clinical trial manager

<div><p>Job Description</p><p></p><p>
Are you passionate about driving high‑quality clinical trials and building strong partnerships with investigators? Do you thrive in a role that combines <b>end‑to‑end study ownership, cross‑functional leadership, and strategic impact</b>?</p><p>
We are looking for a <b>Clinical Research Manager (CRM)</b> to lead the operational delivery of clinical trials at country (and potentially cluster) level, ensuring excellence in execution, compliance, and stakeholder collaboration.</p><p></p><h2 class="jobSectionHeader"><b>
Key Responsibilities</b></h2><ul><li><p>
Serve as the <b>main point of contact</b> for assigned protocols, representing country operations within global Clinical Trial Teams</p></li><li><p>
Lead <b>end‑to‑end project management</b> of clinical trials&mdash;from feasibility and site selection through execution and close‑out</p></li><li><p>
Ensure <b>compliance with ICH/GCP, local regulations, internal policies, and safety reporting requirements</b></p></li><li><p>
Drive study performance by proactively planning, tracking, and resolving risks related to timelines, quality, and recruitment</p></li><li><p>
Lead and coordinate <b>local study teams</b>, acting as protocol expert and supporting CRAs and other country roles</p></li><li><p>
Review monitoring visit reports, identify performance gaps, and escalate issues as needed</p></li><li><p>
Conduct <b>quality control visits</b> when required</p></li><li><p>
Develop and execute <b>local risk management plans</b> for assigned studies</p></li><li><p>
Ensure accurate and timely use of <b>CTMS, eTMF, and other key systems</b></p></li><li><p>
Build strong, trust‑based relationships with <b>investigators, vendors, and external partners</b></p></li><li><p>
Share best practices across studies, countries, and clusters</p></li><li><p>
Contribute to <b>local and regional clinical operations strategy</b> in collaboration with internal stakeholders</p></li></ul><h3 class="jobSectionHeader"><b>
Experience &amp; Education</b></h3><ul><li><p>
Bachelor&rsquo;s degree in Science or equivalent (advanced degree preferred)</p></li><li><p><b>
5&ndash;6 years of experience in clinical research</b></p></li><li><p>
CRA experience is an advantage</p></li></ul><h3 class="jobSectionHeader"><b>
Core Skills</b></h3><ul><li><p>
Strong <b>project and site management</b> expertise</p></li><li><p>
Solid understanding of <b>clinical trial planning, execution, and performance metrics</b></p></li><li><p>
Excellent knowledge of the <b>local regulatory environment</b></p></li><li><p>
Ability to manage multiple studies and priorities simultaneously</p></li><li><p>
Fluent in <b>English and local language (Arabic)</b>, with strong written and verbal communication skills</p></li></ul><h3 class="jobSectionHeader"><b>
Leadership &amp; Behaviors</b></h3><ul><li><p>
Proven ability to <b>lead without direct authority</b> and influence cross‑functional teams</p></li><li><p>
Strong problem‑solving and risk‑mitigation mindset</p></li><li><p>
Skilled in navigating complex situations such as recruitment challenges, compliance issues, and resource constraints</p></li><li><p>
Collaborative, culturally aware, and effective in <b>remote/virtual environments</b></p></li><li><p>
Professional, diplomatic, and confident when engaging with investigators and stakeholders</p></li></ul><p></p><p><b>
Required Skills:
</b></p>Clinical Data Management, Clinical Research, Clinical Site Management, Clinical Trial Management Processes, Clinical Trials Operations, Good Clinical Practice (GCP), Planning, Project Management, Quality Management, Risk Management, Stakeholder Engagement<p></p><p><b>
Preferred Skills:
</b></p><p></p><p>Current Employees apply HERE</p><p></p><p>
Current Contingent Workers apply HERE</p><p></p><p><b>
Search Firm Representatives Please Read Carefully</b><br>
Merck &amp; Co., Inc., Rahway, NJ, USA, also known as Merck Sharp &amp; Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.</p><p></p><p><b>
Employee Status:
</b></p>Regular<p></p><p><b>
Relocation:</b></p><p></p><p><b>
VISA Sponsorship:</b></p><p></p><p><b>
Travel Requirements:</b></p><p></p><p><b>
Flexible Work Arrangements:</b></p>
Hybrid<p></p><p><b>
Shift:</b></p><p></p><p><b>
Valid Driving License:</b></p><p></p><p><b>
Hazardous Material(s):</b></p><p></p><p><b>
Job Posting End Date:</b></p>
04/27/2026<ul><li><b>A job posting is effective until 11:59:59PM on the day </b><b>BEFORE</b><b> the listed job posting end date. Please ensure you apply to a job posting no later than the day </b><b>BEFORE</b><b> the job posting end date.<br>
</b></li></ul><br>
<p><b>Requisition ID:</b>R392298</p></div>

Clinical Research Manager

Solace Clinical Research

<p><b>Job Summary</b><br/>We are seeking a dynamic and highly organized Clinical Research Site Manager to lead and oversee the daily operations of our clinical trial site. In this pivotal role, you will coordinate all aspects of clinical trials, ensuring compliance with regulatory standards, maintaining high-quality documentation, and fostering a patient-centered environment. Your leadership will drive the successful execution of research studies, facilitate effective communication among team members, and uphold the integrity of data collection and management. This position offers an exciting opportunity to contribute to groundbreaking medical research while supporting the advancement of healthcare solutions.</p><p><b>Responsibilities</b></p><ul><li>Supervise and coordinate the activities of clinical research staff, including nurses, coordinators, and laboratory personnel, ensuring seamless trial operations</li><li>Manage patient recruitment, screening, enrollment, and ongoing monitoring to ensure adherence to study protocols and regulatory requirements</li><li>Oversee data collection processes, review source documents for accuracy, and ensure proper documentation in accordance with ICH GCP standards and FDA regulations</li><li>Maintain compliance with HIPAA regulations and ensure confidentiality of patient information throughout all trial activities</li><li>Review clinical documentation such as case report forms (CRFs), laboratory results, vital signs, and adverse event reports for completeness and accuracy</li><li>Monitor clinical laboratory procedures including blood sampling, phlebotomy, and specimen handling to ensure quality standards are met</li><li>Utilize electronic medical record (EMR) systems and statistical software for data management, analysis, and reporting purposes</li><li>Ensure adherence to CDISC standards for data formatting and reporting in clinical trials</li><li>Conduct regular site audits to verify compliance with protocol requirements and regulatory guidelines</li><li>Facilitate training sessions on Good Clinical Practice (GCP), FDA regulations, and study-specific procedures for staff members</li></ul><p><b>Qualifications</b></p><ul><li>Proven supervising experience in a clinical research environment or healthcare setting</li><li>Strong knowledge of clinical trials management, including patient monitoring and data collection techniques</li><li>Familiarity with medical terminology, clinical laboratory procedures, and blood sampling techniques</li><li>Experience with EMR systems, statistical software, and data management tools used in clinical research</li><li>In-depth understanding of FDA regulations, ICH GCP guidelines, HIPAA compliance, and CDISC standards</li><li>Certification in Good Clinical Practice (GCP) from a recognized issuer for CA or equivalent is required; additional certifications such as an ICH GCP certificate are preferred</li><li>Background in nursing or clinical laboratory work is advantageous</li><li>Excellent analysis skills with attention to detail for reviewing documentation and ensuring protocol adherence</li><li>Ability to lead teams effectively while maintaining a positive work environment</li></ul><p>Join us in advancing innovative healthcare solutions by managing impactful clinical research studies. Your expertise will help shape the future of medicine while supporting a collaborative team dedicated to excellence in clinical development.</p><p>Pay: $20.00 - $38.00 per hour</p><p>Benefits:</p><ul><li>401(k)</li><li>Health insurance</li><li>Paid time off</li></ul><p>Work Location: In person</p>

Clinical Research Site Manager

Medpace

<div>
 <strong>
  Clinical Research Coordinators wanted at Medpace! Become a CRA and join our growing team!
  <br/>
  <br/>
 </strong>
 This is an exciting opportunity for clinical research professionals with at least one year of Clinical Research Coordinator experience to fill Clinical Research Associate (CRA) openings with Medpace. Through our
 <em>
  PACE&reg;
 </em>
 Training Program, you will receive the training needed to become a fully functional CRA with the opportunity to work home-based. You will also have the opportunity to earn a generous travel bonus in addition to a competitive salary.
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 <br/>
 <strong>
  WE OFFER THE FOLLOWING
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Competitive travel bonus;
  </li>
  <li>
   Equity/Stock Option program;
  </li>
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   Training completion and retention bonus
  </li>
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   Annual merit increases;
  </li>
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   401K matching;
  </li>
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   The opportunity to work from home;
  </li>
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   Flexible work hours across days within a week;
  </li>
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   Retain airline reward miles and hotel reward points;
  </li>
  <li>
   Home office furniture allowance, laptop, mobile phone with hotspot for internet access anywhere;
  </li>
  <li>
   In-house travel agents, reimbursement for airline club, and TSA pre-check;
  </li>
  <li>
   Opportunity for leadership positions &ndash; Lead CRA, CRA Manager, Clinical Trial Manager, Training and Development Manager, and many more;
  </li>
  <li>
   CRA training program (PACE&reg;);
  </li>
  <li>
   Ongoing therapeutic training by our in-house physicians who are medical and regulatory experts;
  </li>
  <li>
   In-house administrative support for all levels of CRAs; and
  </li>
  <li>
   Opportunities to work with international team of CRAs.
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  </li>
 </ul>
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  Responsibilities
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 </strong>
 <ul>
  <li>
   Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol;
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   Communication with the medical site staff including coordinators, clinical research physicians, and their site staff;
  </li>
  <li>
   Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
  </li>
  <li>
   Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements;
  </li>
  <li>
   On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward;
  </li>
  <li>
   Verification that the investigator is enrolling only eligible subjects;
  </li>
  <li>
   Regulatory document review;
  </li>
  <li>
   Medical device and/or investigational product/drug accountability and inventory;
  </li>
  <li>
   Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
  </li>
  <li>
   Assess the clinical research site&rsquo;s patient recruitment and retention success and offering suggestions for improvement; and
  </li>
  <li>
   Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
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   <br/>
  </li>
 </ul>
 <strong>
  Qualifications
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  <br/>
 </strong>
 <ul>
  <li>
   Must have a minimum of a Bachelor&rsquo;s degree in a health or science related field;
  </li>
  <li>
   Experience as a Clinical Research Coordinator (minimum 1 year);
  </li>
  <li>
   Ability to travel 60-70% to locations nationwide is required; some visits may be conducted remotely
  </li>
  <li>
   Must maintain a valid driver&rsquo;s license and the ability to drive to monitoring sites;
  </li>
  <li>
   Proficient knowledge of Microsoft&reg; Office;
  </li>
  <li>
   Strong communication and presentation skills; and
  </li>
  <li>
   Must be detail-oriented and efficient in time management.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  <br/>
  <br/>
 </strong>
 <strong>
  Medpace Overview
  <br/>
  <br/>
 </strong>
 Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.
 <br/>
 <br/>
 <strong>
  Why Medpace?
  <br/>
  <br/>
 </strong>
 People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
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 The work we&rsquo;ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
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 <strong>
  Medpace Perks
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Flexible work environment
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   Competitive PTO packages &ndash; starting at 20+ days
  </li>
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   Company-sponsored employee appreciation events
  </li>
  <li>
   Employee health and wellness initiatives
  </li>
  <li>
   Competitive compensation and benefits package
  </li>
  <li>
   Structured career paths with opportunities for professional growth
  </li>
  <li>
   Discounts for local businesses
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Awards
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Named a Top Workplace in 2024 by The Cincinnati Enquirer
  </li>
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   Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
  </li>
  <li>
   Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  What To Expect Next
  <br/>
  <br/>
 </strong>
 A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
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</div>


Clinical Research Coordinator to Home-Based CRA (Clinical Research Associate)

Cardiovascular Associates of America

<div><p><b>Job Title:</b> Clinical Research Coordinator<br>
<b>Location:</b> On-site position in Davenport, Iowa</p><p></p><h3 class="jobSectionHeader"><b>
About CVAUSA:</b></h3><p>
Cardiovascular Associates of America (CVAUSA) is a rapidly growing leader in cardiovascular care, committed to advancing medical research and improving patient outcomes. As part of our expansion, we are increasing our clinical trial operations and looking for dynamic, results-driven professionals to join our team.</p><p>
At CVAUSA, we are focused on innovation and excellence in cardiovascular research, and we believe the best results come from individuals who are passionate about making a difference.</p><p></p><p>
The Research Coordinator will be responsible for leading the growth and development of the research program while also working with clinic staff on existing and new clinical trials. As part of CVAUSA&rsquo;s national network, the Clinical Research Coordinator will have the opportunity to collaborate with teams across the country, making an impact on cardiovascular care both locally and nationwide.</p><p></p><h3 class="jobSectionHeader"><b>
Position Overview:</b></h3><p>
As a Clinical Research Coordinator, you will play a key role in managing and overseeing all aspects of clinical trials and site operations. You will have the opportunity to take ownership of your projects, driving them forward with innovation, efficiency, and excellence. This is a fantastic opportunity for an ambitious, goal-oriented individual who thrives in an independent, fast-paced environment.</p><p></p><h3 class="jobSectionHeader"><b>
Key Responsibilities:</b></h3><p><b>
Clinical Trial Management:</b><br>
Oversee all aspects of clinical trials, including patient recruitment, screening, and enrollment. Ensure that protocols are followed meticulously.</p><p><b>
Site Operations:</b><br>
Handle day-to-day site management, ensuring that all activities comply with regulatory requirements and study protocols.</p><p><b>
Data Management:</b><br>
Collect, verify, and manage clinical trial data, ensuring it is accurate and complete.</p><p><b>
Communication &amp; Reporting:</b><br>
Act as the primary point of contact for study sponsors, participants, and other stakeholders. Provide regular updates and progress reports.</p><p><b>
Regulatory Compliance:</b><br>
Ensure all documentation, including regulatory submissions and patient records, are kept up-to-date and in compliance with ethical and legal standards.</p><p><b>
Problem Solving &amp; Innovation:</b><br>
Identify areas for process improvement and implement solutions to drive efficiency and enhance trial operations.</p><p></p><h3 class="jobSectionHeader"><b>
What We&rsquo;re Looking For:</b></h3><p><b>
Goal-Driven &amp; Independent:</b><br>
You thrive in an autonomous work environment and take full ownership of your responsibilities.</p><p><b>
Innovative &amp; Results-Driven:</b><br>
You are eager to contribute to CVAUSA&rsquo;s growth and bring effective solutions to the table.</p><p><b>
Detail-Oriented &amp; Highly Organized:</b><br>
You have the ability to manage multiple tasks and deadlines without sacrificing quality.</p><p><b>
Strong Communicator:</b><br>
You can effectively communicate with stakeholders at all levels, including sponsors, site staff, and participants.</p><p></p><h3 class="jobSectionHeader"><b>
Experience &amp; Qualifications:</b></h3><ul><li>
Clinical experience in cardiovascular medicine in a licensed or clinical support role (e.g., RN, technologist, medical assistant)</li><li>
Bachelor&rsquo;s degree in a relevant field (e.g., life sciences, healthcare, or clinical research)</li><li>
Experience managing clinical trials, leading enrollment across multiple studies, and supporting research program development</li><li>
Strong organizational and time management skills</li><li>
Clinical research certification (e.g., CCRP) is a plus</li><li>
Knowledge of GCP, ICH guidelines, and regulatory requirements</li></ul><p></p><h3 class="jobSectionHeader"><b>
Why CVAUSA?</b></h3><p>
At CVAUSA, we believe in the power of innovation and are looking for professionals eager to make an impact in cardiovascular research. As a rapidly growing organization, you will be at the forefront of cutting-edge clinical trials, contributing to improved patient outcomes.</p><p>
You will work on-site in Davenport, Iowa, leading a growing cardiovascular research program while collaborating with teams nationwide. We offer competitive compensation, flexible working hours, and a supportive, dynamic environment where your contributions are valued.</p><p>
If you are ambitious, innovative, and ready to take your career to the next level, we want to hear from you.</p><p>
</p><p>OIzXB1YfZW</p></div>

Research Coordinator

ProSciento, Inc.

<div><div><b>POSITION SUMMARY:</b></div><div></div><div><br>
The Project Manager (PM) is the lead for trials conducted within the CRO services division of ProSciento and is the main interface between ProSciento and the client. S/He will work cross-functionally as needed with Clinical Data Management (CDM), Regulatory Services, Clinical Operations (CO), Budgets and Contracts, and CRA Services to ensure that studies are conducted per protocol and client expectations, on time, within budget, and according to FDA regulations and ICH GCP. Performs duties in accordance with company&rsquo;s values, policies, and procedures.</div><div></div><ul><li><br>
This role can be hired as a level I or level II based on the candidate's working experience and background.</li></ul><div></div><div><b><br>
DUTIES AND RESPONSIBILITIES:</b></div><div></div><div><br>
<ul><li>
Performs protocol review and schedules kick-off meetings.</li><li>
Liaises and assists with Data Management, Regulatory Services, CRA Services, Pharmaceutical Services, medical writing, medical monitors, and other departments as applicable during study set-up, project management and oversight, and project close-out.</li><li>
Creates and/or approves study documentation, including informed consent templates, project plans, case report forms, and monitoring plans and reports, and oversees Clinical Study Report (CSR) development.</li><li>
Coordinates requirements for third-party vendors, including safety and specialty laboratories, biostatistics, and/or data analytics, and liaises with budgets and contracts for proposal development. Oversees vendor performance.</li><li>
Creates slides for Site Initiation Visit (SIV) and delivers or oversees the training.</li><li>
Liaises with the site(s) recruitment department(s), to ensure adequate subjects are available for screening and enrollment.</li><li>
Creates or oversees creation of additional study training materials and ensures all training is documented.</li><li>
Owns oversight of the project and requests a change order to budgets and contracts when the project scope changes.</li><li>
Plans and leads teleconferences with client and/or third-party vendors relative to project performance, status updates, and issue resolution.</li><li>
Oversees scheduling of monitoring visits and reviews Monitoring Visit Reports (MVRs).</li><li>
Coordinates dose escalation meetings and participates in data reviews.</li><li>
Builds the electronic Trial Master File (eTMF) for the project; oversees and manages the collection and filing of essential trial documents. Periodically reviews the eTMF to ensure completeness and correctness of the contents.</li><li>
Coordinates with Principal Investigator (PI)/site staff, as applicable, during study start-up and oversight activities and to ensure appropriate subject oversight, protocol adherence, and query resolution.</li><li>
Participates in client study audits, as well as internal audits conducted by quality assurance for assigned projects.</li><li>
Collects and reports study metrics (enrollment, query rates, issues, etc.).</li></ul></div><h1 class="jobSectionHeader"><b>
Additional Duties and Responsibilities for PM II</b></h1><p>
All duties defined in level one, and in addition:</p><ul><li>
Responsible for set up, conduct, and close-out of multi-center trials, as well as specialized study projects.</li><li>
Supports creation of high-level study timelines for proposals.</li><li>
Performs protocol review, site identification, feasibility, and selection, drug supply management, and site qualification, as required.</li><li>
Coordinates with CRAs to ensure Pre-Study Visits (PSVs) are conducted and reviews reports to confirm each identified site is qualified for the study.</li><li>
Ensures the success of clinical trials by overseeing study conduct at all sites involved in each study. Periodically schedules teleconferences with all CRAs participating in the trial to ensure monitoring alignment and relay project changes as applicable.</li><li>
Participates in data review to identify trends.</li><li>
Represents ProSciento and sponsor at investigator meetings.</li><li>
May mentor and/or oversee the work of other PM staff. May include supervisory activities.</li></ul><div></div><div><b><br>
JOB REQUIREMENTS / QUALIFICATIONS/EDUCATION:</b></div><div></div><div><b><br>
Level I:</b></div><br>
<div></div><ul><li>
Bachelor&rsquo;s degree in biological science or other related field and/or a combination of education and experience. Preferably two or more years of project management experience. Experience monitoring or overseeing clinical trial sites are required. Managing studies at clinical research sites is a plus.</li></ul><div></div><div><b><br>
Level II:</b></div><br>
<div></div><ul><li>
Bachelor&rsquo;s degree in biological science or other related field and/or a combination of education and experience. Preferably four or more years of project management experience, preferably in a CRO. Experience monitoring or overseeing clinical trial sites and managing service providers are required.</li></ul><div></div><div><b><br>
KNOWLEDGE, SKILLS, AND COMPETENCIES REQUIRED</b></div><div></div><div><br>
<ul><li><ul><li>
Customer Focus: Dedicated to meeting expectations and requirements of both internal and external clients. Establishes and maintains effective relationships with customers and gains their trust and respect.</li><li>
Problem Solving: Uses rigorous logic and methods to solve difficult problems with effective solutions; is excellent at analysis; looks beyond the obvious and doesn't stop at the first answers. Solid analytical skills.</li><li>
Organizing: Can marshal resources to get things done; can orchestrate multiple activities at once to accomplish a goal. Uses resources effectively and efficiently.</li><li>
Time Management: Uses his/her time effectively and efficiently; values time; concentrates his/her efforts on the more important priorities; gets more done in less time than others; can attend to a broader range of activities.</li><li>
Priority Setting: Spends his/her time and the time of others on what&rsquo;s important; quickly zeros in on the critical few and puts the trivial many aside; can quickly sense what will help or hinder accomplishing a goal; eliminates roadblocks; creates focus.</li><li>
Thorough knowledge of GCPs. Strong project management skills. Experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations. Solid financial acumen to manage project budgets.</li></ul></li></ul></div><div></div><div><b><br>
Certificates and Licenses</b></div><ul><li>
Project Management certification and/or willingness to obtain certification. MBA a plus.</li></ul><div><b>
Working Conditions and Physical Effort</b></div><ul><li>
The physical demands described here are representative of those that must be met by an employee to successfully perform essential job functions. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.</li><li>
The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job include close, distance and peripheral vision as well as depth perception and the ability to adjust focus. While performing the duties of this job the employee is regularly required to sit, talk, and hear. The employee is frequently required to stand; use hands to finger, handle, or feel and reach with hands and arms.</li></ul></div>

Project Manager II

The University of Iowa

<div><p>The Holden Comprehensive Cancer Center at the University of Iowa is seeking a Finance Manager with the Clinical Research Services team that will provide oversight for cancer clinical research finance and accounting. Proactively monitors complex accounting functions, ensuring compliance with all university, state, federal, and sponsor requirements. Negotiates budgets and acts as a resource for financial analysts in negotiating budgets with sponsors. Partners with principal investigators, clinical research staff, and administrators to increase understand of research finances and ensure transparent, compliant, and efficient management of oncology clinical research funding. Partners with leadership to support cross-departmental initiatives and organizational efforts to improve financial compliance and operational efficiency.</p><p><b>
This position is eligible for hybrid or remote work within Iowa and will require a work arrangement form to be completed upon the start of your employment. Per policy, work arrangements will be reviewed annually and must comply with the remote work program and related policies and employee travel policy when working at a remote location.</b></p><p>
Duties to include:</p><p>
Financial Operations and Oversight</p><ul><li><p>
Oversees clinical research financial workflow processes, ensuring efficiency, accuracy, and regulatory compliance.</p></li><li><p>
Continuously evaluate existing procedures for recording financial transactions to determine and implement methods to improve efficiency and accuracy.</p></li><li><p>
Acts as primary contact for issues related to industry, consortium, NCI-sponsored, and investigator-initiated budgets and accounts.</p></li><li><p>
Oversees and participates in clinical trial budget negotiations and preparation.</p></li><li><p>
Validates accuracy of monthly transactions, ensuring timely sponsor invoicing, subject reimbursements, and vendor payments.</p></li><li><p>
Participates in cross-functional committees, making recommendations and implementing change as appropriate.</p></li><li><p>
Assists in orientation and education of new staff and faculty regarding the clinical trial financial process and expectations</p></li><li><p>
Oversees the reviews of open trials, ensuring accurate financial reconciliation and implementing corrective actions for billing and compliance issue</p></li></ul><p>
Compliance &amp; Risk Management</p><ul><li><p>
Works closely with the Research Billing Compliance department of Patient Financial Services to identity opportunities to improve communication and workflows related to financial information.</p></li><li><p>
Coordinates Medicare Coverage Analyses with internal staff and external vendors and ensures alignment with the OnCore CTMS system.</p></li><li><p>
Acts as resource for internal and external audit procedures.</p></li><li><p>
Develops and implements internal controls to ensure adherence to university, state, federal, and sponsor guidelines.</p></li><li><p>
Collaborates with compliance offices (e.g., Joint Office for Compliance, Research Billing Compliance) to identify and mitigate risks.</p></li></ul><p>
Team Leadership &amp; Supervision</p><ul><li><p>
Provides administrative supervision of financial analysts, including performance management, workload assessment, and professional development.</p></li><li><p>
Establishes audit and monitoring systems to evaluate staff performance and ensure adherence to financial and compliance standards.</p></li><li><p>
Leads hiring, onboarding, and training of finance staff.</p></li><li><p>
Develops and maintains guidance documents, SOPs, and training resources for finance, regulatory, and clinical research teams.</p></li><li><p>
Designs and implements career ladder frameworks, competencies, and retention strategies in collaboration with HR to support staff growth.</p></li></ul><p>
Reporting &amp; Strategic Support</p><ul><li><p>
Oversees the preparation and analysis of monthly financial reports for HCCC leadership regarding trial revenue and expenditures</p></li><li><p>
Designs and delivers reporting tools to support principal investigators&rsquo; understanding of trial finances.</p></li><li><p>
Prepares specialized financial analyses and recommendations for leadership decision-making.</p></li><li><p>
Identifies emerging financial and compliance risks and advises leadership on process or policy changes.</p></li><li><p>
Provides financial and operational leadership for large-scale initiatives (e.g., billing system modernization, departmental integration efforts).</p></li></ul><p>
Strategic Planning &amp; Workflow Optimization</p><ul><li><p>
Provide strategic leadership in the development, implementation, and continuous improvement of post-award clinical research financial workflows to ensure efficiency, compliance, and alignment with institutional goals.</p></li><li><p>
Serve as a key stakeholder in the planning, decision-making, and cross-functional collaboration for the billing integration between the institution&rsquo;s clinical trials management and electronic medical record systems (e.g. OnCore and Epic) as it relates to clinical research finance, billing, and compliance, ensuring optimized processes and data accuracy.</p></li><li><p>
Identify opportunities to streamline financial operations and drive process improvement.</p></li></ul><p></p><p><b><br>
SUPERVISION RECEIVED:</b></p><p>
 Direct administrative supervision is exercised over all financial analysts in HCCC Clinical Research Services.</p><p>
 Functional supervision for the pre-study finance team is provided by the Regulatory and Compliance Manager for activation of trials.</p><p><b>
SUPERVISION EXERCISED:</b></p><p>
The Finance Manager reports to the Assistant Director for and collaborates extensively with the Medical Director for CPDM and the Associate Director for Clinical Research.</p><p></p><div><p><b><br>
UI Health Care Core Values (WE CARE)</b></p></div><br>
<div><div><p><b><i>
W</i></b><i>elcoming</i></p><p><i><br>
We are welcoming to the community, partners, staff, and patients utilizing the collective strength of our people.</i></p></div><div><p><b><i><br>
E</i></b><i>xcellence</i></p><p><i><br>
We achieve and deliver our personal and collective best in the pursuit of quality and accessible health care, education, and research.</i></p></div><div><p><b><i><br>
C</i></b><i>ollaboration</i></p><p><i><br>
We collaborate with health care systems, providers, and communities across Iowa and the region as well within our UI community. We believe teamwork- guided by compassion- is the best way to work.</i></p></div><div><p><b><i><br>
A</i></b><i>ccountability</i></p><p><i><br>
We behave ethically, act openly and with integrity in all that we do, taking responsibility for our actions.</i></p></div><div><p><b><i><br>
R</i></b><i>espect</i><i><br>
</i></p><p><i>We create an environment where every individual feels safe, valued, and respected, supporting the well-being and success of all members of our community.</i></p></div><div><p><b><i><br>
E</i></b><i>mpowerment</i></p><p><i><br>
We commit to fair access to research, health care, and education for our community and opportunities for personal and professional growth for our staff and learners.</i></p></div><br>
</div><p>
University of Iowa Health Care&mdash;recognized as one of the best hospitals in the United States&mdash;is Iowa's only comprehensive academic medical center and a regional referral center. Each day more than 12,000 employees, students, and volunteers work together to provide safe, quality health care and excellent service for our patients. Simply stated, our mission is: Changing Medicine. Changing Lives.&reg;</p><p>
Holden Comprehensive Cancer Center is Iowa&rsquo;s only NCI-designated comprehensive cancer center. The NCI designation recognized our cancer center, and its research scientist, physicians, and other health care professionals, for their roles in advancing cancer research that impacts on our ability to prevent, detect and treat our patients with cancer. Not just a floor, or a building, or even confined to a single college. Holden Comprehensive Cancer Center coordinates all cancer-related research, education, and patient care by faculty from 41 departments and six colleges, as well as UI Health Care and UI Children&rsquo;s Hospital.</p><p><b>
Percent of Time:</b> 100%</p><p><b>
Work Schedule: </b>Monday &ndash; Friday, Hours generally worked between 7:00am-5pm</p><p><b>
Pay Grade: </b>5B</p><p>
https://hr.uiowa.edu/pay/guide-pay-plans</p><p><b>
Benefits Highlights</b></p><ul><li><p>
Regular salaried position located in Iowa City, IA</p></li><li><p>
Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans</p></li><li><p>
For more information about Why Iowa?, click here</p></li></ul>
<div><div><b>REQUIRED QUALIFICATIONS</b></div><ul><li><div>
 Master&rsquo;s degree in a Business, Accounting or related field, or an equivalent combination of education and experience.</div></li><li><div>
 3 -5 years of experience in accounting, finance, and/or project management</div></li><div></div><li><div><br>
 1-3 years of supervisory experience that includes financial management as well as performance management and staff development</div></li><li><div>
 Experience with financial contracts, sponsor invoicing, and revenue reconciliation</div></li><li><div>
 Experience with billing compliance requirements and close out procedures</div></li><li><div>
 Excellent written, verbal, and interpersonal communication skills</div></li><li><div>
 Strong attention to detail and proven ability to manage complex workflows</div></li><li><div>
 Demonstrated proficiency in computer software applications including Microsoft products and various databases.</div></li></ul><div></div><div><b><br>
HIGHLY DESIRED QUALIFICATIONS</b></div><ul><li><div>
 Demonstrated experience in clinical trial budget development and negotiation including investigator initiated and industry sponsored trials.</div></li><li><div>
 Demonstrated expertise in complex budget development</div></li><li><div>
 Demonstrated knowledge of Medicare Coverage Analysis and its application to clinical trial</div></li></ul><div></div><p><b><br>
DESIRED QUALIFICATIONS</b></p><ul><li><p>
Experience with insurance and healthcare billing processes</p></li><li><p>
Familiarity with Advarra OnCore CTMS, including financial modules</p></li><li><p>
Knowledge of medical terminology and clinical trial operations</p></li><li><p>
Knowledge of University of Iowa accounting policies, procedures, and systems</p></li></ul><p></p><p><b><br>
Application Process:</b> In order to be considered, applicants must upload <b>a resume and cover letter</b>(under submission relevant materials) that clearly address how they meet the listed required and desired qualifications of this position.</p><p>
Job openings are posted for a minimum of <b>7 </b>calendar days.</p><p>
Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check and credential/education verification.</p><p>
References: Five professional references will be requested and required at a later step in the recruitment process</p><p>
With additional questions, please reach out to Sarah Waldschmidt at sarah-waldschmidt@uiowa.edu</p></div></div>

Clinical Research Finance Manager - Remote - Cancer Center

JenaValve Technology, Inc.

<div><div><div><b>Job Title</b>: Manager, Clinical Affairs (Case Review Board)</div></div><p>
</p><div><div><b>Role Level: </b>Individual Contributor
</div></div><p></p><div><div><b>Manager Title:</b> Senior Director, Clinical Affairs</div></div><p>
</p><div><div><b>Job Location &amp; Environment:</b> Irvine, CA, Corporate Office
</div></div><p></p><div><div><b>Job Description Summary: </b>Reporting to the Senior Director of Clinical Affairs, the Manager, Clinical Affairs (CRB) will be responsible for case planning for global clinical trials and collaborating with internal and external stakeholders (Field Clinical Specialists, Research Coordinators at investigational sites, imaging core laboratories, and Case Review Board) on CRB process development, execution, and improvement. This position provides leadership junior members of Clinical Affairs and support to multidisciplinary project teams, both internally and externally.</div></div><p>
</p><div><div><b>Job Responsibilities:
</b></div></div><ul><li><div>Drive scheduling and executing CRB meetings with committee members and site-level health care providers across all clinical trials.</div></li><li><div>
Oversee the training/coordinating of subject presentation materials for CRB meetings with clinical trial sites.</div></li><li><div>
Collaborate with cross functional team leaders to ensure harmonization of processes and practices for case planning efficiency</div></li><li><div>
Preparation and review of presentation materials for CRB meetings for all clinical trials with site clinical research coordinators, implanters, and field clinical specialists.</div></li><li><div>
Communication with clinical research coordinators and investigators on case approvals, scheduling, lab work, and excluded cases.</div></li><li><div>
Develop and maintain the CRB charters as needed.</div></li><li><div>
Manage and troubleshoot imaging upload and transfer workflow.</div></li><li><div>
Partner with clinical sites and core lab(s) to manage and improve subject screening workflow from initial submission to final approval of inclusion for treatment.</div></li><li><div>
Development, review, optimization, and implementation of standard operating procedures related to case review board workstream.</div></li><li><div>
Serve as the primary point of contact and subject matter expert for patient screening process during study start-up</div></li><li><div>
Maintain and optimize case/subject logs, tracking tools, and regular progress reporting.</div></li><li><div>
Maintain, track, and update existing proctor agreements and partner with the contracting team on any new contracts required for expanded trials.</div></li><li><div>
Manage and maintain relevant electronic data management platform activities related to clinical trial enrollment.</div></li><li><div>
Mentor and provide leadership to junior Clinical Affairs team members through individual development plans and department milestones.</div></li><li><div>
Other duties as assigned.</div></li></ul><div><div><b>
Required Education and Experience:
</b></div></div><ul><li><div>5+ years of relevant professional experience in clinical operations, site management, case planning, patient screening, etc. is required (preferred in medical devices).</div></li><li><div>
Strong background in Microsoft Office Suite, especially PowerPoint and Excel.</div></li><li><div>
Experience facilitating Zoom or Microsoft Teams meetings.</div></li><li><div>
Strict attention to detail.</div></li><li><div>
Ability to interact professionally with all organizational levels.</div></li><li><div>
Ability to lead a team and work in a team environment.</div></li><li><div>
Experience in line management and developing direct reports is strongly recommended.</div></li><li><div>
Advanced degree in a biological science / pharmacy/ nursing desired.</div></li></ul><p>
</p><div><div><b>Skills and Abilities Required for This Job:
</b></div></div><ul><li><div>Working knowledge of clinical study execution and patient screen / case planning.</div></li><li><div>
Knowledge of GCPs governing the conduct of clinical trials; working knowledge of Medical Device Regulations 2017/745, ISO 14155 and ICH Guidelines.</div></li><li><div>
Experience in developing and improving processes.</div></li><li><div>
Ability to work collaboratively as part of a multi-functional medical device development team in a dynamic environment.</div></li><li><div>
Must be self-motivated, highly organized, detail-oriented and able to multi-task, delivering high quality work.</div></li><li><div>
Demonstrated ability in oral and written communication skills; excellent interpersonal skills, including the ability to influence and to work effectively cross-culturally and cross-functionally.</div></li><li><div>
Ability to work in a fast-paced work environment within a cross-functional and highly interdependent team structure.</div></li><li><div>
Ability to work pacific standard time hours.</div></li></ul></div>

Manager, Clinical Affairs (Case Review Board)

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