clinical compliance specialist

Novartis

<div><div><h3 class="jobSectionHeader"><b>Summary
</b></h3><div>The GCP Compliance Specialist (Technology) is accountable to manage delegated activities supporting GCO projects and teams in ensuring compliance against GCP for emerging technology and change of strategy in current GCO managed technology, including awareness of the use of artificial intelligence (AI) and machine learning in GCO operated clinical trials, with the aim to guarantee regulatory adherence in the use of computerized systems and in the collection of electronic data.<br>
The GCP Compliance Specialist (Technology) provides data analytics and reporting support, knowledge in GxP relevant Enterprise IT systems in the frame of GCP Compliance activities and supports the delivery of the GCP Compliance Technology roadmap. This role promotes a product quality culture within GCO supporting the GCP Compliance Head (Technology), focusing on quality and compliance being increased and sustained.</div>
</div><div><h3 class="jobSectionHeader"><b>About the Role
</b></h3><div><p><b>Major accountabilities:
</b></p><ul><li>Contribute to the compliance against GCP for emerging technology and change of strategy in current GCO managed technology via assigned activities.</li><li>
Support the delivery of the GCP Compliance Technology roadmap via assigned activities.</li><li>
Provide data analytics and reporting support in the frame of GCP Compliance activities.</li><li>
Provide day-to-day technical support with knowledge in GxP relevant Enterprise IT systems to GCP Compliance teams and GCO teams.</li><li>
Support the monitoring of relevant indicators/metrics/thresholds if relevant per scope.</li></ul><p></p><p><b>
Key performance indicators:
</b></p><ul><li>Compliance against GCP for emerging technology and current GCO managed technology in case of change.</li><li>
Increased technical capabilities in GxP computerized systems including artificial intelligence (AI) through time, with support provided to GCP Compliance teams and GCO teams and greater ability in partnering within and outside GCO.</li><li>
Timely delivery of GCP Compliance Technology roadmap assigned activities.</li><li>
Support Process, Training &amp; GCP Compliance objectives&rsquo; achievement, ensuring the delivery of GCP Compliance objectives and targets.</li></ul><p></p><p><b>
Minimum Requirements:
</b></p><p><b>Education: </b>Minimum: Bachelor&rsquo;s degree in science, B.Pharma, M.Pharma, Computer Science engineering or relevant discipline.</p><p></p><p><b>
Language: </b>Proficiency in English.</p><p></p><p><b><br>
Experience/Professional requirement:</b></p><ul><li>
5+ years of industry experience, preferably in major Pharmaceuticals company and in particular technical expertise in computerized systems used in clinical operations with an understanding of clinical research international standards and regulatory requirements from Health Authorities.</li><li>
Organizational skills, associated with an aptitude in critical thinking, quality management and continuous improvement.</li><li>
Ability in partnering with a proactive and customer focused solution- oriented mindset.</li><li>
Experienced in change management, intercultural experience, and ability to act in a complex and rapidly changing business environment.</li><li>
Skills to facilitate contribution of team members as individuals and members of a cohesive team.</li><li>
Ability to work in a matrix cross-functional environment.</li><li>
Written and verbal communication skills.</li><li>
Self-awareness, willingness to further develop own strengths and explore opportunities for improvement.</li></ul></div>
</div><div><div><p><b>Why Novartis:</b> Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients&rsquo; lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture</p><p><b>
Join our Novartis Network:</b> Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network</p><p><b>
Benefits and Rewards:</b> Read our handbook to learn about all the ways we&rsquo;ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards</p></div></div></div>
<br><div><div>Division
<div>Development
</div></div><div>Business Unit
<div>Development
</div></div><div>Location
<div>India
</div></div><div>Site
<div>Hyderabad (Office)
</div></div><div>Company / Legal Entity
<div>IN10 (FCRS = IN010) Novartis Healthcare Private Limited
</div></div><div>Functional Area
<div>Research &amp; Development
</div></div><div>Job Type
<div>Full time
</div></div><div>Employment Type
<div>Regular
</div></div><div>Shift Work
<div>No
</div></div><div>
</div><div><h3 class="jobSectionHeader"><b>Accessibility and accommodation</b></h3><p>
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.</p>
</div><div><p>Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.</p></div></div><div></div>

GCP Compliance Specialist/Manager (Technology)

Ecorgy Solutions Private Limited

<p><b>Responsibilities:</b></p><ul><li>Evaluate clinical procedures and documentation to identify areas for improvement, ensuring adherence to industry standards.</li><li>Conduct compliance audits and assessments to provide continuous improvement feedback and maintain industry compliance.</li><li>Prepare and engage in client audits, including regular mock audits, ensuring preparedness and compliance.</li><li>Stay updated on industry regulations, clinical guidelines, and best practices to ensure compliance and innovation.</li><li>Communicate quality-related issues and recommendations to stakeholders efficiently.</li><li>Engage in quality-focused training and educational programs for continuous professional development.</li></ul><p><b>Qualifications:</b></p><ul><li>BAMS/ BHMS/ BDS/ Pharm D</li><li>0-5 years of clinical or healthcare setting experience.</li><li>Profound knowledge of medical terminology and clinical processes.</li><li><b>Good computer skills (Typing speed, MS Excel/Word) </b>- Mandatory.</li><li><b>Excellent English communication</b>, written and verbal - Mandatory.</li><li>Willing to work in night shifts <b>(10:30PM to 7:30AM)</b> - Mandatory.</li></ul><p>Job Type: Full-time</p><p>Pay: &#8377;25,000.00 - &#8377;35,000.00 per month</p><p>Application Question(s):</p><ul><li>How many years of experience do you have?</li><li>Are you okay to work in night shifts (10:30PM to 7:30AM) on regular basis?</li><li>Are you located in Trivandrum or at commutable distance?</li><li>We must fill this vacancy urgently. Are you available immediately for joining?</li></ul><p>Work Location: In person</p>

Clinical Quality Manager - Doctors (Trivandrum)

CVS Health

<div><p>At CVS Health, we&rsquo;re building a world of health around every consumer and surrounding ourselves with dedicated colleagues who are passionate about transforming health care.</p><p></p><p>
As the nation&rsquo;s leading health solutions company, we reach millions of Americans through our local presence, digital channels and more than 300,000 purpose-driven colleagues &ndash; caring for people where, when and how they choose in a way that is uniquely more connected, more convenient and more compassionate. And we do it all with heart, each and every day.</p><p></p><p><b>
Position Summary</b></p><p>
This position will be working from home anywhere in the continental US.</p><p>
Standard business hours Monday-Friday.</p><ul><li>
Accountable for conducting oversight of entities that are contracted to perform clinical functions on Aetna's behalf.</li><li>
Monitor and track delegated entities compliance with regulatory and NCQA requirements.</li><li>
Communicate to delegated entities about industry standards, Aetna policies, and best practices.</li><li>
Accountable for preparing delegation oversight resources for NCQA and regulatory reviews</li><li>
This position supports NCQA, CMS, and other regulatory compliance initiatives.</li></ul><p><b><br>
Required Qualifications</b></p><ul><li>
3&ndash;5 years of experience in Quality Management within the healthcare industry</li><li>
Demonstrated ability to consistently meet deadlines in a fast-paced environment</li><li>
Strong communication and interpersonal skills, with a proven ability to collaborate effectively across teams</li></ul><p><b><br>
Preferred Qualifications</b></p><ul><li>
2 to 3 years prior experience working in Commercial/Medicare or Medicaid lines of business</li><li>
Medical Terminology and Claims Experience</li><li>
QuickBase Experience</li><li>
Experience with flexing and shifting priorities</li><li>
Experience working independently and collaboratively to solve problems, make decisions, and complete work/projects</li><li>
Growth mindset (developing yourself and others) skills</li></ul><p><b><br>
Education</b></p><ul><li>
Bachelors Degree Preferred</li></ul><p></p><p><b>
Anticipated Weekly Hours</b></p>
40<p></p><p><b>
Time Type</b></p>
Full time<p></p><p><b>
Pay Range</b></p><p>
The typical pay range for this role is:</p><p></p>
$43,888.00 - $102,081.00<p></p><p>
This pay range represents the base hourly rate or base annual full-time salary for all positions in the job grade within which this position falls. The actual base salary offer will depend on a variety of factors including experience, education, geography and other relevant factors. This position is eligible for a CVS Health bonus, commission or short-term incentive program in addition to the base pay range listed above.</p><p><br>
Our people fuel our future. Our teams reflect the customers, patients, members and communities we serve and we are committed to fostering a workplace where every colleague feels valued and that they belong.</p><p></p><p><b>
Great benefits for great people</b></p><p></p><p>
We take pride in our comprehensive and competitive mix of pay and benefits &ndash; investing in the physical, emotional and financial wellness of our colleagues and their families to help them be the healthiest they can be. In addition to our competitive wages, our great benefits include:</p><ul><li><p><b>
Affordable medical plan options,</b> a <b>401(k) plan </b>(including matching company contributions), and an <b>employee stock purchase plan</b>.</p></li><li><p><b>
No-cost programs for all colleagues </b>including wellness screenings, tobacco cessation and weight management programs, confidential counseling and financial coaching.</p></li><li><p><b>
Benefit solutions that address the different needs and preferences of our colleagues</b> including paid time off, flexible work schedules, family leave, dependent care resources, colleague assistance programs, tuition assistance, retiree medical access and many other benefits depending on eligibility.</p></li></ul><p></p><p>
For more information, visit https://jobs.cvshealth.com/us/en/benefits</p><p></p>
We anticipate the application window for this opening will close on: 11/21/2025<p></p><p>
Qualified applicants with arrest or conviction records will be considered for employment in accordance with all federal, state and local laws.</p></div>

Analyst, Health Care Quality Management - Work at Home

Cook Children's Health Care System

<div><div>Location:</div><div></div>
Rosedale Office Building<div></div><div>
Department:</div><div></div>
Accred Compliance<div></div><div>
Shift:</div>
First Shift (United States of America)<div></div><div>
Standard Weekly Hours:</div><div></div>
20<div></div><div>
Summary:</div><div></div><div>
The Clinical Contract Specialist oversees and manages all clinical contracts that impact patient care across the organization. This position ensures all contracts remain current, compliant, and supported by measurable performance metrics that are routinely tracked. The Specialist maintains consistent communication with department leaders to verify timely completion of deliverables and works closely with leadership to assess contract performance. This role manages a comprehensive clinical contract database, conducts regular reviews across systems, and prepares detailed performance reports for leadership and the board. The Clinical Contract Specialist partners frequently with legal counsel and departmental leadership to ensure all contractual obligations are fulfilled.</div><div></div><div>
Experience</div><ul><li><div>
3 years of experience in contract management, healthcare administration, or related field in an acute care setting required.</div></li><li><div>
Demonstrated proficiency in contract review, clinical compliance, or data analysis required.</div></li></ul><div></div><div>
Education</div><ul><li><div>
Bachelor&rsquo;s degree in Business Administration, Finance, Healthcare Administration, or related field required.</div></li></ul><div></div><div>
About Us:</div><div></div><div>
Cook Children's Health Care System</div><div></div><div>
Cook Children's Health Care System offers a unique approach to caring for children because we are one of the country's leading integrated pediatric health care delivery organizations. Patients benefit from the integrated system because it allows Cook Children's to use all of its resources to treat a patient and allows for easy communication between the various companies by physicians with a focus on caring for children and adolescents.</div><div></div><div>
Cook Children&rsquo;s is an equal opportunity employer. As such, Cook Children&rsquo;s offers equal employment opportunities without regard to race, color, religion, sex, age, national origin, physical or mental disability, pregnancy, protected veteran status, genetic information, or any other protected class in accordance with applicable federal laws. These opportunities include terms, conditions and privileges of employment, including but not limited to hiring, job placement, training, compensation, discipline, advancement and termination.</div></div>

Clinical Contract Specialist

Lumos Pharma, Inc.

<div><div><b>Clinical Quality Assurance Specialist</b></div>
<div></div><div>Lumos Pharma is a clinical-stage biopharmaceutical company whose mission is to develop new therapies for people with rare diseases, prioritizing its focus where the medical need is high, and the pathophysiology is clear. We are committed to this mission and a strategy grounded upon time and cost-efficient drug development to deliver safe and effective therapies to patients. We take a patient-centric approach and maintain inspection-readiness across our programs.</div>
<div></div><div>This position reports to the Vice President, Quality and Compliance, and is responsible for providing quality oversight of clinical trial activities performed in compliance with Good Clinical Practices (GCP). This position also supports internal quality systems and compliance functions. The Clinical Quality Assurance Specialist is expected to execute established processes involving quality assurance, quality systems, and compliance.</div>
<div></div><div>ESSENTIAL FUNCTIONS</div>
<ul><li>Author, review, and/or approve SOPs, protocols, study plans, and other applicable clinical documents in accordance with GCP requirements</li>
<li>Provide input on protocol deviations and associated corrective/preventive actions involving clinical trials.</li>
<li>Perform audits of clinical trial sites and clinical studies (e.g., trial master file, clinical study report, etc.)</li>
<li>Complete required tasks in the electronic quality management system</li>
<li>Assist with training coordination, ensuring employees are up to date on quality and compliance requirements</li>
<li>Assist with audits of external suppliers</li>
<li>Routinely work with internal and external stakeholders to achieve cross-functional goals.</li>
<li>Each employee is responsible for financial and compliance controls as they relate to their roles. For example, being fiscally responsible in purchasing decisions and completing compliance training within the specified time frames.</li>
</ul><div><div><div>REQUIRED QUALIFICATIONS</div>
<div></div><div>Education</div>
<ul><li>Bachelor's Degree (four-year college or technical school) required, Field of Study: Biology, Chemistry, Health Administration, or related technical discipline</li>
</ul><div>EXPERIENCE</div>
<ul><li>1-3 years of experience in quality assurance within the pharmaceutical or biotech industry</li>
</ul>
<div></div><div>PREFERRED QUALIFICATIONS</div>
<ul><li>Knowledge of GMP and GCP regulations</li>
<li>Strong attention to detail, documentation accuracy, and organizational skills</li>
<li>Microsoft Office</li>
<li>Experience with MasterControl is desirable</li>
<li>Experience with CDER BIMO inspections is desirable</li>
</ul>
<div></div><div>COMPETENCIES</div>
<ul><li>Analytical Skills: Strong analytical skills with a strategic mindset for clinical development and commercialization.</li>
<li>Communication: Excellent communication skills, with the ability to clearly articulate complex scientific information to technical and non-technical audiences.</li>
<li>Relationship Builder: Ability to work effectively in a cross-functional team environment and to build relationships with internal and external stakeholders.</li>
<li>Business Acumen: Business acumen is the ability to understand and discriminate between various business-related topics and issues.</li>
<li>Decision-Making/Judgment: Decision-making skills look at the ability of the individual to select an effective course of action while controlling resources and expenditures.</li>
</ul>
<div></div><div>WORK ENVIRONMENT</div>
<div>This position can work remotely in the United States.</div>
<div></div><div>TRAVEL EXPECTATION</div>
<div>Up to 10%</div>
<div></div><div>What you can expect as a Lumosian</div>
<ul><li>Industry-competitive compensation</li>
<li>Generous health and welfare benefits, including company-paid dental and vision benefits with dependents coverage, short-term and long-term disability, and basic life Insurance.</li>
<li>Lumos covers 85 &ndash; 95% of the medical premium</li>
<li>Health Reimbursement Arrangement</li>
<li>8 weeks of fully paid parental leave for all new parents</li>
<li>Gym or fitness class reimbursement</li>
<li>401(k) with 5% employer contribution</li>
<li>Flexible work hours and location</li>
<li>Generous PTO policy</li>
<li>11 paid holidays in the US</li>
<li>Offices in Austin, TX, and Ames, IA</li></ul></div></div></div><div></div>

Clinical Quality Assurance Specialist

Search 10000+ Clinical compliance specialist jobs near you this November. New roles added regularly across leading industries. Apply today.

10000 clinical compliance specialist jobs NEAR_ME

GCP Compliance Specialist/Manager (Technology)

Clinical Quality Manager - Doctors (Trivandrum)

Analyst, Health Care Quality Management - Work at Home

Analyst, Health Care Quality Management - Work at Home

Analyst, Health Care Quality Management - Work at Home

Clinical Contract Specialist

Clinical Quality Assurance Specialist