clinical study manager

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

City of Hope

<div><div><div><div><div><div><div><div><div><b>Clinical Study Coordinator - Clinical Research (On-Site-Duarte,CA)</b></div><div>
Join the transformative team at City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. City of Hope&rsquo;s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and treatment facilities in Atlanta, Chicago and Phoenix. Our dedicated and compassionate employees are driven by a common mission: To deliver the cures of tomorrow to the people who need them today.</div><div>
Duarte Medical Center seeks a full-time, on-site Clinical Study Coordinator to support oncology clinical trials. Under the supervision of the Director, Clinical Research, this patient-facing role involves coordinating First in Human to Phase III and Investigator-Initiated Trials. Responsibilities include patient recruitment, informed consent, trial coordination, data management, and regulatory compliance. The position requires in-depth knowledge of clinical trial regulations, strong organizational skills, and the ability to collaborate with investigators and clinical staff in a fast-paced environment.</div><div><b>
As a successful candidate, you will:</b></div><ul><li>
Understand and apply federal regulations (FDA, OHRP, GCP/ICH, HIPAA) and institutional policies.</li><li>
Follow and execute clinical trial protocols and procedures.</li><li>
Coordinate participant recruitment, informed consent, and care.</li><li>
Communicate with participants, investigators, and sponsors to ensure clear understanding and compliance.</li><li>
Monitor and document participant eligibility, safety, and protocol adherence, and report adverse events promptly.</li><li>
Pursue continuous education and training opportunities, staying updated with the latest clinical research information, and maintain necessary certifications and licensure.</li></ul></div></div></div></div></div></div></div><div></div><div><div><div><b>
Your qualifications should include:</b></div><ul><li>
Bachelor&rsquo;s degree in Science, Health or related field from an accredited university; 3 additional years of experience plus the minimum experience requirement may substitute for minimum education.</li><li>
Minimum of 2 years research or relevant clinical experience</li><li>
ACRP or SOCRA certification within 1 year of employment</li><li>
International Air Transport Association (IATA) within 1 month of employment</li><li>
Good Clinical Practice (GCP) within 1 month of employment</li><li>
Human Subjects Protection (HSP) within 1 month of employment</li><li>
Basic Life Support (BLS) within 1 month of employment</li></ul><div><b>
City of Hope is an equal opportunity employer. To learn more about our commitment to diversity, equity, and inclusion, please </b><b>click here</b><b>.</b></div><div><b>
To learn more about our Comprehensive Benefits, please </b><b>CLICK HERE</b><b>.</b></div></div></div></div>

Clinical Study Coordinator

ICON plc

<div>Manager Clinical Operations<div></div><div>
ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development</div><div></div><div>
We are currently seeking a Manager, Clinical Operations to join our diverse and dynamic team. As a Manager, Clinical Operations at ICON, you will play a pivotal role in overseeing the execution of clinical trials, ensuring that they are conducted efficiently, on time, and in compliance with regulatory requirements. You will contribute to the advancement of innovative therapies through strategic leadership in operational planning and management of clinical study teams.</div><div>
What You Will Be Doing:</div><div></div><ul><li>
Leading the operational planning and execution of clinical trials, ensuring adherence to protocols and timelines.</li><li>
Engaging with cross-functional teams to optimize trial design and enhance operational efficiency throughout the clinical development process.</li><li>
Monitoring trial progress and performance metrics, providing insights to inform decision-making and drive continuous improvement.</li><li>
Mentoring and developing junior staff, fostering a culture of collaboration and excellence within the team.</li><li>
Building strong relationships with internal and external stakeholders to facilitate smooth communication across clinical operations.</li></ul><div>
Your Profile:</div><div></div><ul><li>
Advanced degree in a relevant field such as life sciences, nursing, or a related discipline.</li><li>
Extensive experience in managing clinical operations, with a solid understanding of regulatory requirements and industry standards.</li><li>
Strong leadership skills with the ability to motivate and manage teams effectively in a dynamic environment.</li><li>
Proficiency in project management tools and methodologies, with a keen focus on optimizing processes.</li><li>
Excellent communication and interpersonal skills, with a proven ability to influence stakeholders and drive successful outcomes.</li><li>
Hybrid position (3 days per week in the office)</li></ul><div></div><div>
What ICON can offer you:</div><div></div><div><div><div><div><div>
Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.</div><div></div><div>
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.</div><div></div><div>
Our benefits examples include:</div><ul><li><div>
Various annual leave entitlements</div></li><li><div>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</div></li><li><div>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</div></li><li><div>
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family&rsquo;s well-being.</div></li><li><div>
Life assurance</div></li><li><div>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</div></li></ul></div></div></div></div><div></div><div>
Visit our <div>careers site</div> to read more about the benefits ICON offers.</div><div></div><div>
At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.</div><div></div><div><div><div><div><div>
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know</div><div></div><div><div>
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.</div></div></div></div></div></div></div><div></div>

Manager, Clinical Operations

IQVIA

<div><div><div>Malvern, United States of America | Full time | Home-based | R1520965</div><div><div><b>
Job available in additional locations</b></div></div></div><p></p><div><div><i><br>
IQVIA Biotech partners exclusively with biotech and emerging biopharma companies to support clinical development across all phases and therapeutic areas. agile structure, collaborative culture, and deep therapeutic expertise allow us to deliver tailored solutions that help bring innovative treatments to patients faster.</i></div><div>
Job Overview<br>
Associate Clinical Leads are an integral part of clinical trial delivery, working alongside clinical teams to improve patients&rsquo; lives by bringing new drugs to the market faster. The Associate Clinical Lead is a member of the core project team responsible for clinical delivery of clinical studies to meet contractual requirements in accordance with Standard Operating Procedures (SOPs), policies and practices. Associate Clinical Leads partner with Project Leaders and other functional teams to secure delivery requirements are met at all times.<br>
<br>
Essential Functions<br>
<ul><li>Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans).</li><li>Accountable for meeting projects&rsquo; recruitment targets and ensuring appropriate recruitment strategies are in place.</li><li>Contribute to the development of the project risk mitigation plan and manage clinical risks throughout the project&rsquo;s lifecycle.</li><li>Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues.</li><li>Manage clinical aspects of Project Finances including Estimate at Completion (EAC). Understand the scope of clinical delivery and create plans to deliver. Monitor and manage changes against baseline Estimate at Completion (EAC) and identify additional service opportunities or out of scope work.</li><li>Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management.</li><li>Collaborate with the clinical team to support milestone achievements. Report to internal and external stakeholders as per project scope requirements.</li><li>Resourcing and Talent Planning of the clinical team. Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance and project related trainings.</li><li>Conduct regular team meetings and communicate appropriately to achieve objectives.</li><li>Support professional development by providing feedback to clinical team line managers on performance relative to project tasks.</li><li>May work as the sole Clinical Lead on projects with 1-2 service lines and single/few countries or alongside more senior Clinical Leads to deliver large, global trials.;</li><li>May attend site visits as applicable in support of project delivery.</li></ul><br>
Qualifications<br>
<ul><li>Bachelor's Degree Bachelor's Degree in health care or other scientific discipline required</li><li>Requires 3 years clinical research/monitoring experience or equivalent combination of education, training and experience.;</li><li>Requires good knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.;</li><li>Requires broad protocol knowledge and therapeutic knowledge.;</li><li>Requires good understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates.</li><li>Requires basic understanding of project finances.;</li><li>Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e., International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct.;</li><li>Communication - Strong written and verbal communication skills including good command of English language.</li><li>Problem solving - Problem solving skills.</li><li>Organization - Planning, time management and prioritization skills.</li><li>Prioritization - Ability to handle conflicting priorities.</li><li>Quality - Attention to detail and accuracy in work.</li><li>Results-oriented approach to work delivery and output.; and PowerPoint.;</li><li>IT skills - Good software and computer skills, including Microsoft Office applications including but not limited to Microsoft Word, Excel and PowerPoint.;</li><li>Collaboration - Ability to establish and maintain effective working relationships with coworkers, managers and clients.</li><li>Cross-collaboration - Ability to work across cultures and geographies with a high awareness and understanding of cultural differences.</li><li>Effective communication - Ability to influence without authority.</li><li>IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, innovation, Ownership).</li></ul></div><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>
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe</div>
The potential base pay range for this role, when annualized, is $68,400.00 - $171,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.</div></div><div></div>

Clinical Trial Manager I, IQVIA Biotech

Ray-CRO

<p>Calling Clinical Project Leaders &ndash; KSA</p><p>At RAY-CRO, we don&rsquo;t just execute studies &mdash;<br/>we lead them, own them, and deliver real impact.</p><p>As we expand our regional clinical operations, we are looking for an experienced Clinical Project Leader (CPL) who can:</p><p>Take full ownership of clinical studies from start to finish<br/>Serve as the primary point of contact for sponsors and key stakeholders<br/>Lead CRAs and cross-functional teams with confidence and clarity<br/>Drive timelines, quality, and compliance across KSA<br/>✔Proactively manage risks, decisions, and escalations with accountability</p><p>If you are someone who:<br/>Thinks beyond tasks and focuses on outcomes<br/>Thrives in sponsor-facing roles and high-responsibility environments<br/>Brings solid CRO or pharma clinical project experience</p><p>This role is made for you.</p><p>Location: KSA</p><p>Apply: careers@ray-cro.com</p><p>Job Type: Full-time</p><p>Work Location: In person</p>

Clinical Project Leader

<p>Calling Clinical Project Leaders &ndash; Egypt</p><p>At RAY-CRO, we don&rsquo;t just execute studies &mdash;<br/>we lead them, own them, and deliver real impact.</p><p>As we expand our regional clinical operations, we are looking for an experienced Clinical Project Leader (CPL) who can:</p><p>Take full ownership of clinical studies from start to finish<br/>Serve as the primary point of contact for sponsors and key stakeholders<br/>Lead CRAs and cross-functional teams with confidence and clarity<br/>Drive timelines, quality, and compliance across Egypt &amp; KSA<br/>Proactively manage risks, decisions, and escalations with accountability</p><p>If you are someone who:<br/>Thinks beyond tasks and focuses on outcomes<br/>Thrives in sponsor-facing roles and high-responsibility environments<br/>Brings solid CRO or pharma clinical project experience</p><p>This role is made for you.</p><p>Location: Egypt<br/>Apply: careers@ray-cro.com</p><p>Job Type: Full-time</p>

Clinical Project Lead

<div><div><div>Springfield, United States of America | Full time | Home-based | R1520965</div><div><div><b>
Job available in additional locations</b></div></div></div><p></p><div><div><i><br>
IQVIA Biotech partners exclusively with biotech and emerging biopharma companies to support clinical development across all phases and therapeutic areas. agile structure, collaborative culture, and deep therapeutic expertise allow us to deliver tailored solutions that help bring innovative treatments to patients faster.</i></div><div>
Job Overview<br>
Associate Clinical Leads are an integral part of clinical trial delivery, working alongside clinical teams to improve patients&rsquo; lives by bringing new drugs to the market faster. The Associate Clinical Lead is a member of the core project team responsible for clinical delivery of clinical studies to meet contractual requirements in accordance with Standard Operating Procedures (SOPs), policies and practices. Associate Clinical Leads partner with Project Leaders and other functional teams to secure delivery requirements are met at all times.<br>
<br>
Essential Functions<br>
<ul><li>Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans).</li><li>Accountable for meeting projects&rsquo; recruitment targets and ensuring appropriate recruitment strategies are in place.</li><li>Contribute to the development of the project risk mitigation plan and manage clinical risks throughout the project&rsquo;s lifecycle.</li><li>Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues.</li><li>Manage clinical aspects of Project Finances including Estimate at Completion (EAC). Understand the scope of clinical delivery and create plans to deliver. Monitor and manage changes against baseline Estimate at Completion (EAC) and identify additional service opportunities or out of scope work.</li><li>Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management.</li><li>Collaborate with the clinical team to support milestone achievements. Report to internal and external stakeholders as per project scope requirements.</li><li>Resourcing and Talent Planning of the clinical team. Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance and project related trainings.</li><li>Conduct regular team meetings and communicate appropriately to achieve objectives.</li><li>Support professional development by providing feedback to clinical team line managers on performance relative to project tasks.</li><li>May work as the sole Clinical Lead on projects with 1-2 service lines and single/few countries or alongside more senior Clinical Leads to deliver large, global trials.;</li><li>May attend site visits as applicable in support of project delivery.</li></ul><br>
Qualifications<br>
<ul><li>Bachelor's Degree Bachelor's Degree in health care or other scientific discipline required</li><li>Requires 3 years clinical research/monitoring experience or equivalent combination of education, training and experience.;</li><li>Requires good knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.;</li><li>Requires broad protocol knowledge and therapeutic knowledge.;</li><li>Requires good understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates.</li><li>Requires basic understanding of project finances.;</li><li>Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e., International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct.;</li><li>Communication - Strong written and verbal communication skills including good command of English language.</li><li>Problem solving - Problem solving skills.</li><li>Organization - Planning, time management and prioritization skills.</li><li>Prioritization - Ability to handle conflicting priorities.</li><li>Quality - Attention to detail and accuracy in work.</li><li>Results-oriented approach to work delivery and output.; and PowerPoint.;</li><li>IT skills - Good software and computer skills, including Microsoft Office applications including but not limited to Microsoft Word, Excel and PowerPoint.;</li><li>Collaboration - Ability to establish and maintain effective working relationships with coworkers, managers and clients.</li><li>Cross-collaboration - Ability to work across cultures and geographies with a high awareness and understanding of cultural differences.</li><li>Effective communication - Ability to influence without authority.</li><li>IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, innovation, Ownership).</li></ul></div><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>
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe</div>
The potential base pay range for this role, when annualized, is $68,400.00 - $171,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.</div></div><div></div>

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