clinical project manager

PCI Pharma Services

<div><div>Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.</div><div><br>
We are PCI.</div><div><br>
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.</div><div></div><div><br>
Supports assigned clinical customer projects to ensure that project goals and objectives are accomplished within the prescribed time frame, budget, and in accordance with customer expectations. Diligently manages significant matters pertaining to assigned projects to &ldquo;Provide the industry&rsquo;s leading customer experience&rdquo; supporting PCI Clinical Service&rsquo;s long term growth and success.</div><div></div><div>
ESSENTIAL DUTIES AND RESPONSIBILITIES:</div><div></div><ul><li>
Provide continuous support to Project Manager and team by being the daily point contact for day-to-day internal problem solving and trouble-shooting.</li><li>
Leads weekly customer calls and Clinical Project Team meetings in absence of Project Manager or as designated.</li><li>
Creates notes for weekly customer teleconference calls and internal Clinical Project Team meetings.</li><li>
Creates project specific documentation including packaging/labeling protocols, variable data forms, sample shipment request forms, monthly finished goods inventories, logistics instructions, returns accountability worksheet, monthly distribution reports.</li><li>
Manages timing of internal process to ensure timely receipt and release of bulk, project packaging components, and shipping supplies.</li><li>
Communicates with customers and vendors to resolve missing or erroneous certs and documentation related to receiving and QC release of bulk, packaging components, and shipping supplies.</li><li>
Monitors and updates Clinical Project Coordinator with production needs for project.</li><li>
Creates project specific bills of material.</li><li>
Works closely with internal groups and vendors to ensure project milestones are achieved, including labeling and component design and delivery and on-time shipments of order requests.</li><li>
Identifies lot specific drug product and components for production job staging.</li><li>
Works with customers and sites to resolve discrepancies on end of study returns.</li><li>
Creates Destruction Authorization Forms and forwards to customer for destruction approval of returns, remaining finished goods, and customer owned inventories.</li><li>
Assists in monthly packaging and distribution invoices processing.</li><li>
Records data in project specific metrics.</li><li>
Resolves shipment delivery issues by working closely with distribution group, carriers, customer, and clinical sites.</li><li>
Assumes the role of the client advocate and acts as secondary client communication point for clinical packaging, storage, and distribution for assigned projects. Acts as back-up Project Manager contact for internal communications and trouble-shooting.</li><li>
Accountable for assigned project tasks using appropriate project planning tools.</li><li>
Host and manage customer visits at PCI as necessary.</li><li>
Support cross-functional leadership on improvement opportunities and strategic initiatives.</li><li>
Participate in meetings and reporting with Project Management, Operations, and Quality management.</li><li>
Training and on-boarding of new employees within same role as requested.</li><li>
Maintains and updates project plans and timelines as requested.</li><li>
Knowledge of and adherence to all PCI, cGMP and cGCP policies, procedures, rules and regulations as applicable to assigned clinical projects.</li><li>
This position may require overtime and/or weekend work.</li><li>
Attendance to work is an essential function of this position.</li><li>
Performs job duties as assigned by Manager/Supervisor.</li></ul><div></div><div>
QUALIFICATIONS:</div><div></div><div>
Required:</div><ul><li>
Associate's Degree in a related field and/or 1-3 years related experience and/or training.</li><li>
Basic Mathematical Skills</li><li>
Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.</li><li>
Minimum Professional Proficiency: Ability to speak in a way that allows one to participate effectively in various conversations. Ability to read various types of standard items addressed to general readers.</li><li>
Intermediate Reasoning: Ability to apply common sense understanding to carry out instructions that may be furnished in written, oral, or diagram form. Ability to deal with problems that involve several concrete variables in standardized situations.</li></ul><div></div><div>
Preferred:</div><ul><li>
Ability to work independently and/or as part of a team.</li><li>
Ability to display excellent time management skills.</li><li>
Ability to display a willingness to make decisions.</li><li>
Ability to adapt to changing work environments.</li></ul><div></div><div>
The base salary hiring range for this position is ($56,720- $64,000) plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).</div><div></div><div>
The APM role begins 100% onsite for first 90 days. &quot;Upon successful completion of key milestone tasks, a review of remote flexibility will be discussed among APM, PM and Sr. Mgr to determine eligibility for a hybrid work model.&quot;</div><div></div><div>
Join us and be part of building the bridge between life changing therapies and patients. <div>Let&rsquo;s talk future</div></div><div></div><div>
Equal Employment Opportunity (EEO) Statement:<br>
<i>PCI Pharma Services is an Equal </i><i>Opportunity/Affirmative</i><i> Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.</i></div><div></div><div><i>
At PCI, Equity and Inclusion are at the core of our company&rsquo;s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity &ndash; at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.</i></div></div><div></div>

Clinical Associate Project Man

Syneos Health

<div><p><b>Description</b>
</p>Principal Tech Project Manager (must have: clinical experience, GxP)<p></p><p>
Syneos Health&reg; is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.</p><p>
Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life&reg;.</p><p></p><p>
Discover what our 29,000 employees, across 110 countries already know.</p><p></p><p><b>
WORK HERE MATTERS EVERYWHERE</b></p><p></p><p>
Why Syneos Health</p><ul><li>
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.</li><li>
We are committed to our Total Self culture &ndash; where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.</li><li>
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives &ndash; we&rsquo;re able to create a place where everyone feels like they belong.</li></ul><p></p><p><b>
Job Responsibilities</b></p><p></p><h3 class="jobSectionHeader"><b>
JOB RESPONSIBILITIES</b></h3><p></p><ul><li>
Oversee program execution to ensure adherence to budget, schedule, and scope. Drive large complex portfolio prioritization, planning, execution, actively managing risks and issues and communicating status in an objective manner to all stakeholders.</li><li>
Responsible for the overall planning, coordination, and execution of the program, managing interdependencies between projects, and optimizing resources across the program.</li><li>
Set program goals, define scope, track progress, and mitigate risks.</li><li>
Collaborate with stakeholders, project managers, and cross-functional teams to ensure that all projects within the program contribute effectively to the broader business strategy.</li><li>
Strong leadership, strategic thinking, and a deep understanding of Tech systems and business processes are essential for this role.</li><li>
Oversight of project managers for the planning and execution of a portfolio of varying complexity of product development.</li><li>
Sets and resets project/program/portfolio process procedures, timelines, and priorities with appropriate executive management approval.</li><li>
Establishes project procedures, rules, and guidelines; approves exceptions and modifications within own area of responsibility.</li><li>
Support Business Partner &amp; Product Manager in Benefits Management</li><li>
Manages relationships with technology vendors used for the different projects in the program including SOW/PO Management</li><li>
Analyzes the impact of changes in existing projects or addition of new projects and identifies strategies (resources allocation/project sequencing) for accomplishing all desired projects</li><li>
Build and maintaining strong relationships with stakeholders, understanding their needs, and addressing any concerns or issues that arise</li></ul><p><b>
QUALIFICATION REQUIREMENTS
</b></p><p></p><ul><li>Bachelor&rsquo;s Degree (BA/BS) in a technical discipline or relevant field</li><li>
Experience in program management, preferably in the healthcare or pharmaceutical industry</li><li>
Excellent communication and interpersonal skills, with the ability to effectively interact with clients, stakeholders, and team members</li><li>
Proven track record of successfully leading and delivering complex programs on time and within budget</li><li>
Extensive knowledge of project management tools and methodologies, experience using project management and business management computer software.</li><li>
Thorough understanding of budgeting, project management, and resource management</li><li>
Strong leadership skills with the ability to inspire and motivate teams to achieve excellence.</li></ul><p>
PMP certification or equivalent preferred</p><p></p><p><b>
Get to know Syneos Health</b></p><p></p><p>
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.</p><p></p><p>
No matter what your role is, you&rsquo;ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.</p><p><br>
http://www.syneoshealth.com</p><p></p><p><b>
Additional Information</b></p><p></p><p>
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.</p><p><b>
Summary</b>
</p>The Principal Project Manager is responsible for comprehensively developing and managing all components of the assigned portfolio of product development work which may include execution and management of critical cross-function and strategic initiatives for leadership. This role supports our business goals by serving as a liaison between business and technical aspects of programs to ensure delivery of intended outcomes.</div>

Principal Tech Project Manager (must have: clinical experience, GxP)

UChicago Medicine

<div>Job Description:
<div>
Be a part of a world-class academic healthcare system, <b>UChicago Medicine</b>, as a<b> Project Manager</b><b>.</b></div><div></div><div><br>
The <b>Project Manager</b> is responsible for the programmatic management, longitudinal support, and implementation of strategies for the overall improvement of outcome metrics as defined by external agencies with a primary focus on US News and World Report Best Hospital, Leapfrog, CMS Stars, and Vizient ratings.</div><div></div><div><br>
As the <b>Project Manager </b>you will prioritize initiatives and manage teams to drive achievement of short and long-term goals of the University of Chicago Medicine that represent our exceptional clinical programs. The PM is expected to work collaboratively with UChicago Medicine&rsquo;s quality, clinical, and service line leadership to lead, support, and participate in system-wide initiatives.</div><div></div><div><b><br>
Essential Job Functions:</b></div><ul><li>
Supports the operational and clinical improvement activities highlighted by external ratings/rankings as defined by leadership.</li><li>
In partnership with service line leadership, leads the evaluation/assessment, prioritization, planning, and implementation of targeted improvement efforts around external rating agencies</li><li>
Identify, coordinate, and manage several related projects to advance the strategic goals of external assessments.</li><li>
Measure the impact of the program and take accountability in partnership with the Director for meeting program goals.</li><li>
Provide regular updates to leadership on program progress, milestones, and barriers.</li><li>
Supports the development of external relationships with agencies.</li><li>
Execute the project plan and provides daily support for moving the project forward on large strategic initiatives. Collaborates and oversees the project management of projects within the program.
</li><li>Identifies and communicates alignment and impact of project plans on related projects across the organization.</li><li>
Proactively anticipates project risks and establishes contingency plans for project success.</li><li>
Oversees the planning, design, implementation, and completion of the project</li><li>
Develop and carry out the strategy for the facilitation of complex, multidisciplinary meetings.</li><li>
Facilitates decision-making to achieve consensus on plans and next steps with stakeholder buy-in.</li><li>
Expertly navigate relationships and problem solving during meetings with front-line staff, physician leadership, and hospital leadership
</li><li>Supports work groups and executive committees
</li><li>Collaborate with data teams within UCM to ensure data and analytics needs of assigned projects are satisfied and garner the most effective clinical monitors and insight to drive improvement while allowing for efficient analytics processes.</li><li>
Collaborate with data teams within UCM on measure development, analysis, and report generation processes.</li><li>
Utilize available benchmarking data and tools (e.g. Vizient, HDI, CMS) to identify and prioritize opportunities within external assessments.</li><li>
Monitors project KPIs throughout the external assessment cycles.</li></ul><p><b>
Required Qualifications:</b></p><ul><li>
Bachelor's Degree required in a healthcare-related field preferred</li><li>
3-5 years of experience within a healthcare setting preferred with project management and/or data analysis experience</li></ul><div><b>
Preferred</b></div><ul><li>
Master&rsquo;s degree in a healthcare-related field preferred</li></ul><p><b>
Position Details:</b></p><ul><li>
Job Type/FTE: Full Time (1.0 FTE)</li><li>
Shift: Days &ndash; 8-hour shift
</li><li>Unit/Department: Affiliated Services</li><li>
CBA Code: Non-Union</li></ul>
Why Join Us:
<div><i>
We&rsquo;ve been at the forefront of medicine since 1899. We provide superior healthcare with compassion, always mindful that each patient is a person, an individual. To accomplish this, we need employees with passion, talent and commitment&hellip; with patients and with each other. We&rsquo;re in this together: working to advance medical innovation, serve the health needs of the community, and move our collective knowledge forward. If you&rsquo;d like to add enriching human life to your profile, UChicago Medicine is for you. Here at the forefront, we&rsquo;re doing work that really matters. Join us. Bring your passion.</i></div><div></div><div><i><br>
UChicago Medicine is growing; discover how you can be a part of this pursuit of excellence at: </i><i>UChicago Medicine Career Opportunities</i></div><div></div><div><i><br>
UChicago Medicine is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, ethnicity, ancestry, sex, sexual orientation, gender identity, marital status, civil union status, parental status, religion, national origin, age, disability, veteran status and other legally protected characteristics.</i></div><div></div><div><i><br>
As a condition of employment, all employees are required to complete a pre-employment physical, background check, drug screening, and comply with the flu vaccination requirements prior to hire. Medical and religious exemptions will be considered for flu vaccination consistent with applicable law.</i></div><div></div><div><b><i><br>
Compensation &amp; Benefits Overview</i></b></div><div></div><div><i><br>
UChicago Medicine is committed to transparency in compensation and benefits. The pay range provided reflects the anticipated wage or salary reasonably expected to be offered for the position.</i></div><div></div><div><i><br>
The pay range is based on a full-time equivalent (1.0 FTE) and is reflective of current market data, reviewed on an annual basis. Compensation offered at the time of hire will vary based on candidate qualifications and experience and organizational considerations, such as internal equity. Pay ranges for employees subject to Collective Bargaining Agreements are negotiated by the medical center and their respective union.</i></div><div></div><div><i><br>
Review the full complement of benefit options for eligible roles at </i><i>Benefits - UChicago Medicine</i><i>.</i></div></div>

Project Manager

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

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

<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>

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>

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