clinical operations manager

Syneos Health

<div><p><b>Description</b>
</p>Clinical Operations Manager - Systems&amp;Process Improvement - FSP - Istanbul<p></p><p>
Syneos Health&reg; is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.</p><p>
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.</p><p></p><p>
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you&rsquo;ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.</p><p></p><p>
Discover what our 29,000 employees, across 110 countries already know:</p><p></p><p><b>
WORK HERE MATTERS EVERYWHERE</b></p><p></p><p>
Why Syneos Health</p><ul><li>
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.</li><li>
We are committed to our Total Self culture &ndash; where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.</li><li>
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives &ndash; we&rsquo;re able to create a place where everyone feels like they belong.</li></ul><p></p><p><b>
Job Responsibilities</b></p><p></p><h1 class="jobSectionHeader"><b>
Clinical Operations Manager (COM) &ndash; Systems &amp; Process Improvement - Istanbul - Sponsor Dedicated</b></h1><ul><li><h2 class="jobSectionHeader"><b>
We are looking for a </b><b>Clinical Operations Manager</b><b> with a strong focus on </b><b>systems optimization and process improvement</b><b> rather than traditional trial oversight. This is a unique role designed for someone who understands how clinical programs and operational systems work &mdash; and more importantly, how they can work better.</b></h2></li><li><h2 class="jobSectionHeader"><b>
Review and assess existing clinical systems, tools, and workflows to identify gaps and improvement opportunities.</b></h2></li><li><h2 class="jobSectionHeader"><b>
Propose, develop, and implement practical solutions to increase efficiency and quality in clinical operations.</b></h2></li><li><h2 class="jobSectionHeader"><b>
Collaborate with cross-functional teams (Clinical Operations, Data Management, IT, Quality, etc.) to optimize system usage.</b></h2></li><li><h2 class="jobSectionHeader"><b>
Lead or support pilot initiatives, process redesign, and system rollouts.</b></h2></li><li><p>
Additionally performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and with guidance develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.</p></li><li><p>
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient&rsquo;s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.</p></li><li><p>
For the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes<br>
Conducts Source Document Review of appropriate site source documents and medical records<br>
Verifies required clinical data entered in the case report form (CRF) is accurate and complete<br>
Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines<br>
Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture<br>
Verifies site compliance with electronic data capture requirements</p></li></ul><p></p><p>
Qualifications:</p><ul><li><p>
Bachelor&rsquo;s degree or RN in a related field or equivalent combination of education, training and experience</p></li><li><p>
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements</p></li><li><p>
Must demonstrate good computer skills and be able to embrace new technologies</p></li><li><p>
Excellent communication, presentation and interpersonal skills</p></li><li><p>
Ability to manage required travel of up to 75% on a regular basis</p></li><li><p>
US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk.</p></li></ul><p></p><p><b>
Get to know Syneos Health</b></p><p><br>
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.</p><p></p><p>
No matter what your role is, you&rsquo;ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.</p><p></p><p>
http://www.syneoshealth.com</p><p></p><p><b>
Additional Information</b></p><p><br>
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.</p><p><b>
Summary</b>
</p>Roles within the Clinical Trial Management job family are responsible for overseeing the development, coordination, and implementation of Phase 1 clinical research studies at the organization's facilities. Individuals in these roles collaborate closely with the principal investigator, serve as liaisons between research subjects, client teams, investigators, and clinic operations teams, and meticulously plan logistics and resource usage. These roles require tracking study progress in alignment with project milestones, client deliverables, and budget, while ensuring compliance with applicable regulations globally and by region.Impact and ContributionIndividual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Individual contributor with developing subject matter expertise and responsibility for processes. In-depth knowledge and skills within a professional discipline, understanding the impact of work on related areas. May be responsible for entire projects or processes within area of responsibility.</div>

Clinical Operations Manager - Systems&Process Improvement - FSP - Istanbul

ICON plc

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

Manager Clinical Operations

TYG Consultant's

<p><b>Clinical Data Manager</b></p><p><b>100 percent onsite-Location: Maple Grove, MN</b></p><p><b>Hours: 8:00am-4:00 PM</b></p><p><b>Duration: This is a 6-month contract with potential to extend highly likely</b></p><p><b>Main purpose of role</b></p><p><b>Summarize the main purpose of the role.</b></p><p>The Clinical Data Manager is responsible for managing the development, documentation, and execution of risk-based quality management systems, as described in the risk assessment, data management plan, and site and central monitoring plans.</p><p>As the customer-face of Data Review and its primary liaison with the therapy group, the Clinical Data Manager's therapy-specific knowledge ensures alignment to customer definitions of criticality, and informs review and analysis of study data.</p><p><b>Main responsibilities</b></p><ul><li>Identification of study specific risks to study conduct and human subject safety; analysis of risks; development and implementation of mitigation strategies.</li><li>Review of study data to detect anticipated and unanticipated issues related to trial data completeness and quality.</li><li>Facilitate multi-stakeholder discussions to review findings, evaluate impact and develop action plans for correction and continued monitoring.</li><li>Conduct Central Monitoring activities, as described in Central Monitoring Plan.</li><li>Direct all data cleaning activity related to assigned studies.</li></ul><p><b>Qualifications</b></p><ul><li>Bachelors Degree (&plusmn; 16 years) Biology, Health Sciences, Mathematics, Computer Science, or equivalent.</li></ul><p><b>Experience/Background</b></p><ul><li>Minimum 3 years</li></ul><p><b>Experience Details</b></p><ul><li>3 years in clinical operations or healthcare related field.</li><li>Education and work experience in project management, life sciences and/or technical field.</li><li>Knowledge of data collection best practices for clinical trials.</li><li>Knowledge of global clinical operations.</li><li>Experience in consultative role, with Subject Matter Expertise, and effectively influencing a team decision to the desired outcome.</li><li>Proficient at the identification of risks in a process, evaluation of likelihood and impact, and the development of effective mitigation and monitoring strategies that are imperfect yet meet the business need.</li><li>Proficient in the translation of clinical trial requirements to the technical specifications required for effective data collection.</li><li>Skilled at making inferences and connections based on limited information, clearly describing the knowns, unknowns, and alternative explanations.</li><li>Intermediate project management skills; developing a multifaceted plan with complex dependencies and holding peers accountable to adherence to the plan while maintaining positive and collaborative relationships.</li><li>Intermediate therapy specific knowledge of anatomy, physiology, pathophysiology, therapy and device.</li></ul><p><b>Licenses and Certifications</b></p><ul><li>None required; Certified Clinical Data Manager (CCDM) or equivalent nice to have.</li></ul><p>Job Type: Contract</p><p>Pay: $42.00 - $44.00 per hour</p><p>Expected hours: 40 per week</p><p>Benefits:</p><ul><li>Health insurance</li></ul><p>Education:</p><ul><li>Bachelor's (Preferred)</li></ul><p>Experience:</p><ul><li>clinical data: 3 years (Preferred)</li><li>EDC (Electronic Data Capture): 3 years (Preferred)</li><li>central monitoring or risk-based monitoring: 3 years (Preferred)</li><li>pharma, medical device, CRO or healthcare industry: 3 years (Preferred)</li><li>overseeing clinical trial data: 3 years (Preferred)</li></ul><p>Ability to Commute:</p><ul><li>Maple Grove, MN 55311 (Preferred)</li></ul><p>Work Location: In person</p>

Clinical Data Manager (EDC/Clinical Operations/Central Monitoring) (Pharma/Healthcare)

Triveni Bio

<div><div>COMPANY INTRODUCTION</div><div></div><div><br>
Triveni Bio is breaking new ground in the identification of novel disease targets &ndash; working at the convergence of human genetics, best-in-class antibody design, and precision medicine. We are pioneering a Mendelian genetics-informed precision medicine approach to develop functional antibodies for the treatment of immunological and inflammatory (I&amp;I) disorders. Our lead antibody program (TRIV-509) targets kallikreins 5 and 7 (KLK5/7) to directly impact skin barrier function, inflammation, and itch &ndash; providing a meaningful and much needed potential treatment option for patients with atopic dermatitis and other barrier disorders. In all the work we do, we adhere to our core values: patient impact, bold and rigorous science, open collaboration, kindness &amp; respect.</div><div></div><div><br>
We are seeking a proactive and detail-oriented Translational Medicine Operations Manager to join our dynamic and lean team. This role is pivotal in ensuring the seamless execution of translational strategies that bridge discovery and clinical development. You&rsquo;ll be instrumental in coordinating scientific operations, managing timelines, and supporting cross-functional initiatives that accelerate and support our clinical programs. On a day-to-day basis, you will work closely with Clinical Pharmacology, Clinical Operations and Clinical Development. This unique opportunity offers you to take ownership of translational operational initiatives across multiple clinical programs.</div><div>
</div><div><b>
RESPONSIBILITIES
</b></div><div>
</div><ul><li> Lead Translational Medicine and Clinical Pharmacology operational strategy across multiple programs, owning timelines and vendor relationships</li><li> In conjunction with Clinical Operations, oversee operational aspects of translational medicine and clinical pharmacology programs, including study planning, vendor management and sample logistics to ensure high quality bioanalytical and biomarker analysis for multiple clinical trials.
</li><li> Develop and maintain strong working relationships with internal and external stakeholders (cross-functional team members, CROs, external experts, and investigators), ensuring timely delivery of biomarker and clinical pharmacology data.</li><li> Manage/contribute to management of external vendors (e.g. central labs, biorepositories, assay providers, etc.) and development of laboratory manuals and kit design including sample collection, processing, storage and shipment requirements.
</li><li> Oversee sample life-cycle management, including collection, tracking, shipment, data analysis and transfer and addressing related issues.
</li><li> Develop, maintain and optimize workflows, SOPs and project tracking tools to enhance team efficiency</li><li> Other duties as assigned.</li></ul><div></div><div><br>
</div><div><b>
EXPERIENCE &amp; QUALIFICATIONS</b></div><div>
</div><ul><li> B.S in life sciences or a related discipline with 5+ years of experience in clinical operations, translational medicine or biomarker program support</li><li> Familiarity with clinical trial processes, sample management and vendor coordination is required</li><li> Strong organizational skills and demonstrated ability to solve problems with innovative solutions</li><li> Proven ability to collaborate across cross-functionally</li></ul>
<div>The posted range reflects the current reasonable and good faith estimate of the base salary for this full-time position. Actual compensation will be based on a variety of factors including, but not limited to, relevant skills and experience, educational background and certifications, performance and qualifications, market demand for the role, geographic location and other organizational needs. This role also offers a competitive target bonus, equity, and a comprehensive benefits package.</div><div>
</div><div>
We are committed to fair pay practices, and we regularly review our compensation programs to ensure they are competitive, equitable, and aligned with our values. Please note that the advertised pay range is not a guarantee or promise of a specific wage.</div><div></div><div><br>
Triveni Bio, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Official Triveni Bio applications will always be submitted through Lever, our ATS. Any applications that take you to other platforms could be fraudulent. We do not use text or chat applications to conduct interviews or make job offers. Official Triveni Bio correspondence will always be conducted from email addresses ending in @triveni.bio. Please disregard any other communication that does not originate from this domain name. If you receive any suspicious requests or communications, please verify their authenticity before responding.</div></div>

Translational Medicine Operations Manager

Acentra Health

<div>Company Overview:
<div>
Acentra Health exists to empower better health outcomes through technology, services, and clinical expertise. Our mission is to innovate health solutions that deliver maximum value and impact.</div><div></div><div><br>
Lead the Way is our rallying cry at Acentra Health. Think of it as an open invitation to embrace the mission of the company; to actively engage in problem-solving; and to take ownership of your work every day. Acentra Health offers you unparalleled opportunities. In fact, you have all you need to take charge of your career and accelerate better outcomes &ndash; making this a great time to join our team of passionate individuals dedicated to being a vital partner for health solutions in the public sector.</div>
Job Summary and Responsibilities:
<p><b>
Acentra Health is looking for a Manager of Clinical Review to join our growing team.</b></p><div><b><br>
Job Summary:</b></div><ul><li>
The Manager of Clinical Review is responsible for overseeing the clinical operations of the organization, ensuring that the highest quality of care is provided to patients while meeting compliance and regulatory requirements.</li></ul><div><b><br>
Responsibilities:</b></div><ul><li>
Monitor quality of care and compliance with policies and regulations.</li><li>
Coordinate with healthcare professionals to ensure seamless care delivery.</li><li>
Provide training and support to clinical staff to enhance their skills and performance.</li><li>
Evaluate staff performance and provide feedback.</li><li>
Manage budgets and resources effectively to optimize clinical operations.</li><li>
Participate in strategic planning for clinical services.</li><li>
Conduct regular staff meetings to discuss operational issues and improvements.</li><li>
Read, understand, and adhere to all corporate policies including policies related to HIPAA and its Privacy and Security Rules.</li></ul>
Qualifications:
<p><b>
Required Qualifications</b></p><ul><li>
Active unrestricted RN license required.</li><li>
Minimum three years of clinical management experience required.</li><li>
Strong knowledge of regulatory standards and healthcare laws.</li></ul><p><b>
Preferred Qualifications</b></p><ul><li>
Bachelor's degree in nursing or healthcare administration preferred.</li><li>
Excellent leadership and interpersonal skills.</li><li>
Ability to manage multiple priorities effectively.</li><li>
Strong communication and problem-solving abilities.</li></ul><div><b>
Why us?</b></div><div></div><div><br>
We are a team of experienced and caring leaders, clinicians, pioneering technologists, and industry professionals who come together to redefine expectations for the healthcare industry. State and federal healthcare agencies, providers, and employers turn to us as their vital partner to ensure better healthcare and improve health outcomes.</div><div></div><div><b><br>
We do this through our people.</b></div><div></div><div><br>
You will have meaningful work that genuinely improves people's lives across the country. We are a company that cares about our employees, and we give you the tools and encouragement you need to achieve the finest work of your career.</div><div></div><div><b><br>
Benefits</b></div><div></div><div><br>
Benefits are a key component of your rewards package. Our benefits are designed to provide you with additional protection, security, and support for both your career and your life away from work. Our benefits include comprehensive health plans, paid time off, retirement savings, corporate wellness, educational assistance, corporate discounts, and more.</div><div></div><div><b><br>
Thank You!</b></div><div></div><div><br>
We know your time is valuable and we thank you for applying for this position. Due to the high volume of applicants, only those who are chosen to advance in our interview process will be contacted. We sincerely appreciate your interest in Acentra Health and invite you to apply to future openings that may be of interest. Best of luck in your search!</div><div></div><div><br>
~ The Acentra Health Talent Acquisition Team</div><div></div><div><br>
Visit us at https://careers.acentra.com/jobs</div><div></div><div><b><br>
EEO AA M/F/Vet/Disability</b></div><div></div><div><br>
Acentra Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, status as a protected veteran or any other status protected by applicable Federal, State or Local law.</div><div></div><div><b><br>
Compensation</b></div><div></div><div><br>
The pay range for this position is listed below.</div><div></div><div><br>
&ldquo;Based on our compensation philosophy, an applicant&rsquo;s position placement in the pay range will depend on various considerations, such as years of applicable experience and skill level.&rdquo;</div>
Pay Range: USD $95,040.00 - USD $118,800.00 /Yr.</div>

Manager of Clinical Review (Remote)

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

Clove Dental

<p><b>Job Title:</b> Clinic Head</p><p><b>Location:</b> Challagatta &amp; Srinivasouram, Bangalore<br/><b>Experience Required:</b> 3&ndash;5 years<br/><b>Languages:</b> English, Hindi (Mandatory), Kannada (Preferred)</p><p><b>About the Role:</b></p><p>We are looking for an experienced and dedicated <b>Clinic Head</b> to lead and manage daily operations of our clinics in Challagatta and Srinivasouram. This role demands strong clinical expertise, leadership skills, and the ability to ensure smooth functioning of the clinic while maintaining the highest standards of patient care and operational efficiency.</p><p><b>Key Responsibilities : Clinical Responsibilities:</b></p><ul><li>Perform and oversee all clinical treatments as per standard protocols.</li><li>Ensure patient consultations, diagnostics, and procedures are conducted with high clinical quality and empathy.</li><li>Maintain accurate patient records and ensure adherence to medical compliance and safety standards.</li></ul><p><b>Operational Management:</b></p><ul><li>Supervise and manage day-to-day clinic operations, including staff coordination, scheduling, and resource allocation.</li><li>Monitor inventory, ensure availability of medical supplies, and maintain clinic hygiene and safety.</li><li>Drive clinic performance metrics including patient satisfaction, operational efficiency, and service delivery.</li></ul><p><b>Team Leadership:</b></p><ul><li>Lead and mentor the clinic team including doctors, nurses, technicians, and front-desk staff.</li><li>Conduct regular team meetings, training sessions, and performance reviews.</li><li>Foster a positive and professional work environment.</li></ul><p><b>Customer Service:</b></p><ul><li>Ensure excellent patient experience from entry to exit.</li><li>Address patient feedback and resolve complaints promptly and professionally.</li></ul><p><b>Qualifications &amp; Skills:</b></p><ul><li>Bachelor&rsquo;s degree in Medicine or relevant clinical field (BAMS/BHMS/BDS/MBBS preferred).</li><li>3&ndash;5 years of experience in clinical practice with team or clinic management exposure.</li><li>Strong leadership and interpersonal skills.</li><li>Proficient in English and Hindi; Kannada proficiency is a strong advantage.</li><li>Excellent organizational and problem-solving abilities.</li></ul><p><b>What We Offer:</b></p><ul><li>Competitive salary and performance-based incentives.</li><li>Immense learning opportunities under the guidance of <b>seasoned dentists</b>.</li><li>Exposure to a variety of clinical cases and modern treatment protocols.</li><li>Opportunity to lead and grow within a high-potential, patient-centric clinic environment.</li><li>Supportive and collaborative work culture focused on continuous development and clinical excellence.</li></ul><p>Job Type: Full-time</p><p>Pay: &#8377;30,000.00 - &#8377;50,000.00 per month</p><p>Application Question(s):</p><ul><li>How many years of clinical experience do you have? </li></ul><p>Work Location: In person</p>

General Dentist

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