clinical trials manager

Cancer Specialists of North Florida

<div><div><div><div><div><div><p><b><i>Cancer Specialists of North Florida</i></b> is recruiting for an experienced<b><i> Clinical Research Manager </i></b>for our busy practice. The Research Clinical Manager is responsible for the coordination of all research activities throughout the organization. This position is responsible for managing the administration of clinical trials and the clinical trial monitoring process. Duties include oversight of patients for clinical trials, presenting trial concepts and details to patients, providing education for staff and patients, and ensuring proper treatment for and assuming responsibility for clinical documentation for patients on protocol. In addition to this, the Manager acts to provide guidance and oversight for the research department and to ensure proper execution of clinical trials by all research employees. Essential duties and responsibilities include the following:</p><ul><li>
Obtain and review trials for participation upon research committee&rsquo;s approval; initiates study protocol by oversight of required regulatory documents submission.</li><li>
Responsible for oversight of research business operations including; departmental budgets, financial planning and tracking infrastructures, as well as protocol specific budgetary and contractual negotiations with pharmaceutical companies.</li><li>
Coordinates payment of provided study procedures and ensures accurate data collection in a timely manner to the sponsor.</li><li>
Maintains protocol regulatory documents for compliance with Institutional Review Board, including renewal, amendments and submissions of new protocols.</li><li>
Oversees clinical operations for research department including drug accountability, storage &amp; handling and proper mixing procedures.</li><li>
Maintains a sound plan for organization and recommends changes as needed due to growth and development of the research department.</li><li>
Holds and coordinates training for research personnel for a maximum service to patients in accordance with policies and procedures.</li><li>
Acts as a resource for clinical staff and patients regarding questions of protocol studies.</li><li>
Reports protocol activities, monthly accrual reports at meetings.</li><li>
Promotes and educate clinical staff on the protocol studies available to patient enrollment</li><li>
Develops and establishment of policies and procedures. Ensures their adequate execution, compliance and updates.</li><li>
Ensures all research activities are carried out in compliance with organizational policies, procedures, and governmental laws and regulations.</li><li>
Maintains strict patient confidentiality at all times.</li><li>
Special projects as assigned.</li></ul><p>
Full Time Position, Monday - Friday</p><p><b>
Location Address:</b> 7751 Belfort Parkway, Jacksonville, FL 32256</p><p><b>
Education and Experience:</b></p><ul><li>
Graduated from a four year accredited program.</li><li>
Minimum of seven years of oncology experience with chemotherapy and research experience</li><li>
Minimum of two years of management experience</li></ul><p><b>
Certificates, Licenses, Registrations:</b></p><ul><li>
Current licensure as a registered nurse or pharmacist in state of practice preferred</li><li>
Current BLCS certification required</li><li>
SOCRA or ACRP certification preferred</li></ul><p><b>
Compensation and Benefits:</b></p><ul><li>
Salary is commensurate with experience and qualifications</li></ul><p>
Cancer Specialists of North Florida is an &quot;EEO Employer&rdquo; and &ldquo;Drug Free Workplace&rdquo;</p></div></div></div></div></div></div>

Clinical Research Manager

Atrium Health

<p></p><div><p><b>Department:</b></p>
85296 Wake Forest University Health Sciences - Clinical Trial Methods Center of Excellence<p></p><p><b><br>
Status:</b>
</p>Full time<p></p><p><b><br>
Benefits Eligible:</b></p>
Yes<p></p><p><b><br>
Hou</b><b>rs Per Week:</b></p>
40<p></p><p><b><br>
Schedule Details/Additional Information:</b></p><p>
Regular</p><p></p><p><b>
Pay Range</b></p>
$43.30 - $64.95<p></p><p><b>
JOB SUMMARY</b></p><p></p><p>
The National Center for Clinical Trials (NCCT) is designed to serve as an innovative platform to revolutionize and catalyze the conduct of clinical trials greatly accelerating the translation of scientific findings into improvements in the prevention, diagnosis, and treatment of disease for our communities and patients. The NCCT will offer core services for patient recruitment and enrollment, trial administration and follow-up, and to gather real world data and evidence. The Clinical Trial Methods Center (CTMC) has been established within the Wake Forest University School of Medicine to provide the necessary tools and expertise that the NCCT will access and apply to deliver many of its core services.</p><p>
This position will be part of a team that will report to leadership in the NCCT and will provide overall management of the operational team and will provide study oversight project management for specific trials as needed.</p><p></p><p><b>
EDUCATION/EXPERIENCE</b></p><p></p><p>
Master's degree in a relevant discipline such as Health Administration, Nursing, Business, or Basic Science with three years of relevant management experience; or an equivalent combination of education and experience. Significant experience in managing clinical trial teams at a service line, therapeutic area or at a site level.</p><p></p><p><b>
ESSENTIAL FUNCTIONS</b></p><p></p><p>
This position will serve as a working manager who manages: Study Start-Up Navigators (SSUNs), Study Feasibility Project Managers (SFPMs) and Study Oversight Project Managers (SOPMs); and will also provide study oversight project management for specific trials as needed.
</p><p></p><p>I. Manager over Study Start-Up Navigators, Study Feasibility Project Managers and Study Oversight Project Managers who perform the following activities:</p><p></p><p><b>
Trial Navigation:</b> SSUNs serve as central point of contact for sponsors and study teams from first contact through trial activation, gather necessary information from sponsors and functional areas for trial feasibility assessments and trial activation, initiate trials in research systems, provide information to regulatory, budgeting and contracting teams for rapid trial start-up.</p><p></p><p><b>
Trial Feasibility Analyses: </b><b>SFPMs work</b><b> c</b>losely with local study teams, ancillary service providers and with informatics, recruitment and IT functional areas to render informed decisions as to whether the AHNCCT should take on specific trials.</p><p></p><p><b>
Study Oversight Services: </b>SOPMs serve as central points of contact for sponsors and study teams from trial activation through trial closeout. SOPMs facilitate set up of trials and can provide oversight of multisite trials, link local study teams to recruitment, informatics, budget/contracting, regulatory and IT teams. In addition, they can deploy 3rd party clinical trial coordinators to back up local study teams as needed.</p><p></p><p>
II. Study Oversight Project Management</p><p>
Study Oversight Manager helps to set up, monitor and manages the overall progress of trials.</p><ul><li>
Facilitates set up of trials at sites</li><li>
Facilitates and attends site initiation visits.</li><li>
Responsible for outreach to applicable physicians, care teams, etc to gain valuable information.</li><li>
Maintain working knowledge of clinical trials within research portfolio.</li><li>
Connects study staff members with training resources as necessary for compliance with policies.</li><li>
Monitors progress of the clinical trial until completion ensuring accrual, study activities and quality measures are met.</li><li>
Mitigates issues as they arise (e.g., difficulty meeting enrollment targets, etc.)</li><li>
Liaises with regulatory to monitor amendments, personnel changes, etc.</li><li>
Liaises with sponsor, investigator(s) and site staff throughout trial.</li><li>
Monitors resource demands throughout trial.</li><li>
Supports the deployment of coordinators and Advanced Care Providers to sites as needed for study conduct.</li></ul><p></p><p>
III. Performs other related duties incidental to the work described herein.</p><p></p><p><b>
SKILLS/QUALIFICATIONS</b></p><p>
Excellent verbal and written communication skills. Ability to work independently to develop processes. Ability to travel to affiliate sites and central offices as needed. Familiar with institutional/governmental regulations and guidelines related to clinical research including the elements of Good Clinical Practices.</p><p></p><p><b>
Our Commitment to You:</b></p><p></p><p>
Advocate Health offers a comprehensive suite of Total Rewards: benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more &ndash; so you can live fully at and away from work, including:</p><p></p><p><b>
Compensation</b></p><ul><li>
Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training</li><li>
Premium pay such as shift, on call, and more based on a teammate's job</li><li>
Incentive pay for select positions</li><li>
Opportunity for annual increases based on performance</li></ul><p></p><p><b>
Benefits and more</b></p><ul><li>
Paid Time Off programs</li><li>
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability</li><li>
Flexible Spending Accounts for eligible health care and dependent care expenses</li><li>
Family benefits such as adoption assistance and paid parental leave</li><li>
Defined contribution retirement plans with employer match and other financial wellness programs</li><li>
Educational Assistance Program</li></ul><p></p><p><b><br>
About Advocate Health</b></p><p></p><p>
Advocate Health is the third-largest nonprofit, integrated health system in the United States, created from the combination of Advocate Aurora Health and Atrium Health. Providing care under the names Advocate Health Care in Illinois; Atrium Health in the Carolinas, Georgia and Alabama; and Aurora Health Care in Wisconsin, Advocate Health is a national leader in clinical innovation, health outcomes, consumer experience and value-based care. Headquartered in Charlotte, North Carolina, Advocate Health services nearly 6 million patients and is engaged in hundreds of clinical trials and research studies, with Wake Forest University School of Medicine serving as the academic core of the enterprise. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Advocate Health employs 155,000 teammates across 69 hospitals and over 1,000 care locations, and offers one of the nation&rsquo;s largest graduate medical education programs with over 2,000 residents and fellows across more than 200 programs. Committed to providing equitable care for all, Advocate Health provides more than $6 billion in annual community benefits.</p><p>
</p>Under administrative review, provides overall administrative direction and coordination for policies, procedures, and programs for a large number of research studies and/or clinical trials. Supervises and provides expertise and guidance to staff regarding IRB submissions, communication, and implementation of HIPAA regulations, compliance and other regulatory issues. Requires the use of judgment and discretion in performing the assigned duties and responsibilities.</div>

National Center for Clinical Trials (NCCT) Clinical Trial Facilitation 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

<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>

<div><div><div>Abington Township, 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>

<div><div><div>New City, 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>

<div><div><div>Berkeley, 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>

Search 10000+ Clinical trials manager jobs near you this January. New roles added regularly across leading industries. Apply today.

10000 clinical trials manager jobs NEAR_ME

Clinical Research Manager

National Center for Clinical Trials (NCCT) Clinical Trial Facilitation Manager

Clinical Trial Manager I, IQVIA Biotech

Clinical Trial Manager I, IQVIA Biotech

Clinical Trial Manager I, IQVIA Biotech

Clinical Trial Manager I, IQVIA Biotech

Clinical Trial Manager I, IQVIA Biotech