li>Requires at least 2 years of year of on-site monitoring experience.</li><li>Equivalent combination of education, training and experience may be accepted in lieu of degree.</li><li>Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.</li><li>i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.</li><li>Good therapeutic and protocol knowledge as provided in company training.</li><li>Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).</li><li>Written and verbal communication skills including good command of Arabic and English language.</li><li>Organizational and problem-solving skills.</li><li>Effective time and financial management skills.</li><li>Ability to establish and maintain effective working relationships with coworkers, managers, and clients.</li></ul></div><p></p><p>
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</p></div>

Experienced Clinical Research Associate Sponsor-dedicated

Ray-CRO

<p>Clinical Research Associate (CRA) Opportunity &ndash; Saudi Arabia</p><p>RAY-CRO is expanding its operations in Saudi Arabia and is seeking a qualified Clinical Research Associate (CRA) to support regional clinical research activities and contribute to high-quality study execution.</p><p>The successful candidate will be responsible for:</p><ul><li>End-to-end site management from initiation through close-out</li><li>Ensuring compliance with ICH-GCP, study protocols, and applicable regulatory requirements</li><li>Effective communication with investigative sites, sponsors, and internal teams</li><li>Proactive issue identification and resolution</li><li>Maintaining high standards of quality, timelines, and patient safety</li></ul><p>Location: KSA<br/>Applications: careers@ray-cro.com</p><p>This is an excellent opportunity to join a regional CRO with an expanding clinical research footprint in Saudi Arabia.</p><p>Job Type: Full-time</p><p>Work Location: In person</p>

Clinical Research Associate

Novartis

<div>
 <strong>
  Summary
  <br/>
  <br/>
 </strong>
 To serve as a liaison to the medical/ scientific community and responsible for establishing, developing and partnering with Health Care Providers/ Professionals (HCPs), e.g. external Medical Experts, study investigators, treatment guideline experts, etc. to ensure the appropriate dissemination of clinical and scientific information regarding Novartis&rsquo; compounds in a timely, ethical and stakeholder-focused manner. To implement clinical and educational strategies in collaboration with other Novartis colleagues for designated stakeholders. To pair key stakeholders&rsquo; scientific educational and research needs with available Novartis resources and provide the latest emerging data in response to specific HCP inquiries, as appropriate.
 <br/>
 <br/>
 <strong>
  About The Role
  <br/>
  <br/>
 </strong>
 <strong>
  Medical Expert Engagement
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Identify, map, and engage Medical Experts and study investigators in alignment with the Integrated Product Strategy (IPS).
  </li>
  <li>
   Share medical, scientific, and health outcomes evidence on Novartis compounds, therapeutic areas, and new treatment options with HCPs and key stakeholders.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Scientific Information &amp; Requests
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Respond to unsolicited HCP requests by presenting globally approved data, including compounds in development.
  </li>
  <li>
   Involve HCPs in advisory boards, educational activities, and publications when relevant.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Clinical Research Support
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Educate on Novartis clinical research programs, recommend study sites, and support trial feasibility and accrual.
  </li>
  <li>
   Facilitate IIT submissions and material transfer agreements for independent research.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Scientific Exchange &amp; Insights
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Promote scientific exchange on emerging principles and trends.
  </li>
  <li>
   Collect and report HCP insights to inform medical strategy and IPS planning.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Internal Contributions
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Act as a local medical resource for disease area and product training.
  </li>
  <li>
   Contribute to IPS and Medical Affairs strategy design and execution.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Compliance &amp; Integrity
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Ensure adherence to all compliance processes (e.g., IIT, Medical Affairs Field Interactions).
  </li>
  <li>
   Foster a diverse, inclusive, and harassment-free environment.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Education &amp; Communication
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Provide scientific and educational information to HCPs on patient-critical issues.
  </li>
  <li>
   Support internal capability building through training and knowledge sharing.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Minimum Requirements
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   A degree in PharmD, PhD, MD (Medical Doctor) is essential.
  </li>
  <li>
   At least 1-year experience as Medical Science Liaison, specific experience in Cardiovascular or Oncology is a plus.
  </li>
  <li>
   Fluent in both Arabic and English languages.
  </li>
  <li>
   Willing to be based in Riyadh.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Why Novartis:
 </strong>
 Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients&rsquo; lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
 <br/>
 <br/>
 <strong>
  Benefits and Rewards:
 </strong>
 Read our handbook to learn about all the ways we&rsquo;ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
 <br/>
 <br/>
</div>


Medical Science Liaison - Riyadh

<div>
 <strong>
  Summary
  <br/>
  <br/>
 </strong>
 The primary responsibility of this role is to plan, develop, design and execute Real World Evidence (RWE) studies in Saudi Arabia to develop and demonstrate the value of Novartis marketed and pipeline products to payers and clinicians across different therapeutic areas.
 <br/>
 <br/>
 <strong>
  About The Role
  <br/>
  <br/>
 </strong>
 <strong>
  Major Accountabilities:
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Design and implement innovative Real-World Evidence (RWE) programs to address drug development challenges, support regulatory decisions (e.g., label changes, new indications), and enable payer decision-making for reimbursement success.
  </li>
  <li>
   Lead implementation research initiatives, including population health models, to drive adoption of Novartis innovations aligned with patient and healthcare system needs.
  </li>
  <li>
   Map and license Real World Data (RWD) sources, build research collaborations, and execute RWE projects in close partnership with cross-functional teams.
  </li>
  <li>
   Develop and integrate RWE strategies into product/disease area plans and launch strategies, ensuring alignment with global and local evidence plans.
  </li>
  <li>
   Support integrated evidence planning, cost-effectiveness modeling, and external HEOR partnerships to strengthen access and reimbursement efforts.
  </li>
  <li>
   Manage collaborations with investigators, KOLs, vendors, and external stakeholders to co-design innovative study designs and ensure quality delivery of research projects.
  </li>
  <li>
   Communicate scientifically valid RWE to stakeholders (HCPs, payers, regulators) and lead internal training on advanced RWE methodologies and implementation science.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Minimum Requirements
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   A degree as Medical Doctor (MD) or PharmD or PhD. Also, if they have a master's degree in health science and/or master's in Evidence Generations / Clinical Research.
  </li>
  <li>
   Languages: Fluent in English (oral and written), Arabic (native) is preferable.
  </li>
  <li>
   Minimum 3+ years of experience in conducting RWE research for pharmaceutical products within pharma, CROs, or academic institutions; or in a closely related discipline (e.g., clinical research, statistics, epidemiology, pricing).
  </li>
  <li>
   Strong understanding of Medical Affairs, Drug Development, Market Access/HEOR, Safety, or related areas to generate value evidence from both retrospective and prospective studies.
  </li>
  <li>
   Good Understanding of Saudi Arabia market research landscape.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Why Novartis:
 </strong>
 Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients&rsquo; lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
 <br/>
 <br/>
 <strong>
  Benefits and Rewards:
 </strong>
 Read our handbook to learn about all the ways we&rsquo;ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
 <br/>
 <br/>
</div>


Evidence Generation Head

<div><div><h3 class="jobSectionHeader"><b>Summary
</b></h3><div>The primary responsibility of this role is to plan, develop, design and execute Real World Evidence (RWE) studies in Saudi Arabia to develop and demonstrate the value of Novartis marketed and pipeline products to payers and clinicians across different therapeutic areas.<br>
<br>
#LI-Onsite</div>
</div><div><h3 class="jobSectionHeader"><b>About the Role
</b></h3><div><p><b>Major Accountabilities:</b></p><div><ul><li>
Design and implement innovative Real-World Evidence (RWE) programs to address drug development challenges, support regulatory decisions (e.g., label changes, new indications), and enable payer decision-making for reimbursement success.</li><li>
Lead implementation research initiatives, including population health models, to drive adoption of Novartis innovations aligned with patient and healthcare system needs.</li><li>
Map and license Real World Data (RWD) sources, build research collaborations, and execute RWE projects in close partnership with cross-functional teams.</li><li>
Develop and integrate RWE strategies into product/disease area plans and launch strategies, ensuring alignment with global and local evidence plans.</li><li>
Support integrated evidence planning, cost-effectiveness modeling, and external HEOR partnerships to strengthen access and reimbursement efforts.</li><li>
Manage collaborations with investigators, KOLs, vendors, and external stakeholders to co-design innovative study designs and ensure quality delivery of research projects.</li><li>
Communicate scientifically valid RWE to stakeholders (HCPs, payers, regulators) and lead internal training on advanced RWE methodologies and implementation science.</li></ul></div><p><b>
Minimum Requirements
</b></p><ul><li><b>A degree as </b>Medical Doctor (MD) or PharmD or PhD. Also, if they have a master's degree in health science and/or master's in Evidence Generations / Clinical Research.</li><li><b>
Languages: </b>Fluent in English (oral and written), Arabic (native) is preferable.</li><li>
Minimum <b>3+ years of experience</b> in conducting RWE research for pharmaceutical products within pharma, CROs, or academic institutions; or in a closely related discipline (e.g., clinical research, statistics, epidemiology, pricing).</li><li>
Strong understanding of <b>Medical Affairs</b>, <b>Drug Development</b>, <b>Market Access/HEOR</b>, <b>Safety</b>, or related areas to generate value evidence from both retrospective and prospective studies.</li><li>
Good Understanding of <b>Saudi Arabia market research landscape</b>.</li></ul></div><p></p>
</div><div><div><p><b>Why Novartis:</b> Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients&rsquo; lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture</p><p><b>
Benefits and Rewards:</b> Read our handbook to learn about all the ways we&rsquo;ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards</p></div></div></div>
<br><div><div>Division
<div>International
</div></div><div>Business Unit
<div>Development
</div></div><div>Location
<div>Saudi Arabia
</div></div><div>Site
<div>Riyadh
</div></div><div>Company / Legal Entity
<div>SA01 (FCRS = SA001) Novartis Saudi Arabia Ltd
</div></div><div>Functional Area
<div>Research &amp; Development
</div></div><div>Job Type
<div>Full time
</div></div><div>Employment Type
<div>Regular
</div></div><div>Shift Work
<div>No
</div></div><div></div><div><p>Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.</p></div></div>

Explore 715+ Clinical study lead in Riyadh Saudi Arabia this January. Find roles across top companies and apply now to boost your career.

715 clinical study lead jobs IN Riyadh Saudi Arabia

Clinical Study Lead

Site Coordinator

Experienced Clinical Research Associate Sponsor-dedicated

Clinical Research Associate

Medical Science Liaison - Riyadh

Evidence Generation Head

Evidence Generation Head