clinical study manager

Parexel

<div><p><b>Job Summary:</b></p><p>
The Digital Medicine and Translational Imaging Study Manager will play a critical role in ensuring the quality of digital medicine data collected across multiple portfolio studies. This position supports the Digital Medicine and Translational Imaging group's mission to develop and implement novel technologies, with a specific focus on digital health technologies that objectively, remotely, and continuously assess patients over time using novel digital endpoints.</p><p></p><h2 class="jobSectionHeader"><b>
Key Responsibilities:</b></h2><h3 class="jobSectionHeader"><b>
Data Quality Monitoring</b></h3><ul><li>
Review and monitor multiple dashboards to ensure data is being collected as expected</li><li>
Verify participant compliance with device wear periods as specified in protocols</li><li>
Monitor data transmission and device performance (battery/memory capacity)</li><li>
Identify and follow up on necessary actions or issues</li></ul><p></p><h3 class="jobSectionHeader"><b>
Operational Support</b></h3><ul><li>
Review participant and site guides for accuracy and completeness</li><li>
Attend meetings with vendors and study staff to ensure proper site start-up and conduct</li><li>
Address troubleshooting or site-based issues related to digital medicine components</li><li>
Conduct participant follow-ups as needed</li></ul><p></p><h3 class="jobSectionHeader"><b>
Process Improvement</b></h3><ul><li>
Identify opportunities and trends to enhance standardization and efficiency of operational activities</li><li>
Collate lessons learned, frequently asked questions, and study-specific exceptions</li><li>
Contribute to the continuous improvement of digital medicine assessment processes</li></ul><p></p><h2 class="jobSectionHeader"><b>
Qualifications:</b></h2><h3 class="jobSectionHeader"><b>
Knowledge and Experience</b></h3><ul><li>
Experience with trial management of Medical Device and/or Wearable Device studies is required</li><li>
Exceptional knowledge of study management processes and deliverables</li><li>
Good knowledge in understanding the responsibilities beyond their function to ensure goals are met for the study</li><li>
Maintains expertise within the assigned therapeutic area and study to set the appropriate strategy, identify risks and to drive operational deliverables</li><li>
Working knowledge of Good Clinical Practices (GCPs), monitoring, clinical and regulatory operations</li><li>
Experience in clinical research or digital health technology implementation</li><li>
Strong attention to detail and data monitoring skills</li><li>
Excellent communication and stakeholder management abilities</li><li>
Problem-solving mindset with ability to identify trends and improvement opportunities</li></ul><h3 class="jobSectionHeader"><b>
Education</b></h3><ul><li>
Bachelor's of Science or Bachelor's of Arts degree with a minimum 7 years of relevant operational clinical trial experience required</li><li>
Master's of Science or Master's of Business Administration degree with a minimum 6 years of relevant operational clinical trial experience required</li><li>
A scientific or technical degree is preferred along with extensive knowledge of clinical trial methodology</li></ul><p></p><p>
#LI-LG4</p><br>
#LI-REMOTE</div>

Clinical Study Manager, Digital Medicine & Translational Imaging - 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

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

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

Gadgeon Medical Systems Pvt Ltd.

<p><b>About Webcardio </b></p><p>Webcardio is a leading provider of innovative cardiac monitoring solutions, offering Doctors and patients real-time, remote cardiac diagnostics through advanced wearable ECG technology. Our mission is to improve cardiac care delivery using AI driven insights and seamless technology.</p><p><b>Role Overview</b></p><p>The Medical Affairs Manager will lead and oversee clinical and medical activities, ensuring high-quality, compliant, and evidence-based clinical research and communication. The role involves managing clinical studies, regulatory compliance, cross-functional collaboration, and scientific communication to support product development, marketing, and sales initiatives.</p><p><b>Key Responsibilities:</b></p><p><b>1. Clinical Study Management</b></p><ul><li>Design, plan, and manage clinical trials, including Real-World Evidence (RWE) studies.</li><li>Ensure adherence to Good Clinical Practices (GCP) and ethical guidelines.</li><li>Collaborate with investigators, Key Opinion Leaders (KOLs), and research sites.</li><li>Collect, analyse, and interpret post-marketing clinical data.</li><li>Conduct retrospective analyses of WebCardio data.</li><li>Lead prospective clinical trials, including protocol design, medical writing, and data analysis to ensure smooth execution.</li></ul><p><b>2. Regulatory &amp; Compliance Oversight</b></p><ul><li>Ensure compliance with regulatory requirements (e.g., CDSCO) and internal standards.</li><li>Prepare clinical documentation for regulatory submissions and approvals.</li><li>Monitor evolving clinical and regulatory standards to ensure ongoing compliance.</li></ul><p><b>3. Cross-Functional Collaboration</b></p><ul><li>Partner with marketing, sales, and other functions to provide clinical insights that enhance strategy and product development.</li><li>Support sales teams in addressing clinical objections with evidence-based information.</li><li>Collaborate with KOLs to gather insights for ongoing and future projects.</li><li>Travel as required to support studies and stakeholder engagement.</li></ul><p><b>4. Scientific &amp; Medical Communication</b></p><ul><li>Prepare clinical study reports, white papers, and publications.</li><li>Present clinical data at conferences, webinars, and to internal and external stakeholders.</li><li>Provide scientific training to KOLs, speakers, and the sales team as required.</li></ul><p><b>Qualifications &amp; Experience:</b></p><ul><li>Degree in Medicine, Pharmacy, or Life Sciences (MBBS,PHD,PharmD, or equivalent).</li><li>Proven experience in clinical study management, medical affairs, or regulatory roles in healthcare/medical device/biotech sectors.</li><li>Strong knowledge of GCP, clinical research methodology, and regulatory requirements.</li><li>Excellent communication, collaboration, and analytical skills.</li><li><b>Place of work- Delhi/NCR (WFH)</b></li><li>Min 3+ Years of experience</li><li>Travel- 25% of time and depends on study requirements.</li></ul><p>Job Types: Full-time, Permanent</p><p>Pay: &#8377;800,000.00 - &#8377;1,200,000.00 per year</p><p>Application Question(s):</p><ul><li>Current CTC</li><li>Expected CTC</li></ul><p>Education:</p><ul><li>Bachelor's (Required)</li></ul><p>Experience:</p><ul><li>clinical study management: 2 years (Required)</li></ul><p>Location:</p><ul><li>Delhi, Delhi (Required)</li></ul><p>Willingness to travel:</p><ul><li>25% (Required)</li></ul><p>Work Location: Remote</p>

Medical Affairs Manager

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

Ray-CRO

<p>Clinical Study Coordinators are tasked with administering clinical trials. Their primary responsibilities include managing clinical trials and collecting data, informing participants about study objectives, and administering questionnaires.</p><p>KEY RESPONSIBILITIES AND TASKS</p><p>&middot; Adhere to Good Clinical Practices and the study protocols</p><p>&middot; Ensure scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials</p><p>&middot; Provide patient with written communication of their participation (i.e. copy of the signed informed consent)</p><p>&middot; Meet with patient for each visit and maintain accessibility to discuss any questions/concerns regarding the study</p><p>&middot; Schedule all patient research visits and procedures consistent with protocol requirements</p><p>&middot; Complete and maintain case report forms, and review them against the patient&rsquo;s medical record for completeness and accuracy</p><p>&middot; Administer questionnaires/diaries/other patient material per protocol</p><p>&middot; Ensure that non-serious and serious adverse events are properly documented and reported</p><p>&middot; Manage communication with study vendors as needed</p><p>&middot; Ensure the filing and maintenance of all study documents</p><p>&middot; Schedule monitor visits and set up for monitoring visits prior to monitor&rsquo;s arrival</p><p>&middot; Act as a liaison between site staff and different departments</p><p>&middot; Saudi residency is required</p><p>. Minimum Experience 1 year .</p><p>Job Type:</p><p>Full-time</p><p>Job Type: Full-time</p><p>Job Type: Full-time</p>

Clinical Study Coordinator

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