Clinical Research Remote Jobs in Mississippi (US)

This page tracks remote clinical research openings that are location-eligible for Mississippi.

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$29 - $160,000

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587 Companies

Stroke/Core Measures Clinical Services Lead

Q-Centrix

Clinical Data With a Purpose

Clinical Research5 hours ago

Full Time Remote LeadTeam 1,001-5,000H1B No Sponsor

Company Site LinkedIn

Role Description Under the direction of the Manager or Senior Manager, the Clinical Services Lead plays a vital role in the account team, driving partner satisfaction through continuous communication and effective project management. The Clinical Services Lead is responsible for ensuring partner deliverables are met during new implementations and ongoing projects by monitoring and prioritizing case workflows and addressing first-tier service issues. As a key member of the clinical leadership team, this role collaborates closely with Clinical Data Leads, Clinical Data Quality Specialists, the abstraction team, and Client Services management to ensure high-quality service delivery to our partners. Roles and Responsibilities - Oversee deadlines, team productivity, and case completion providing follow-up as necessary to ensure partner deliverables are met and target service line operational goals are achieved. - Coach team members on missed deadlines and inform SM/MCS of missed deadlines. - Create case assignments. - Monitor partner case volumes and hours to ensure teams are properly staffed to meet partner turnaround time, and request resource adjustments as needed. - Review key operating metrics to provide data driven recommendations to support business financial goals. - Serve as our partners’ primary point of contact for Client Services. - Maintain high levels of partner satisfaction by driving engagement and anticipating customer needs through ongoing communication, including scheduling and facilitating partner meetings and agendas. - Responsible for overall deliverables to partners including meeting deadlines, data submission agreements, and service agreements as outlined in the partner contract. - Champion the use of QC technology to streamline internal workflows and providing technology demonstrations for partners, as needed. - Proactively identify risk to partner satisfaction and escalate to SM/MCS. - Act as primary owner within Client Services for new implementations, reporting out on status when asked and serving as the point to solve implementation delays by working closely with the Project Manager and SM/MCS. - Participate in process improvement work to support overall Q-Centrix or Client Services department initiatives. - Discuss quality performance opportunities with partners to decrease fallout reviews or enhance quality outcomes. - Other quality tasks, as assigned. Qualifications - Strong analytical and critical thinking skills to approach problems in a systematic method using the ability to synthesize data and suggest recommendations. - Demonstrates high standards for accuracy and attention to detail. - Demonstrates technical savvy and adeptness to learn new systems and technology. - Thrives working independently and takes ownership of projects. - Consistently and clearly communicates, adjusting style and tone as needed to effectively collaborate with hospital partners, peers, abstractors and others. - Demonstrates strong self-organizational and time management skills to concurrently manage multiple accounts, adjusting as needed to shifting timelines and priorities. - Adapts to changes in project timelines, requirements, and assignments. - Maintains a high degree of responsibility in keeping PHI secure and confidential. Requirements - Familiar with hospital Core Measures and/or the Get With the Guidelines Stroke registry. - Intermediate proficiency with MS Office (Microsoft Excel). - Exposure to multiple patient medical record systems (EMRs) and clinical databases. - 1+ years providing coaching and guidance to teams (preferred). - Experience with evaluating operating financial metrics (preferred). - RN, LPN, RT, RVT, or RCIS credentials (preferred). Benefits - A fully remote work environment with flexible schedule and a generous Paid Time Off program with additional paid time for volunteering. - Robust benefits package including medical, vision, dental, health savings accounts, company paid short- and long-term disability, employee assistance program, paid parental leave, life insurance, accident insurance, and other voluntary benefit programs for employees and their eligible dependents. - 401(k) retirement plan with a company match. - Paid professional development hours and other supportive resources.

View details: Stroke/Core Measures Clinical Services Lead

United States

$32 - $34 / hour

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Vice President of Finance

ESO

ESO is a fast-paced, growing data, technology, and research company passionate about improving community health and safety through the power of data. We pioneer innovative, user-friendly software to meet the changing needs of today’s EMS agencies, fire departments, and hospitals. We’re small enough to be nimble and fun, but big enough to be a great place to work. We serve thousands of customers out of our offices across the US, Canada and Northern Ireland.

Clinical Research17 hours ago

Full Time Remote Mid Level

Role Description The Vice President of Finance is a hands-on leadership role reporting to the Chief Financial Officer. The VP will be directly involved in the work: - Building models - Reviewing ARR - Pressure-testing forecasts - Sitting alongside business leaders to drive decisions The VP will inherit and lead a team of approximately 7 finance professionals, with the opportunity to continue building that organization as ESO grows. This person will serve as a key strategic partner to ESO’s Executive Leadership Team. This role consolidates strategic finance and FP&A leadership into a single seat, covering everything from long-range planning and pricing strategy to ARR analytics, debt management, and exit readiness. The VP will regularly engage with ESO’s board, Vista Equity Partners, and lenders, and will be a visible, credible voice for finance across the organization. ESO is a remote-first company, requiring someone who knows how to lead with presence and intention across a distributed team and organization, building trust and connection without the benefit of shared physical space. ESO operates in a genuinely complex business environment. Our customer base spans the full spectrum of the market, from small volunteer fire departments to large municipal EMS agencies and health systems, each with distinct economics, buying behaviors, and retention profiles. Our product portfolio is broad, serving multiple segments across software, data, and analytics. We are actively bringing AI-powered products to market, which means this VP will help build the financial frameworks, P&L structures, and ARR analytics needed to track and manage an emerging and strategically critical new revenue stream. ESO has employees and operations across the US, UK, Czech Republic, Denmark, Costa Rica, India, and Australia, with approximately $200M in revenue. The right candidate has operated in environments of similar complexity and knows what it takes to build finance capability while keeping the trains running. Qualifications - Bachelor’s degree in Finance required; MBA strongly preferred. - 15+ years of progressive finance leadership experience, including experience in a complex global company with employees and operations across multiple regions and countries. - Demonstrated ability to lead in a player-coach capacity: setting strategy, building teams, and rolling up sleeves to do the work simultaneously. - A collaborative, low-ego leader who builds trust quickly across functions and brings out the best in the people around them. - Proven ability to lead and build relationships in a remote-first environment, creating connection, accountability, and team culture without the benefit of shared physical space. - Proven success in SaaS or recurring revenue businesses with diverse customer segments and broad product portfolios, including deep expertise in ARR frameworks, SaaS metrics, and subscription economics. - Experience building financial frameworks for AI or emerging product lines is a strong plus. - Experience in private equity-backed environments, with a track record of supporting value creation and exit processes. - Strong FP&A and strategic planning credentials, including experience with long-range modeling, scenario analysis, and board-level financial storytelling. - Hands-on experience with Adaptive Planning (implementation experience a strong plus), NetSuite, Salesforce, and BI tools. - Experience with cash flow forecasting, debt management, covenant reporting, and EBITDA management in a leveraged capital structure. - Proven ability to lead pricing strategy and support M&A due diligence and integration. - Demonstrated success building Finance Business Partner organizations that are trusted partners to the business, not just reporters of results. - Passion for AI, data-driven decision-making, and building a finance culture that moves at the speed of the business. - Exceptional communication and cross-functional collaboration skills; equally comfortable in a board room and in a spreadsheet. Requirements - Lead all financial planning, budgeting, and forecasting across ESO, ensuring rigor, accuracy, and connection to business reality. - Build and lead ESO’s Finance Business Partner organization, embedding dedicated finance partners across Sales & Marketing, Operations & Support, and Technology & Product. - Drive alignment between financial forecasts and corporate strategy, translating business priorities into financial implications. - Lead revenue forecasting processes across all business units, partnering with Sales, Product, and Strategy teams. - Build out P&L reporting by business and customer segment. - Serve as a hands-on thought partner to functional and business leaders. - Deliver timely, accurate, and insightful financial reporting across the organization. - Implement and leverage advanced analytics and visualization tools. - Own all corporate financial reporting, ensuring materials are accurate, insight-driven, and delivered on time. - Lead the preparation of Board of Directors decks. - Drive the monthly operating review (MOR) process. - Lead quarterly business reviews (QBRs). - Support company-wide communications including town halls. - Prepare Vista reporting packages and any ad hoc materials required for investor or sponsor engagement. - Provide deep analytical insight into the ARR snowball. - Translate SaaS metrics into business implications. - Build and maintain ARR analytics and P&L frameworks for ESO’s AI product lines. - Partner closely with the Accounting team on ESO’s ARR framework. - Collaborate with the CFO and Chief Strategy Officer to develop and maintain long-range financial plans and scenario models. - Develop and refine pricing strategies to optimize revenue and customer value. - Provide financial support to corporate development and partnership initiatives. - Partner with the Chief Strategy Officer and Corporate Development on financial due diligence. - Support integration planning and execution for acquisitions. - Monitor and report on financial performance of acquired entities. - Lead weekly and monthly cash flow forecasting. - Collaborate with Treasury and Accounting to monitor cash positions. - Provide proactive, scenario-based insights to support strategic cash management decisions. - Partner with Vista Equity Partners and ESO leadership to identify and execute value creation initiatives. - Lead financial readiness efforts for potential exit scenarios. - Oversee covenant compliance and reporting in alignment with ESO’s debt agreements. - Ensure accurate tracking and rigorous justification of EBITDA addbacks. - Lead the preparation of lender review materials. - Support ongoing lender relationship management. - Collaborate with Legal and external advisors to maintain transparency and audit readiness. - Drive automation and system enhancements across financial planning, reporting, and analysis. - Lead and actively participate in ESO’s Adaptive Planning implementation. - Partner with Finance and IT teams on NetSuite optimization. - Champion the use of AI and advanced analytics to modernize financial processes. Benefits - Competitive health plans (medical, dental, & vision insurance) - PTO (starting at 20 days) & 12 company holidays - 401(k) with company match - Telemedicine service provided by ESO - Savings accounts (FSA, HSA, DCA) - Employee Assistance Program (EAP) - Peace of mind benefits such as life insurance, disability insurance, and worksite benefits - Paid parental leave, new child program, & flexible parental return-to-work options

View details: Vice President of Finance

Worldwide

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Clinical Research Physician - Oncology

Lilly

Lilly is a global biotechnology and pharmaceuticals healthcare company. Founded by Colonel Eli Lilly in 1876, the company is based in Indianapolis, Indiana, and maintains a strong

Clinical Research22 hours ago

Full Time Remote Mid Level

Role Description As a Clinical Research Physician (CRP), you'll bring your scientific training and clinical experience to the heart of how we develop and deliver medicines. You'll play a central role across the product lifecycle — from designing and running global clinical trials through to registration, commercialization, and beyond. - Contribute to protocol development, study reporting, and data dissemination. - Review publications, support labeling updates, and help shape documents for pricing, reimbursement, and access. - Ensure adverse events are reported in line with patient safety standards. - Engage with regulatory agencies and external thought leaders to advance our science. - Serve as a key scientific resource — advising study teams and supporting medical activities. - Uphold the highest standards of compliance with applicable regulations (FDA, ICH, CPMP), Good Clinical Practices, Lilly policies, and the Principles of Medical Research. Qualifications - Medical Doctor. Must be board eligible or certified in appropriate specialty/subspecialty or have completed comparable post-medical school clinical training relevant to the country of hiring. - Experience of international oncology practice. - Fluent in English; both written and verbal communications. - Demonstrated knowledge of the drug development process. Requirements - In-depth knowledge of breast oncology. - Experience with CDK 4 & 6 inhibitors. - Demonstrated strong communication, interpersonal, organizational, teamwork, and negotiation skills. - Demonstrated ability to influence others cross-functionally. - Ability to engage in domestic and international travel as needed. - Clinical research or pharmaceutical medicine experience preferred. Company Description Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. - Over 50,000 employees globally. - Focus on discovering and delivering life-changing medicines. - Commitment to improving the understanding and management of disease. - Engagement in philanthropy and volunteerism.

View details: Clinical Research Physician - Oncology

United States + 9 more

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Assistant Clinical Research Associate

Thermo Fisher Scientific

The World Leader In Serving Science

Clinical Research22 hours ago

Full Time Remote Mid LevelTeam 10,001+Since 1956H1B Sponsor

Company Site LinkedIn

Role Description Join Us as an Assistant Clinical Research Associate – Make an Impact at the Forefront of Innovation. As part of our global team, you’ll have the opportunity to perform remote activities on assigned projects in liaison with the CRA and study Clinical Lead. As an Assistant Clinical Research Associate, you'll provide support with site preparedness, logistical support to the monitoring process, and assist with assigned tasks for site management and remote monitoring in accordance with SOPs and regulatory guidelines. You may be assigned limited site contact activities during study start-up, site management, recruitment, and close-out phases. - Completes study and site management activities as defined in task matrix, and as applicable and directed for study assigned. - Completes and documents study-specific training. - Orients and trains on any study-specific systems. - Provides in-house support during pre-study assessments and with pre-study assessment waivers, as agreed for project. - Supports to customize Site ICF with site contact details, as needed. - Performs remote review of EMR/EHR checklist and supports collection, as applicable assessments. - Verifies document collection and RCR submission status; updates site EDL and verifies site information. - Reviews patient facing materials and review translations, as directed. - Supports site staff with the vendor related qualification process, where applicable. - Provides support by ensuring system access is requested/granted and revoked for relevant site staff during pre-activation and subsequent course of the study. - Provides support to follow-up on site staff training, as applicable. - Coordinates and supports logistics for IM attendance, as directed. - Supports maintenance of vendor trackers, as directed. - Coordinates study/site supply management during pre-activation and subsequent course of the study. - Supports Essential Document collection, review and updating in systems, as applicable. - Follows up and supports on missing study vendor data like ECGs, lab samples, and e-diaries, as directed. - Supports ongoing remote review of centralized monitoring tools, as directed. - Supports Site payments processes by coordinating with various functional departments within organization and site. Supports system updates and reconciliations, as directed and follows-up on site invoices throughout the study period. - Performs reconciliation tasks on assigned trials including but not limited to CRF and query status, deviations, SAEs and safety reports, as applicable. - Verifies document collection status in company systems and drives action for missing/incomplete/expired documents and open document findings, as directed. - May perform other assigned site management tasks, as directed by CRA and as per Task Matrix. - May perform a specific role profile for FSP opportunities according to Client requests. - Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner. Qualifications - Bachelor's degree in a life science discipline or related field or a Registered Nursing certification or equivalent and relevant formal academic/vocational qualification. - Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years). - In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Requirements - Basic medical/therapeutic area knowledge and understanding of medical terminology. - Ability to attain and maintain a working knowledge of ICH GCP, applicable regulations and company procedural documents. - Effective oral and written communication skills. - Excellent interpersonal and customer service skills. - Good organizational and time management skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively. - Proven flexibility and adaptability. - Ability to work in a team or independently, as required. - Well-developed critical thinking skills, including but not limited to critical mindset, in-depth investigation for appropriate root cause analysis and problem solving. - Proficient computer skills with good knowledge of MS Office ability to learn and use appropriate software. Leverage modern technology when applicable. - Ability to extract pertinent information from all study documents, electronic study data systems, CTMS and dashboards. - Excellent English language and grammar skills. Working Conditions and Environment - Work is performed most of the time in an office or home office environment; occasional travel to clinics/hospitals may be required. - Exposure to electrical office equipment. - The Assistant CRA role does not involve regular travel; however, any direct, promotional opportunities in the CRA career track will require frequent travel (60-80%).

View details: Assistant Clinical Research Associate

Worldwide

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Veterinary Clinical Pathologist

CareAbout

Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Join us at Altasciences!

Clinical Research22 hours ago

Full Time Remote Mid LevelTeam 1,001-5,000

Role Description Veterinary Clinical Pathologists will serve as a Clinical Pathologist on nonclinical safety studies. The critical and main function of the position will be interpreting data and writing clinical pathology reports (GLP and nonGLP), collaborating with Study Directors and Anatomic Pathologists, and other relevant personnel. This is a North America based remote position. What You'll Do Here - Evaluate clinical pathology data and prepare reports for nonclinical safety studies. - Support Study Directors in addressing clinical pathology related data and issues with sponsors. - Support client development through discussions with sponsors about study goals and designs. - Implement/support company-wide scientific initiatives involving the Clinical Pathology department as assigned. - Support continuing development of Study Directors and other Safety Assessment personnel. - Other duties as assigned. Qualifications - D.V.M. (or Equivalent as listed by AVMA ECFVG) required. - MS/MVSc/MSc, and/or Ph. D. preferred. - Minimum 1-4 years experience as a Veterinary Clinical Pathologist (as board eligible trainee or board certified), ideally with pharma, biotech, and/or CRO experience. - DVM, Diplomate ACVP, ECVP in Veterinary Clinical Pathology. - Ability to utilize Microsoft Office and pathology data management systems. - Proficiency in both written and verbal English; ability to read, analyze, and interpret common scientific and technical journals; ability to respond to common inquiries or complaints from customers or regulatory agencies; and, ability to effectively present information to clients, management, and public groups. - Ability to utilize appropriate mathematical concepts for interpreting scientific studies. - Training needs for this position may include continuing education in toxicology and pathology. Continual GLP training. - Additional skills required include, but are not limited to: general reading, writing, and verbal communication skills; and skills in scientific writing or electronic publishing. - Preferred skills include, but are not limited to: demonstrates expertise in clinical pathology; demonstrates knowledge of current scientific and industry specific literature; ability to successfully operate independently with minimal guidelines; and has excellent interpersonal and communication skills. Benefits - The salary range estimated for this position is $160,000 - $200,000. Please note that salaries vary within the range based on factors including, but not limited to, prior relevant experience, skills, education, certification, location as well as internal equity and market data. - Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work. - Health/Dental/Vision Insurance Plans. - 401(k)/RRSP with Employer Match. - Paid Vacation and Holidays. - Paid Sick and Bereavement Leave. - Employee Assistance & Telehealth Program. Company Description Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Join us at Altasciences!

View details: Veterinary Clinical Pathologist

United States + 1 more

$160K - $200K / year

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Patient Service Center Clinical Support Specialist

Indiana Health Centers, Inc.

IHC specializes in integrated care, providing access to essential services to meet the needs of patients in the community. With ten healthcare centers, eight Women, Infants, and Children (WIC) nutrition program locations, a Mobile Health Unit, and in-house Pharmacy services (select locations), we offer primary medical, dental, and behavioral healthcare services to diverse community-based patient populations throughout Indiana.

Clinical Research23 hours ago

Full Time Remote Mid LevelTeam 201-500

Role Description The PSC Clinical Support Specialist is responsible for coordinating patient referrals and managing prior authorizations to ensure timely access to healthcare services. This role serves as a liaison between patients, providers, insurance companies, and specialty clinics to facilitate efficient care coordination. The specialist ensures all referrals and/or authorization documentation is complete, accurate, and compliant with payer requirements. - Prepare and submit prior authorization requests for procedures, medications, imaging, and specialty services. - Collect and compile required clinical documentation to support authorization requests. - Communicate with insurance companies to obtain approval, provide additional information, or resolve authorization issues. - Monitor authorization status and follow up on pending requests to prevent delays in care. - Document authorization numbers, approvals, denials, and expiration dates in the EHR. - Process incoming and/or outgoing patient referrals to specialty providers, diagnostic services, and ancillary care. - Verify referral/PA requirements based on insurance guidelines and payer policies. - Coordinate with providers and specialists to schedule referred services. - Track referral/PA statuses to ensure completion of appointments and continuity of care. - Communicate referral information and appointment instructions to patients. - Assist in training new staff for the Patient Service Center. - Send and follow up on referrals, complete Prior Authorizations (PA), schedule Diagnostic Imaging tests, and other patient care related paperwork. - Process appropriate patient paperwork in a timely manner. - Educate patients regarding documents they will need to provide at the time of service. - Accurately enter, maintain, and retrieve data on IHC’s Electronic Medical Records (EMR) system. - Communicate appropriate diagnostic and clinical information with patients as needed. - Communicate with patients care team as necessary. - May assist with contacting patients for reminder calls and follow-up. Qualifications - MA, LPN, or RN (required) - Lives in the state of Indiana (required) Requirements - PSC Clinical Support Specialist is required to be a Medical Assistant (must have completed Medical Assisting degree or certificate program), LPN, or RN (valid Indiana licenses in good standing). - Lives in the state of Indiana (required) - Knowledge and experience with both Medication and Imaging Prior Authorizations. - Experience with referrals to specialists. - Document management experience. - One (1) year of prior experience in an office or health-related position preferred. Related education can substitute for experience. - Knowledge of insurance verification and payer authorization processes preferred. Benefits - $1000.00 retention bonus paid after one year - No nights or weekends - Generous Paid Time Off and Floating Holidays - Day 1 Insurance benefits eligibility - 403(b) Retirement Plan matching at one year of employment - Employer-paid Group Life, Short-term disability, and Long-term disability coverages and HSA employer contributions - Flexible Leave of Absence programs - Personify Health Wellness program with paid incentives for participation - Employee Assistance Programs with 24/7 access to therapy consultation services

View details: Patient Service Center Clinical Support Specialist

United States

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Clinical Trial Manager

Natera

We are a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health.

Clinical Research23 hours ago

Full Time Remote LeadTeam 1,001-5,000Since 2004H1B Sponsor

Company Site LinkedIn

• Manage the execution and conduct of all aspects of very complex clinical studies to ensure that timelines, cost, and quality metrics are met. • Responsible for selection of vendors/CROs and provide effective ongoing management to vendors/CROs working on the project to ensure compliance and execution of project deliverables within the approved budget, study timeline, and study protocol. • Manage study contracting, budget, forecasting, accruals and payment process for all clinical trial vendors including investigational sites. • Lead study-related activities such as protocol and informed consent preparation, investigator selection, study training material development and delivery, monitoring plans development and execution. • Collaborate with Clinical Data Management group to ensure correct CRFs content is collected, prepare comprehensive completion guidelines, and design effective data listings and study reports. • Train CROs, vendors, investigators and study coordinators on implementation of study protocol. • Hire, train and oversee Clinical trial staff, and serve as a resource for others within the company for clinical trials management expertise. • Monitor and track clinical trial progress and provide status update to stakeholders. • Support prospective sample testing for studies where Natera functions as a central testing facility. • Partner with other research and development groups to create a culture of mutual respect and focus on delivery of high-quality project results. • Develop Clinical Department SOPs and participate in audits as needed.

View details: Clinical Trial Manager

United States

$138.6K - $173.3K / year

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Clinical Study Manager

Artex Risk Solutions

We believe in finding you a better way.

Clinical Research1 day ago

Full Time Remote SeniorTeam 501-1,000Since 1997H1B No Sponsor

Company Site LinkedIn

• Planning, executing, managing, and oversight of clinical studies and projects according to Research ethics guidelines, ISO standards, internal SOPs, and portfolio priorities • Serve as a cross-functional lead within an assigned study portfolio, ensuring alignment across Clinical Operations, Product Management, Data Management, Regulatory, Compliance, and other key stakeholders • Provide accurate, timely status reports and portfolio-level updates on assigned clinical research studies and projects • Facilitate appropriate documentation to maintain compliance with the AP and Compliance department for HCP transfers of value • Facilitate clinical contract agreements between Arthrex and the Site for studies • Assist the data management team with electronic data capture systems CRF design, eTMF design, CTMS design and user testing for assigned studies • Provide centralized communication and coordination between research sites and internal cross-functional stakeholders • Facilitate site training for data collection clinical research initiatives • Monitor data collection compliance and communicate with sites to optimize data collection • Provide the main line of communication with research sites • Facilitate IRB approval at the site and sponsor level • Oversee and approve site activation activities for studies, ensuring readiness across all functional areas • Collaborate on reviewing protocols, case report forms, and informed consent for clinical studies • Qualify sites for participation in assigned studies • Complete central, remote, and on-site monitoring visits, reports, and follow-up letters • Identify study- and portfolio-level risks or issues, implement mitigation strategies, and develop CAPA plans as appropriate • Works closely with the other clinical research professionals and cross-functional partners to ensure successful study execution • Conduct regular investigator meetings to ensure protocol compliance and site engagement • Actively participate in research committees, study groups, and cross-functional portfolio governance activities to support continuous improvement and strategic alignment • Engage in and support departmental initiatives and cross-functional team projects, collaborating by driving execution, problem-solving, and achievement of key business outcomes

View details: Clinical Study Manager

United States

$84K - $110K / year

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Senior Biostatistician

Foundation Medicine

Based in Cambridge, Massachusetts, Foundation Medicine develops, manufactures, and markets genomic analysis diagnostics for circulating and solid cancers. Dedic

Clinical Research1 day ago

Full Time Remote Senior

Company Site

Role Description The Senior Biostatistician is responsible for independently providing statistical expertise and managing the activities for personalized medicine companion diagnostic device analytical and clinical studies to ensure valid and efficient study designs that allow clearly interpretable results and timely delivery of data analyses, study reports and regulatory documents with high quality. The incumbent independently mentors junior staff; builds and maintains strong collaboration with other teams across the organization to develop study plans, study protocol, and decision framework as well as provide responses to statistical issues arising in regulatory or external partners. The function contributes to the long-term growth strategy of the Scientific Operations team by participating in process improvement initiatives and contributing to the development of statistical methodologies applicable to companion diagnostic validation. Key Responsibilities - Lead independently the design and data analysis of analytical and clinical validation studies on novel next generation sequencing-based companion diagnostic devices for oncology. - Represent the team within broad cross-functional projects and oversee multiple project teams. - Independently mentor junior members on design and project deliverables. - Provide key contributions to the analytical and clinical studies in the program, including but not limited to protocol development, statistical analysis plans, and data reporting. - Contribute to the planning and delivery of key analytical or clinical components of regulatory submissions, including but not limited to Q-subs, PMA, and sPMA. - Represent Biostatistics in key regulatory meetings. - Develop innovative and creative statistical and technical solutions to complex problems. - Maintain statistics quality standards throughout the study process and statistical accuracy in all documents pertaining to the study. - Ensure statistical work is completed in accordance with established timeframes. - Track biostatistics activity deliverables. - Collaborate with laboratory scientists, technologists and the Regulatory team on study design, planning, data preparation, programming, analysis and presentation of results. - Draft study protocols and issue final reports on these studies. - Maintain availability to the wider FMI business for statistical interpretation and analysis. - Solicit feedback and communicate study results within FMI and to external stakeholders. - Other duties as assigned. - Comply with FMI's attendance policies. Qualifications - Master’s Degree in Statistics (or Biostatistics) and 7+ years of experience as a statistician in academia, biopharmaceutical, or diagnostics industry, academia, or FDA; OR, - PhD in Statistics (or Biostatistics) and 5+ year(s) of experience as a statistician in academia or in the biopharmaceutical or diagnostics industry, academia, or FDA. - Proficiency in statistical programming language R or SAS. Preferred Qualifications - Doctor of Philosophy in Biostatistics or Statistics. - 3+ years of experience as a statistician in academia or in the biopharmaceutical or diagnostics industry, or FDA. - Experience in time-to-event data analysis, cluster/longitudinal data analysis, clinical trials, random effect and measurement error models. - Experience in experimental study design and statistical methods in diagnostic medicine. - Extensive scientific understanding of cancer genetics and genomics. - Knowledge and experience with Next-Generation Sequencing (NGS). - Experience leading or managing a team of Biostatisticians. - Demonstrated leadership skills including proactive strategy setting, priority evaluations, conflict resolution, and effective partnerships. - Strong programming skills, technical proficiency and creativity. - Demonstrated history of independent thinking. - Demonstrated ability to meet project deadlines. - Demonstrated record of successful independent work and contributions to team projects. - Excellent communication, presentations and writing skills, and the ability to explain complex technical details in clear language. - High level of detail orientation with a focus on quality. - Ability to work well under pressure while maintaining a professional demeanor. - Understanding of HIPAA and the importance of patient data privacy. - Commitment to reflect FMI’s values: Integrity, Courage, and Passion. Salary and Benefits The expected salary range for this position based on the primary location of Remote is $145,000 - 179,000 per year. The salary range is commensurate with Foundation Medicines compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits. Company Description Foundation Medicine, Inc. (FMI) is a global, patient-focused precision medicine company delivering high-quality, transformative diagnostic solutions in cancer and other diseases. Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

View details: Senior Biostatistician

United States

$145K - $179K / year

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Clinical Claim Review RN

UnitedHealth Group

UnitedHealth Group is a healthcare and well-being company that’s dedicated to improving the health outcomes of millions around the world. We are comprised of

Clinical Research1 day ago

Full Time Remote Mid Level

Company Site

Role Description In this role, you'll be accountable for making decisions that directly impact our members while managing a demanding case load in a rapidly-changing, production-driven environment. - Perform clinical coverage review services, which require interpretation of state and federal mandates, applicable benefit language, and consideration of relevant clinical information. - Communicate all types of benefit determinations, including decisions regarding coverage guidelines, contractual limitations, and reimbursement determinations. - Speak with health care providers and/or members to explain benefit coverage determinations and obtain additional clinical information. Qualifications - Associate's degree - Current unrestricted RN license in the state of Massachusetts - 3+ years of experience as a RN, including experience in an inpatient/acute setting - 1+ years of clinical documentation experience - A designated homework space with access to install secure high-speed internet via cable/DSL Requirements - A background in utilization review for an insurance company or experience in case management (preferred) - Familiarity with Milliman Care Guidelines (preferred) - Critical thinking skills (soft skill) Benefits - Comprehensive benefits package - Incentive and recognition programs - Equity stock purchase - 401k contribution (all benefits are subject to eligibility requirements) - Hourly pay range: $29.00 to $52.00 per hour based on full-time employment

View details: Clinical Claim Review RN

United States

$29 - $52 / hour

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