clinical trial manager

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

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

Quest Diagnostics

<div><p><b>Clinical Trial Study Manager I - Seattle, WA, Monday to Friday, 8:00 AM to 5:00 PM</b></p>
<p><b>
Pay range: $90,500 - $162,950 / year</b><br>
Salary offers are based on a wide range of factors including relevant skills, training, experience, education, and, where applicable, certifications obtained. Market and organizational factors are also considered. Successful candidates may be eligible to receive annual performance bonus compensation.</p>
<div><b>
Benefits Information:</b><br>
We are proud to offer best-in-class benefits and programs to support employees and their families in living healthy, happy lives. Our pay and benefit plans have been designed to promote employee health in all respects &ndash; physical, financial, and developmental. Depending on whether it is a part-time or full-time position, some of the benefits offered may include:<br>
<ul><li>Day 1 Medical, supplemental health, dental &amp; vision for FT employees who work 30+ hours</li><li>Best-in-class well-being programs</li><li>Annual, no-cost health assessment program Blueprint for Wellness&reg;</li><li>healthyMINDS mental health program</li><li>Vacation and Health/Flex Time</li><li>6 Holidays plus 1 &quot;MyDay&quot; off</li><li>FinFit financial coaching and services</li><li>401(k) pre-tax and/or Roth IRA with company match up to 5% after 12 months of service</li><li>Employee stock purchase plan</li><li>Life and disability insurance, plus buy-up option</li><li>Flexible Spending Accounts</li><li>Annual incentive plans</li><li>Matching gifts program</li><li>Education assistance through MyQuest for Education</li><li>Career advancement opportunities</li><li>and so much more!</li></ul><br>
</div><p>The Clinical Trials Study Manager 1 is primarily responsible for coordinating the execution of clinical trial projects, including managing the scope, timeline, and budget of assigned projects. This position may also have direct line management responsibility of junior-level study management team members. They will have indirect management responsibility of team members supporting clinical trial projects.</p><div>
<div><div><div>Quest Diagnostics honors our service members and encourages veterans to apply.<br>
<br>
While we appreciate and value our staffing partners, we do not accept unsolicited resumes from agencies. Quest will not be responsible for paying agency fees for any individual as to whom an agency has sent an unsolicited resume.<br>
<br>
Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets or any other legally protected status.</div>
</div><br>
</div></div><ul><li>Review the contracted scope, budget, and timeline to develop a plan of action or multiple plans of action to successfully complete project.</li><li>
Coordinate with scientific and technical directors as the scientific leaders for the project.</li><li>
Coordinate with appropriate technical staff within the laboratory operations to ensure operational plan is achievable and appropriate resources are available for the scope.</li><li>
Coordinate with Director, Business Development throughout the life of the project to ensure scope, timeline and budget are well understood and also understand escalation path for communicating issues.</li><li>
Manage and own client relationship throughout the study</li><li>
Identify, track, and manage risks that may impact our ability to successfully complete the scope of the project in the timeline or budget available.</li><li>
Identify new or out of scope requests from customer and communicate with Business Development so contract modifications can be implemented.</li><li>
Maintain official project records from inception to completion including archiving.</li><li>
Ensure that contracted work is conducted within regulatory requirements (FDA, EMEA, GCLP).</li><li>
Develop overall project plan and maintain regular touch points to ensure that timelines are being met.</li><li>
Communicate with customer on regular operational items (project updates, scope alignment).</li><li>
Other duties as assigned.</li></ul><p><b>
Required Work Experience:</b></p><ul><li>
3-4 years of healthcare experience or equivalent education and experience.</li><li>
1-2 years of previous project management experience required.</li><li>
4-year degree is required.</li></ul><p><b>
Preferred Work Experience:</b></p><ul><li>
1-2 years of previous laboratory experience preferred.</li><li>
Previous experience in a GXP environment preferred.</li></ul><p><b>
Physical and Mental Requirements:</b></p><ul><li>
Ability to sit for extended periods of time.</li><li>
Ability to stand for extended periods of time.</li><li>
Must regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds.</li><li>
Ability to use fine motor skills to operate office equipment.</li><li>
Ability to receive and comprehend instructions verbally and/or in writing.</li><li>
Ability to use logical reasoning for simple and complex problem-solving.</li></ul><p><b>
Knowledge:</b></p><ul><li>
N/A</li></ul><p><b>
Skills:</b></p><ul><li>
Excellent verbal and written communication skills.</li><li>
Exceptional interpersonal skills and business acumen.</li><li>
Strong organizational skills; very detail-oriented and a self-motivated problem solver.</li><li>
Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.</li></ul></div>

Clinical Trial Study Manager I

INSIGHTEC

<div><p>Insightec is a growing medical technology company transforming patient lives through innovative incisionless surgery.</p><p></p><p><br>
Our culture is as unique as our people, a diverse global team, with different ideas, skills, interests, and cultural backgrounds driven by our core values &ndash; Our Patients, Integrity, Team, Quality and Innovation.</p><p></p><p><br>
Our dedication to making a real impact on the lives of millions of people and paving the path to a bright future for healthcare, is what bonds us as a Team. We work together in a dynamic collaborative environment to deliver successfully while believing and driving a life-work balance philosophy that encourages our employees to do things that are meaningful outside of work. Every role is significant, your voice is heard, and your ideas are encouraged. We challenge and empower our people to be great at what they do while providing a flexible work environment.</p><p></p><p><br>
Walking through our corridors, you will be inspired by stories of career journeys at Insightec. We take pride in growing internal talent and encourage our employees to achieve their professional ambitions. With employees in Israel - Haifa and K. Ono, Miami and Dallas, Shanghai, Tokyo and Europe, we offer in each region competitive perks and benefits.</p><p></p><p><br>
Do the most meaningful work of your career by joining us on our mission to transform tomorrows, today.</p><p></p><p><br>
The Clinical Project Manager serves as the clinical trial lead and will lead clinical trial initiatives for Insightec. You will ensure trial compliance, regulatory alignment, and operational efficiency while collaborating with cross-functional teams such as Medical Affairs, R&amp;D, and Quality &amp; Regulatory to advance Insightec&rsquo;s clinical pipeline. The Clinical Project Manager is expected to independently manage the clinical trial by effectively planning and executing the study to ensure quality of deliverables within the specified budget and timeframe.</p><p></p><p><b><br>
Key Responsibilities:</b></p><ul><li>
Clinical Trial Management:</li><li>
Lead and manage multiple clinical trials from initiation through to completion, ensuring adherence to study timelines and budgets.</li><li>
Collaborate with investigators, vendors, and cross-functional teams to ensure study execution and operational excellence including implementation of best practices such as quality by design.</li><li>
Oversee the preparation and review of trial-related documentation, including protocols, informed consent forms (ICFs), case report forms (CRFs), and clinical study reports.</li><li>
Support creation of investigator brochures, clinical evaluation reports, publications and other documentation such as annual reports as applicable.</li><li>
In partnership with R&amp;D Program Management, develop and drive cross functional study timelines related to trial setup and execution</li><li>
Other roles/responsibilities will be defined as needed</li></ul><p>
Team Leadership:</p><ul><li>
Drive the cross functional internal study team ensuring appropriate alignment, risk management and coordination across all participating functions.</li><li>
Successfully interface with Data Management, Biostatistics and Clinical Monitors to ensure seamless monitoring and data cleaning initiatives to meet study deliverables and timelines</li><li>
Foster a collaborative team environment focused on operational efficiency and continuous improvement.</li><li>
Regulatory and Compliance Oversight:</li><li>
Ensure that clinical trials are conducted in compliance with all applicable regulations and ISO 14155 and ICH-GCP guidelines as applicable.</li><li>
Lead submissions of clinical trial documents to central IRB/IECs as applicable and ensure insurance and recruitment materials are prepared appropriately.</li><li>
Support the preparation and submission of clinical trial applications, including IDEs, PMAs, 501K, INDs, and other regulatory documents with functional leads from regulatory affairs.</li><li>
Manage interactions with Regulatory Affairs and external vendors to ensure timely submissions and approvals.</li><li>
Budget and Resource Management:</li><li>
Develop and manage clinical trial budgets, ensuring efficient use of resources and timely financial reporting.</li><li>
Monitor and control trial costs to ensure alignment with project forecasts and company objectives.</li><li>
Negotiate contracts and budgets with clinical vendors and investigators.</li><li>
Vendor and Site Management:</li><li>
Oversee the selection and management of clinical research sites and clinical vendors (CROs, laboratories, etc.) and ensure they meet performance expectations.</li><li>
Develop strong relationships with clinical sites and external partners to ensure aggressive site startup, high-quality data collection and trial conduct.</li><li>
Perform risk assessment and management, addressing issues proactively to mitigate operational issues.</li></ul><p></p><p><b><br>
Qualifications:</b></p><ul><li>
Bachelor's or Master's degree in life sciences or a related field.</li><li>
7+ Years of experience as a Clinical Project Manager for Class II/III device studies</li><li>
3+ years of regulatory/clinical trial experience in the medical device industry</li><li>
Demonstrates working knowledge of clinical trial design</li><li>
Minimum of three years of experience developing clinical documents including protocols, informed consent, clinical study reports, and investigator brochures among other documents.</li><li>
Knowledge of financial principles in budgeting, budget negotiation, &amp; contracts management.</li><li>
Demonstrates data management skills, tracking study metrics, and adherence to study protocol</li><li>
Fluent in English with oral presentation and training capabilities</li><li>
Able and willing to travel as needed, up to 30%</li><li>
Expertise in GCP and regulatory requirements.</li><li>
Strong leadership and team management skills.</li></ul></div><p></p>

Clinical Project Manager

Johnson & Johnson

<div><p>At Johnson &amp; Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com</p><p><b>
Job Function:
</b></p>R&amp;D Operations<p><b>
Job Sub Function:
</b></p>Clinical Trial Project Management<p><b>
Job Category:</b></p>
Professional<p><b>
All Job Posting Locations:</b></p>
Raritan, New Jersey, United States of America, Remote (US)<p><b>
Job Description:</b></p><p><b>
About Innovative Medicine
</b></p><p>Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.</p><p>
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.</p><p>
Learn more at https://www.jnj.com/innovative-medicine</p><p><b>
We are searching for the best talent for a Sr. Local Trial Manager, Cross Therapeutic Area, to be located remotely within the United States.</b></p><p>
This is a remote role available in all states within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.</p><p>
Remote work options may be considered on a case-by-case basis and if approved by the Company.</p><p><b>
Purpose:</b></p><p>
A Senior Local Trial Manager is a mid-level trial management role with at least 2 years of clinical trial management or 3-5 years of clinical monitoring experience. This role is responsible for local management of a clinical trial in a country or countries.</p><p>
The Senior Local Trial Manager is the primary point of contact at a country level for assigned studies and has operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities as described in Global Clinical Operations (GCO) procedural documents. The Senior Local Trial Manager is responsible for coordinating and leading the local trial team to deliver quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements.</p><p>
The Senior Local Trial Manager actively contributes to process improvement; training and mentoring of Clinical Trial Assistants (CTA), Site Managers (SM), and Associate Local Trial Managers. The Senior Local Trial Manager may have some site management responsibilities. The Senior Local Trial Manager may also perform the role of Trial Delivery Manager (TDM)/Trial Delivery Leader (TDL) for single country as described in GCO procedural documents.</p><p><b>
You will be responsible for:</b></p><ul><li>
Collaborates with Functional Manager (FM) for country protocol feasibility (if applicable) and site feasibility assessment in conjunction with CTA (if applicable), SM, and TDM/TDL.</li><li>
Implements any local criteria for site selection.</li><li>
Ensures consistent conduct of Site Qualification Visits and instruct teams on appropriate follow-up of Site Qualification Visit report and country feasibility report.</li><li>
Recommends suitable sites for selection to participate in trial.</li><li>
Collaborates with the Program Delivery Leader (PDL), TDM/TDL, local management/Country Head and other study team members to select final site list.</li><li>
Contributes input to the study management documents at a country level or initiates development of these documents for a single country trial, as per SOPs.</li><li>
Leads and coordinates local trial team activities in compliance with SOPs, other procedural documents and applicable regulations.</li><li>
Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget. Including but not limited to: development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.</li><li>
Ensures that all Adverse Events (AE)/Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate.</li><li>
Maintains and updates trial management systems.</li><li>
Uses study tools and management reports available to analyze trial progress.</li><li>
Monitors country progress and initiates corrective and preventive actions (CAPA) when the trial deviates from plans and communicates study progress and issues to study management teams.</li><li>
May submit requests for vendor services and required to support vendor selection.</li><li>
In certain situations, may assist in negotiation of trial site contracts and budgets.</li><li>
Forecasts and manages country/local trial budget to ensure accurate finance reporting and trial delivered &ndash;within budget.</li><li>
Adheres to finance reporting deliverables and timelines.</li><li>
Attends/participates in Investigator Meetings as needed.</li><li>
May schedule and conduct a local/country investigator meeting.</li><li>
Will be expected to present and lead specific sessions and to facilitate discussion groups.</li><li>
Conducts local trial team meetings and provides or facilitates SM training when needed (i.e., implementation of study amendment-and changes in study-related processes).</li><li>
Reviews and approves Monitoring Visit Reports submitted by SM; identifies issues and/or trends across a trial project and escalates deviation issues to the TDM/TDL and FM as needed.</li><li>
Reviews and approves site and local vendor invoices as required. Manages local study supply, as required.</li><li>
Prepares country specific informed consent in accordance with procedural document/templates. Reviews and manages site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations.</li><li>
Organizes and ensures IEC/HA approvals, if applicable, and ensures that the trial is in compliance with local regulatory requirements.</li><li>
Works with SM to ensure CAPA is implemented for audits and inspection or any quality related visits.</li><li>
Complies with relevant training requirements.</li><li>
Acts as subject matter expert for assigned protocols.</li><li>
Develops strong therapeutic knowledge to support roles and responsibilities.</li><li>
May represent GCO on cross-functional teams.</li><li>
Acts as primary local/country contact for a trial.</li><li>
Establishes and maintains excellent working relationships with external stakeholders, in particular investigators, study trial coordinators, and other site staff, and internal stakeholders.</li><li>
Actively contributes to process improvement, training and mentoring of CTAs, SMs, and other LTMs.</li><li>
May be asked to conduct accompanied site visits with SM as delegated by FM.</li><li>
May be required to provide guidance to Assoc LTMs.</li><li>
May assume additional responsibilities or special initiatives such as &ldquo;Champion&rdquo; or &ldquo;Subject Matter Expert&rdquo;.</li><li>
May represent functional area in process initiatives as required.</li></ul><p>
This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.</p><p><b>
Principal Relationships:</b></p><ul><li>
Primary Reporting Structure: Reports to a FM.</li><li>
Primary interfaces: FM, CTA, SM, TDM/TDL, Study Responsible Physicians (SRP)/Study Responsible Scientists (SRS), Compliance Managers/Specialists, Local Safety Officer.</li><li>
Other Internal Interfaces: R&amp;D Country Head, Strategic Account Lead (SAL), Contracts &amp; Centralized Services (CCS), R&amp;D clinical team (e.g., SRP), data management and Medical Affairs (when applicable).</li><li>
External Interfaces: Health Authorities, Ethics Committees, Investigational sites, local vendors and others as required.</li></ul><p><b>
Qualifications / Requirements:</b></p><ul><li>
A minimum of a BA or BS degree in Pharmacy, Nursing, Life Sciences or related scientific field is required.</li><li>
Minimum of 2 years of clinical trial management experience or a total of at least 5 years of clinical trial monitoring and/or clinical trial management experience. However, other relevant experiences and skills may be considered by the hiring manager when considering the candidate&rsquo;s eligibility.</li><li>
Neuroscience therapeutic area experience is required for the position.</li><li>
Should have a good understanding of the drug development process including GCP and local regulatory requirements.</li><li>
Willingness to travel with occasional overnight stay away from home.</li><li>
Minimum of 2 years of leadership experience.</li><li>
Computer skills required.</li><li>
Proficient in speaking and writing the country language and English language.</li><li>
Excellent written and oral communication skills.</li><li>
Demonstrated potential to be influential.</li><li>
Some experience in mentoring/coaching and providing training to other LTMs, SMs, and CTAs preferred.</li><li>
The ability to lead initiative/small teams.</li><li>
Flexible mindset and ability to work in a fast-changing environment.</li><li>
Ability to work on multiple trials in parallel.</li><li>
Ability to anticipate obstacles and proactively provide solutions.</li><li>
May be assigned to high priority projects.</li></ul><p><i>
The anticipated base pay range for this position in the US is $89,000-$143,750.
</i></p><p>The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation&rsquo;s performance over a calendar/ performance year. Bonuses are awarded at the Company&rsquo;s discretion on an individual basis.</p><p>
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.</p><p>
Employees may be eligible to participate in the Company&rsquo;s consolidated retirement plan (pension) and savings plan (401(k)).</p><ul><li>
Employees are eligible for the following time off benefits:
</li><li>Vacation - up to 120 hours per calendar year</li><li>
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year</li><li>
Holiday pay, including Floating Holidays - up to 13 days per calendar year</li><li>
Work, Personal and Family Time - up to 40 hours per calendar year</li></ul><p>
For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits
</p><p>This job posting is anticipated to close on October 31st, 2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.</p><p>
Johnson &amp; Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
</p><p>Johnson &amp; Johnson is committed to providing an interview process that is inclusive of our applicants&rsquo; needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.</p><p>
#LI-Remote</p></div>

Senior Local Trial Manager, Cross Therapeutic Area

ICON plc

<div>Local Trial Manager - 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>
The L-LTM role will be accountable/responsible for ensuring top-quality end-to-end trial delivery at a country level, managing the consistency of Local Trial Management duties and processes. The L-LTM will serve as the country-level single point of contact on the study for internal partners. While the L-LTM may delegate tasks to other LTMs or roles on the study, the L-LTM remains accountable for successful completion of those tasks.</div><div></div><div>
The L-LTM will manage and oversee the following throughout the study:</div><div></div><ul><li><div>
Central IRB and other local vendors (Greenphire, Drug Destruction services, etc.&hellip;) including set up of vendor purchase orders, invoice review and approval, and change-orders, as applicable.</div></li><li><div>
Execution of local milestones from feasibility through study close out.</div></li><li><div>
Resourcing of country-level roles, including support with transitions, in collaboration and agreement with the study Functional Manager (FM).</div></li><li><div>
Inspection Readiness and AQR at the country level.</div></li><li><div>
Close collaboration with the assigned Local Trial Manager(s) (LTMs), Lead Site Manager (LSM), Site Managers (SMs), Clinical Trial Associates (CTAs), and Site Contract Managers (SCMs) to outline accountabilities/responsibilities and provide support and training, where necessary.</div></li><li><div>
Efficient communication with the Clinical Trial Managers (CTMs), Clinical Operations and the Global Trial Leader (GTL) to oversee trial excellence.</div></li><li><div>
Country level ad hoc meetings during any phase of the study that are needed to address unexpected circumstances that might impact country or study level deliverables.</div></li><li><div>
Close partnership with the study FM to provide updates, discuss hurdles, timelines/resources, and potential risks, and assist with documentation, such as storyboards, lessons-learned, metrics, etc., that may be required by leadership.</div></li></ul><div></div><div>
What you need to have</div><ul><li><div>
BA/BS degree.</div></li><li><div>
Degree in a health or science related field.</div></li><li><div>
2 years of local trial management or mutually agreed clinical trial experience.</div></li><li><div>
Start-up &amp; Database Locks/Cleaning experience preferred</div></li><li><div>
Oncology Solid Tumor experience required</div></li><li><div>
Specific therapeutic area experience may be required depending on the position.</div></li><li><div>
Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures.</div></li><li><div>
Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home according to business needs.</div></li><li><div>
Proficient in speaking and writing the country language and English. Good written and oral communication skills as appropriate</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>

Local Trial Manager - Oncology - Home Based (US)

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