clinical trials manager

University of Nebraska Medical Center

<div><div>Job Description
<div><div><div><div><div><div><div><h2 class="jobSectionHeader"><b>Job Summary:
</b></h2></div><div><p>The Project Manager is responsible for assisting the UNMC Principal Investigators and the Administrator in the overall project management, and implementation of Nephrology and Kidney Transplant clinical trials and research projects, as well as function as the primary contact for the industry trials that will ensure successful participation of our site in clinical trials. Research projects and campus collaboration.
</p><p>Provide tracking and preparation of study specific documents according to FDA regulations. Oversees training of personnel and project teams as appropriate. Works to ensure trials and projects move forward based on both time and budget. Plays an integral role in the communication between sponsors, sites and team members and act as a liaison with other divisions necessary to complete the study.
</p><p>In addition to project manager responsibilities, this individual is responsible for supervision assigned team members of the Division of Nephrology clinical trials working group. This may include direct supervision and overseeing training of site personnel and project team members as appropriate.
</p><p><b>View full description by selecting Additional Info below.
</b></p><p>Additional Info
</p></div></div><div><div><h2 class="jobSectionHeader"><b>About Us:
</b></h2></div><div><p>To learn more about the University of Nebraska, visit the sites below.
</p><p>University of Nebraska Strategic Plan &ldquo; <b>Odyssey to Extraordinary&rdquo; </b>https://nebraska.edu/strategic-plan
</p><p><b>Get to know Nebraska </b>https://nebraska.edu/get-to-know-nebraska
</p><p><b>University of Nebraska Medical Center Campus </b>https://www.unmc.edu/aboutus/index.html and https://www.unmc.edu/aboutus/facts.html
</p><p><b>University of Nebraska Faculty &amp; Staff Benefits </b>https://nebraska.edu/faculty-and-staff
</p></div></div><div><div><h2 class="jobSectionHeader"><b>Required Qualifications:
</b></h2></div><div><ul><li>Bachelor's degree in Health Science or related field.
</li><li>2 years clinical research project management to include data collection or data management
</li><li>Microsoft Excel,Microsoft Word,Microsoft Outlook
</li></ul><p>Will consider six years related education and/or experience combined of which two years must include related post high school education<br>
</p><p></p><ul><li>Excellent organizational skills
</li><li>Knowledge of clinical research
</li><li>Excellent verbal and written communication skills required
</li><li>Computer literacy and familiarity with maintenance of computer databases
</li><li>Ability to work effectively with other team members
</li><li>Ability to prioritize multiple tasks/responsibilities
</li><li>Strong interpersonal skills
</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>Preferred Qualifications:
</b></h2></div><div>Bachelor's degree in Nursing, Healthcare Administration<br>
<ul><li>
</li></ul><p></p><ul><li>Nephrology
</li><li>Knowledge of clinical research trials
</li><li>Medical terminology
</li><li>Database Systems
</li><li>Previous experience working with physicians
</li>Previous work in kidney disease and/or kidney transplantation<br>
<li>
</li></ul></div></div><p></p><div><div><h2 class="jobSectionHeader"><b>Compliance Requirements:
</b></h2></div><div><ul><li>Physical Exam
</li><li>Drug Screen
</li><li>Background Check
</li><li>Child &amp; Adult Sexual Abuse Registry Request and Check
</li><li>Education Credentials Check
</li><li>Immunizations
</li></ul></div></div></div></div></div></div></div></div><div>Information at a Glance<div><div>
</div></div><div><div><div><div>Req Id: 1555
</div></div></div></div><div><div><div><div>Campus Name: University of Nebraska Medical Center (UNMC)
</div></div></div></div><div><div><div><div>Org Unit: Int Med Nephrology UNMC
</div></div></div></div><div><div><div><div>Job Location: Omaha, NE 68198
</div></div></div></div><div><div><div><div>Application Review Date: 10/30/25
</div></div></div></div><div><div><div><div>Open Until Filled: Yes
</div></div></div></div><div><div><div><div>Advertised Salary: $53,000 - $79,500/annual
</div></div></div></div><div><div><div><div>Job Type: Full-Time
</div></div></div></div><div><div><div><div>Worksite Eligibility: Hybrid
</div></div></div></div><div><div><div><div>Benefits Eligible: Yes</div></div></div></div></div></div><p></p>

Research Project Coordinator

Dana-Farber Cancer Institute

<b>Job Ref:</b><br>
46863
<br><br>
<b>Location:</b><br>
450 Brookline Ave, Boston, MA 02215
<br><br>
<b>Category:</b><br>
Clinical Research
<br><br>
<b>Employment Type:</b><br>
Full time
<br><br>
<b>Work Location:</b><br>
<b>Remote:</b> occasional time on campus
<br><br>
Overview
<br><br>
The Clinical Research Project Manager I is responsible for the day-to-day coordination and management of Cutaneous Oncology clinical trial activities, primarily focusing on multi-center, PI-initiated trials. They ensure trial and site startup coordination, train site research staff, handle regulatory submissions, track safety events, and communicate with regulatory authorities. Reporting to disease group managers and/or Clinical Trials Office (CTO) leadership the Clinical Research Project Manager I identifies project plan variances and develops contingency plans to maintain project milestones. They may also oversee operational and training aspects of the EPIC/OnCore application, working closely with faculty, staff, and stakeholders to develop infrastructure, procedures, and tracking systems for project management services. This role requires independent work under general supervision within their disease group or CTO, with a focus on ensuring compliance and efficient trial execution.
<br><br>
This position's work location is fully remote with occasional time on-campus in Boston, MA. The selected candidate may only work remotely from a New England state (ME, VT, NH, MA, CT, RI).
<br><br>
Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.
<br><br>
Responsibilities
<br><br>
<b>Day-to-Day Project Oversight:</b> Manage the daily operations of assigned clinical trials, ensuring efficient execution and adherence to timelines while maintaining compliance with clinical trial regulations. This involves monitoring budgets, resources, and coordinating with cross-functional teams to meet project milestones.
<br><b>Trial Master File (TMF) Development and Maintenance:</b> Develop and maintain the TMF, ensuring all essential documents are organized, accessible, and compliant with Good Clinical Practice (GCP) standards. Regular updates are conducted to ensure compliance with regulatory standards and institutional policies.
<br><b>Protocol and Consent Form Development:</b> Assist the Principal Investigator (PI) in developing protocols and consent forms for initial applications and amendments, ensuring they meet regulatory requirements and are easily understood by participants. This requires translating complex scientific concepts into clear, concise documents.
<br><b>Clinical Trial Phases Management:</b> Initiate, plan, and oversee the start-up, active, and close-out phases of clinical trials, particularly for PI-initiated and multi-center studies. Coordination with stakeholders, including site staff and external partners, ensures smooth transitions between phases and adherence to timelines.
<br><b>Case Report Form Design and Database Maintenance:</b> Design case report forms based on PI directives and maintains study-related databases, ensuring data integrity and compliance with clinical trial standards. Prepare protocol-related reports and data summaries to support ongoing research activities and decision-making.
<br><b>Administrative Support:</b> Schedule research team meetings and conference calls, facilitate mailings, and perform other project-related administrative tasks to ensure effective communication and coordination among team members and external collaborators.
<br><br>
Qualifications
<br><br>
Bachelor’s degree in a field relevant to clinical research required.
<br>Three (3) years of experience in clinical research or project management, ideally within multi-center oncology trials, with specific experience in managing clinical trial operations.
<br>Experience in an academic institution with a proven track record of success in the clinical research field is preferred, particularly in roles involving clinical trial coordination and management.
<br><br>
<b>KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:</b><br>
Basic understanding of clinical trial processes and regulatory requirements, including Good Clinical Practice (GCP) guidelines.
<br>Familiarity with trial management software and tools, such as EPIC and OnCore, for efficient trial coordination.
<br>Awareness of data management practices and documentation standards, with an emphasis on compliance and accuracy.
<br>Strong organizational and time management skills to handle multiple tasks efficiently, ensuring adherence to clinical trial timelines.
<br>Effective communication skills for interacting with research staff, stakeholders, and regulatory authorities.
<br>Basic problem-solving skills to address project-related issues, with the ability to anticipate and mitigate potential challenges.
<br>Ability to work independently under general supervision, while maintaining compliance with clinical trial protocols.
<br>Capability to learn and adapt to new procedures and technologies, including updates in clinical trial regulations.
<br>Competence in maintaining accurate records and documentation, ensuring compliance with regulatory standards.
<br>Understanding of ethical considerations and patient confidentiality in clinical trials.
<br>Ability to collaborate effectively with cross-functional teams and external partners to support trial objectives.
<br><br>
Pay Transparency Statement
<br><br>
The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate’s relevant experience, skills and qualifications.
<br><br>
For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA).
<br><br>
<b>Salary range:</b> $76,911 - $85,295
<br><br>
At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are committed to having faculty and staff who offer multifaceted experiences. Cancer knows no boundaries and when it comes to hiring the most dedicated and compassionate professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.
<br><br>
Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.
<br><br>
EEOC Poster

Clinical Research Project Manager - Cutaneous

National Reference Laboratory

<div></div><div><div><div><div><div><div><div>ID</div>
<div>2025-4834
</div></div><div><div>Category</div>
<div>Clinical Operations
</div></div><div><div>Asset : Name</div>
<div>IROS (Insights Research Organization &amp; Solutions)
</div></div><div><div>City</div>
<div>Abu Dhabi
</div></div></div></div></div></div><h2 class="jobSectionHeader"><b>Overview
</b></h2><div><div><div><div>M42&rsquo;s Integrated Health Solutions (IHS) platform drives transformative national programs and population health initiatives, addressing global health challenges through precision, prevention, and predictive care. Flagship initiatives include the Emirati Genome Program (EGP), the Abu Dhabi BioBank, and Biogenix Labs, which together advance personalized medicine, drug discovery, and biobanking excellence. Environmental Sciences complements these efforts by analyzing non-human factors impacting health, while IROS (Integrated Research Organization Solutions) powers clinical innovation through high-quality research.</div><div></div><div><br>
We are seeking a Clinical Research Manager to join IROS, the UAE&rsquo;s first homegrown Contract Research Organization (CRO), dedicated to raising the bar in clinical trial management and research excellence.</div>
</div></div></div><h2 class="jobSectionHeader"><b>Responsibilities
</b></h2><div><div><div><ul><li>Lead, mentor, and manage a team of Clinical Research Associates (CRAs).</li><li>
Oversee clinical trial execution with adherence to GCP, regulations, and SOPs.</li><li>
Collaborate with Clinical Project Managers to align on deliverables and resources.</li><li>
Conduct on-site performance evaluations and manage staff development plans.</li><li>
Drive process improvements and ensure consistent compliance across studies.</li><li>
Handle administrative oversight, including approvals, performance reviews, and onboarding.</li></ul>
</div></div></div><h2 class="jobSectionHeader"><b>Qualifications
</b></h2><div><div><div><ul><li>Bachelor&rsquo;s degree in Life Sciences (or equivalent).</li><li>
5+ years&rsquo; experience as a CRA/Monitor and at least 4 years in a lead/project role.</li><li>
Proven ability to lead teams within global/multi-regional clinical trials.</li><li>
Strong knowledge of clinical research processes, ICH/GCP guidelines, and regulatory requirements.</li><li>
Excellent communication, organizational, and leadership skills.</li><li>
Experience with electronic data capture (EDC) and budget management preferred.</li></ul></div></div></div></div><div></div>

Clinical Research Manager

Kyverna Therapeutics

<div><div>Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be at the forefront of cell therapy innovation by joining scientists, industry veterans and healthcare visionaries and help transform how autoimmune diseases are treated</div><div></div><div><br>
The Senior Clinical Trial Manager (Sr CTM) will lead the operational delivery of one or more cell therapy clinical trials from study design through close-out. Sr. CTM will be accountable for timelines, budget, quality, vendor &amp; CRO oversight, and cross-functional coordination for the assigned studies. Given the complexity of cell therapies (manufacturing, specialized logistics, regulatory, unique site burden), this role requires deep knowledge of clinical operations plus specific experience in cellular therapies or advanced biologics.</div><div>
</div><div><b>
Title:</b> Sr. CTM</div><div><b>
Location:</b> Remote</div><div><b>
Reports to</b>: Sr. Director, Clinical Operations</div>
<h3 class="jobSectionHeader"><b>Responsibilities</b></h3><ul><li>
Lead and manage the day-to-day operational execution of assigned cell therapy trials: study startup, site activation, enrollment, monitoring, close-out.</li><li>
Develop and manage study timelines, budgets, forecasts, and related operational metrics.</li><li>
Partner with external vendors / CROs / service providers (monitoring, labs, imaging, manufacturing/supply chain for cell product) to ensure high quality and timely deliverables.</li><li>
Serve as the primary cross-functional operational contact for study teams (clinical operations, data management, biostatistics, regulatory, safety/pharmacovigilance, manufacturing, supply chain, medical affairs, quality).</li><li>
Ensure compliance with regulatory and quality standards (FDA, EMA, ICH-GCP, relevant local regulations) and internal SOPs.</li><li>
Participate in protocol development and amendments, informed consent form (ICF) review, CRF/data tool development, TMF (Trial Master File) setup &amp; maintenance, monitoring plan, data review plan, drug/cell-product accountability and reconciliation.</li><li>
Oversee site feasibility, selection, contracting, start&#8208;up (site initiation visits, training, enrollment &amp; retention strategies) and close&#8208;out activities.</li><li>
Monitor study progress, identify risks/issues (enrollment delays, monitor/vendor performance, budget overruns, data quality issues) and implement mitigation strategies.</li><li>
Foster effective communication across study teams, escalate issues to senior leadership as needed.</li><li>
Ensure preparation for audits/inspections, maintain high standards of documentation readiness.</li><li>
Contribute to lessons-learned and process improvement initiatives, particularly around cell-therapy-specific operational challenges (e.g., chain of identity/chain of custody, logistics of product, unique site training).
</li><li>Review invoices and track study budget according to the forecast, working closely with finance and clinical business operations.</li><li>
Develop study documents and tools including study, informed consent forms, project plans, budgets, study templates, and other materials as needed.</li></ul><h3 class="jobSectionHeader"><b>
Qualifications
</b></h3><ul><li>B.S. degree with minimum 7 years of experience in clinical operations including managing clinical trials in biotech, pharmaceutical.</li><li>
Strong clinical study conduct experience from start-up through close-out.</li><li>
Strong leadership, effective decision making, and problem-solving skills required.</li><li>
Established Cell Therapy /CAR T study experience required.
</li><li>Working knowledge of relevant GCPs and FDA/EMA regulations.</li><li>
Knowledgeable of current ICH GCP guidelines and applicable regulations.</li><li>
Ability to work effectively with minimal supervision and multi-task activities to effectively manage deliverables across all trials.</li><li>
Experience in small/mid biotechnology environment (startup mindset)</li><li>
Excellent written and verbal communication skills</li></ul><div>
The salary range for this position is from $165,000 to $185,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position, and the actual salary may vary based on various factors, including without limitation individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data. This position is also eligible for bonus, benefits, and participation in Company&rsquo;s stock option plan.</div><div></div><div><br>
Kyverna is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Kyverna is committed to the principle of equal employment opportunity for all employees and does not discriminate on the basis of race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets</div></div>

Sr. Clinical Trial Manager

Thermo Fisher Scientific

<div><p><b>Work Schedule</b></p>
Standard (Mon-Fri)<p></p><p><b>
Environmental Conditions</b></p>
Office<p></p><p><b>
Job Description</b></p><p></p><p><br>
Job Description</p><p>
At Thermo Fisher Scientific, you&rsquo;ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on &ndash; now and in the future.</p><p></p><p><b>
Summarized Purpose:</b></p><p>
Accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. Interprets data on complex issues and makes good business decisions with support from line management. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. Typically works independently on projects of moderate to high complexity, and may assume regional lead or Clinical Study Manager responsibilities.</p><p></p><p><b>
Key Responsibilities</b>:</p><ul><li>
Manages all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Lead CTM responsibilities on regional level, Clinical Study Manager (CSM) responsibilities or take on additional responsibilities; e.g. process improvements, manage complex programs, have wider management or project coordination responsibilities.</li><li>
Ensure efficient and thorough study start-up by overseeing the Clinical team of the CROs and working closely with other relevant team members involved in the study set up (DM, Reg, CMC etc&hellip;): ensure feasibility report are exhaustive, Review site feasibility reports as per oversight plan , support the CPM in site selection, verify timely collection of essential study documents, such as regulatory and ethics committee documents for submission, and by controlling that all set up activities are performed prior to each site initiation, as per the oversight plan.</li><li>
Support and ensure that all specific EDC system tasks under the clinical responsibility are completed and achieved according to the defined timelines without jeopardising the start of a trial.</li><li>
Support the Clinical CRO in the training of the CRAs on all study specific operational activities and participate in the organisation and preparation of the monitor and investigator meetings in collaboration with the other study team members (Corporate and/or affiliates, CROs as appropriate)</li><li>
Customize site Key Risk/Performance Indicator template and follow these KRIs/KPIs at frequency agreed in the oversight plan</li><li>
Validate the final clinical study documents (such as study manual, monitoring plan &hellip;) prepared by the Clinical CRO.</li><li>
Develops clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contributes to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.</li><li>
Collaborates with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicates with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department.</li><li>
Ensures achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitors clinical trials to assess performance and ensure contractual obligations are met. May routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.</li><li>
May coordinate all start-up activities, and ensures that essential document quality meets the expectation of Regulatory Compliance Review. Ensures timely regulatory submissions (if appropriate) are addressed. Reviews and follows up on all questions raised by ethics committees. Responsibilities may vary based on project timelines.</li><li>
Provides input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.</li><li>
In North America, where assigned to GPHS (Government &amp; Public Health Studies) projects, may have limited line management responsibilities</li></ul><p>
Communicates with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues</p><p><b>
Knowledge, Skills and Abilities</b>:</p><ul><li>
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years). 1+ year of leadership responsibility</li><li>
MUST HAVE previous experience in both on site monitoring &amp; in a CTM role</li><li>
Rare Disease Experience is HIGHLY preferred</li><li>
Travel: 40-50% Travel; US Travel</li><li>
Previous On Site Monitoring Experience</li><li>
Advanced mentoring/leadership/supervisory skills</li><li>
Excellent clinical trials monitoring skills; ideally remote AND onsite experience</li><li>
Demonstrated understanding of or ability to learn the company&rsquo;s SOPs, WPDs, and relevant regulations(e.g. ICH/GCP, FDA guidelines)</li><li>
Strong organizational and negotiation skills</li><li>
Strong attention to detail</li><li>
Advanced written and oral communication skills</li><li>
Strong knowledge of English language and grammar</li><li>
Demonstrated use of computer to include data entry, archival and retrieval</li><li>
Ability to travel as needed</li><li>
Excellent team player with team building skills</li><li>
Excellent interpersonal and conflict resolution skills</li><li>
Advanced ability to utilize problem-solving techniques applicable to constantly changing environment</li><li>
Solid knowledge of medical/therapeutic areas and medical terminology</li></ul><p></p><p>
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.</p><p>
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.</p></div><p></p>

Senior Clinical Trial Manager, FSP

CenExel Clinical Research

<p></p><div><p><b>About Us:</b></p><br>
<p>
</p><p>Each of CenExel&rsquo;s research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success.</p><br>
<p></p>
<p>
Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.</p><br>
<p></p>
<p><b>
Job Summary:
</b></p><p>Responsible for the management of clinical research studies and the personnel assigned to those studies, under the direction of the Clinical Director.</p><br>
<p></p>
<p><b>
Essential Responsibilities and Duties:</b></p>
<ul>
<li>Manages all assigned clinical staff.</li>
<li>Reads and understands assigned protocols and leads and interfaces on such protocols with the study staff to achieve successful execution within appropriate timeframes.</li>
<li>Conducts Site Qualification Visits, as assigned. Schedules and oversees Investigator Meeting arrangements, conducts initiation, study start-up, and team meetings. Oversees scheduling and conduct of monitor visits. Represents the clinical team during site visits.</li>
<li>Oversees preparation of, or personally prepares study-specific source documents for new protocols. Reviews and modifies sponsor-provided source documents, when necessary. Assists Study Coordinators in duties, as necessary.</li>
<li>On assigned protocols, assists to oversee delivery, shipment, inventory, storage, calibration and accountability of investigational products, supplies and equipment required to conduct clinical investigations.</li>
<li>Ensures optimum team function by assisting Clinical Research Coordinators with site start up, enrollment and study execution. Is present for first patient randomized on each study.</li>
<li>Fields protocol questions from Clinical Research Coordinators.</li>
<li>Acts as the project lead, liaising between sites, investigators, monitors, clinical research coordinators, physicians, laboratory, pharmacy staff, and other study team members. Assists with study in-services and other training needs as needed.</li>
<li>Oversees the following aspect of trials but is not limited to: Vendors, Client Satisfaction, Recruitment, Quality, Study Start-up and Trial Outcomes.</li>
<li>Monitoring the progress and completion of routine action items and ensuring timely follow-up.</li>
<li>Ensuring proper internal procedures are followed and documentation is obtained from coordinators for approval of retest, unscheduled visits, admits, AE treatments, etc.</li>
<li>Hires, trains, supervises, and evaluates personnel. Champions and enforces the strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site Working Practices, protocol, and company guidelines and policies. Retrains and implements corrective and preventative actions, as needed.</li>
<li>Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.</li></ul><br>
<p></p>
<p><b>
Education/Experience/Skills:</b></p>
<ul>
<li>Bachelor's degree in related field or equivalent experience is preferred.</li>
<li>Minimum of three years of Clinical Research Coordinator or equivalent experience.</li>
<li>Ability to independently coordinate and manage complex protocols and to lead, motivate and train a clinical research team.</li>
<li>Experience managing and leading staff and implementing personnel procedures.</li>
<li>Professional image, upholding the company vision in actions, demeanor, and appearance.</li>
<li>Must be able to effectively communicate verbally and in writing.</li></ul><br>
<p></p>
<p><b>
Working Conditions
</b></p><div><ul><li>Indoor, Clinic and Office environment.</li></ul>
<ul><li>Essential physical requirements include sitting, typing, standing, walking.</li></ul>
<ul><li>Lightly active position, occasional lifting of up to 20 pounds.</li></ul>
<ul><li>Reporting to work, as scheduled, is essential.</li></ul>
<ul><li>On site work arrangement.</li></ul></div><br>
<p></p>
<p>
CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.</p><p></p><p><br>
Equal Opportunity Employer<br>
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.</p></div>

Clinical Trial Manager

ICON plc

<div>Clinical Trial Assistant - Oncology - Home Based (US)<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>
What you will be doing:</div><div></div><div>
Services/deliverables include the management of all documents and logistical and administrative tasks related to trial feasibility, start-up, execution and close out of clinical trials.</div><div></div><div>
 Ensures trial related activities are compliant with GCO SOPs, policies, code of Good Clinical Practice (GCP), Health Care Compliance requirements (HCC) and local regulatory requirements. Further services/deliverables will include technical regulatory document review, including Informed Consent Forms. Partners with the Local Trial Manager (LTM) and Site Manager (SM) to ensure overall site management while performing trial related activities for assigned protocols.</div><div></div><ul><li><div>
Services rendered will adhere to applicable client SOPs, WIs, policies, local regulatory requirements, etc.</div></li><li><div>
Comply with relevant training requirements.</div></li><li><div>
Provides the following deliverables: tracks progress of the clinical trial, manages study data, budget, investigational products, mailings and correspondence and other relevant tasks in support of the LTM/TM and SM.</div></li><li><div>
Maintains trial, country and site level protocol information in trial management systems, including but not limited to relevant systems to ensure appropriate safety update distribution.</div></li><li><div>
Ensures current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site(s) within required timeframes.</div></li><li><div>
Collects and files all documents throughout the trial and post-trial. Uses appropriate systems to ensure file completeness at designated study milestones. Coordinates archiving of paper study relevant documents/files.</div></li><li><div>
Ensures audit and inspection readiness.</div></li><li><div>
Provide process improvement suggestions if applicable.</div></li><li><div>
Negotiates site requested changes to the confidential disclosure agreement; checks investigators and IEC/IRBs against exclusion databases, IEC/IRB registrations and alerts as applicable; and other relevant tasks in support of study feasibility and site assessments.</div></li><li><div>
Collects/prepares documents required for study, such as start-up/submission to the IEC/IRB and HA, in support of the LTM/TM/SM where applicable.</div></li><li><div>
Collects and tracks financial disclosure information at appropriate time points in accordance with procedural documents.</div></li><li><div>
Prepares study files for investigational sites and co-ordinates the development of associated documents and review them for completeness and accuracy.</div></li><li><div>
Provides updates to study specific internal data repositories to ensure availability of trial documents to the study team.</div></li><li><div>
If requested, manage study budget including Affiliate spend, vendor management (including reconciliation of invoices and final budget), liaising with Accounts Payable as necessary.</div></li><li><div>
If requested, organize training for SM(s) and/or SIV/small investigator meetings.</div></li><li><div>
If applicable, region-specific deliverables will be specified.</div></li></ul><div></div><div>
You are:</div><ul><li><div>
BA/BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience).</div></li><li><div>
1-2 years of relevant clinical trial experience with associated skill sets preferred.</div></li><li><div>
Proficient in English language (spoken and written).</div></li><li><div>
Strong knowledge of MS Office (Word, Excel, Access, Outlook, Explorer and PowerPoint).</div></li><li><div>
Strong interpersonal and negotiating skills.</div></li><li><div>
Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment.</div></li><li><div>
Perform activities in a timely and accurate manner.</div></li><li><div>
Experience in VeevaVault TMF is desirable</div></li><li><div>
To qualify, applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status</div></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>

Clinical Trial Assistant - Oncology - Home Based (US)

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