Clinical Project Manager
Location
Michigan + 39 moreAll locations: Michigan | Indiana | Kentucky | Tennessee | Georgia | Florida | Ohio | North Carolina | South Carolina | West Virginia | Virginia | Pennsylvania | District Of Columbia | Connecticut | New Jersey | New York | Rhode Island | New Hampshire | Maine | Maryland | Delaware | Vermont | Massachusetts | North Dakota | South Dakota | Nebraska | Kansas | Oklahoma | Texas | Minnesota | Iowa | Missouri | Arkansas | Louisiana | Wisconsin | Illinois | Mississippi | Alabama | EST (UTC-5) | CST (UTC-6)
Posted
17 days ago
Salary
0
Seniority
Lead
No structured requirement data.
Job Description
Clinical Project Manager
CoMind
Role Description This job is based remotely in the US, but you should be based in an Eastern or Central Time zone. At CoMind, we are developing a non-invasive neuromonitoring technology that will result in a new era of clinical brain monitoring. In joining us, you will be helping to create cutting-edge technologies that will improve how we diagnose and treat brain disorders, ultimately improving and saving the lives of patients across the world. The Clinical Team leads the deployment of CoMind's technology into hospital environments for the first time, managing clinical sites, supporting device installations, and ensuring the smooth execution of clinical studies in partnership with clinicians. As Clinical Project Manager, you will own the planning, execution, and oversight of assigned clinical studies, working cross-functionally with clinical operations, regulatory, data science, and investigator sites to ensure studies are delivered on time, within budget, and in full compliance with applicable regulations. Please note that this role will require approximately 20% travel, depending on study needs. - Develop and maintain clinical project plans, timelines, and budgets; lead site feasibility assessments, selection, and CTA negotiations for assigned studies - Prepare and review key study documents including protocols, ICFs, CRFs, and study manuals in accordance with ISO 14155, FDA/ICH guidelines, and CoMind SOPs - Oversee site initiation, monitoring, and close-out visits, ensuring protocol adherence and data quality; track enrollment and KPIs and proactively mitigate risks to study timelines - Review monitoring reports and drive timely resolution of site issues, deviations, and CAPA activities - Manage clinical data activities including CRF completion, query resolution, and data cleaning in collaboration with data management - Ensure study conduct compliance with 21 CFR Parts 812, 50/56, ISO 14155, and GCP; support internal and external audits and FDA inspections as required - Author and review clinical study reports, periodic safety reports, and clinical evaluation reports; provide regular study status updates to senior management and cross-functional stakeholders AI is fundamental to our culture -- it's not just a tool, but a core part of how we work, collaborate, and innovate. We expect all team members to embrace AI in their daily work and continuously find new ways to use it effectively. Qualifications - 3-6 years of clinical research experience, with at least 2 years in medical device clinical trials - Demonstrated knowledge of FDA regulations (21 CFR 812), ISO 14155, and GCP guidelines - Hands-on experience managing clinical sites and/or CRO relationships - Proficiency with EDC, eTMF, CTMS, and standard office software - Strong communication, organisational, and documentation skills with the ability to manage multiple studies simultaneously Nice to have - Familiarity with neurology, neurocritical care, TBI, or ICU-based clinical settings - Experience authoring or contributing to clinical study reports or clinical evaluation reports Benefits - Company equity plan - Annual Unlimited PTO - Health insurance plan - CoMind contributes 50% to the monthly premium (with the Blue Cross Network) - Dental insurance (50% Employer Contributions to individual policy) - Vision insurance (50% Employer Contributions to individual policy) - 401k plan with an employer match up to 3% - Mental health resources
Related Guides
Related Categories
Related Job Pages
More Clinical Operations Jobs
• Lead the initiation, maintenance and close out activities of multi-center studies in accordance with the protocol, relevant SOPs, Good Clinical Practice, international standards, and regulatory requirements • Plan and procure team resources as needed to complete study activities according to scope, budget, and timeline • Develop and/or oversee development of study plans such as project management (including communication), monitoring, risk management, data management and safety plans • Coordinate activities with central laboratories and other external service providers/vendors • Review and negotiate site budgets and contracts • Initiate and participate in the development of change orders to sponsor and/or site contracts and budgets • Maintain appropriate and effective communication with sponsor, external service providers, and other internal departments to ensure successful project completion
Director, Clinical Operations – Lung Program
4D Molecular TherapeuticsPowering the Future of Genetic Medicines
• Provide strategic and operational leadership for global clinical trial execution across the 4DMT lung portfolio. • Responsible for delivering clinical programs aligned with corporate timelines, budget, quality, and regulatory expectations. • Lead internal Clinical Operations teams and external partners/CROs. • Collaborate with external teams to ensure efficient, high-quality, inspection-ready execution of Phase 1–3 clinical studies. • Serve as a key cross-functional leader and Clinical Operations subject matter expert.
Role Description The Clinical Staff Pharmacist provides direct patient care related to medication prescribing, administration, and monitoring for patients of Carle Foundation Hospital. This individual also participates in decentralized care and focused drug studies, and will provide clinical expertise to assist the other staff pharmacists in completion of their duties. Qualifications - Certifications: Licensed Pharmacist - Illinois Department of Financial and Professional Regulation (IDFPR) - Education: Doctorate in Pharmacy - Experience In Lieu of Education: Work Experience in Pharmacy Requirements - Assist in focused studies and drug usage evaluations as assigned. - Assist in the development of clinical guidelines and order sets as related to appropriate drug therapy. - Participate in decentralized care interacting with physician groups such as family practice, hospitalists, and critical care. - Provide direct patient care by intervening as appropriate to improve prescribing, administration, and monitoring practices in the facility as related to medications. - Represent the pharmacy on committees or work groups as assigned. - Interpret physician medication orders and send the appropriate medication in a timely and accurate manner. - Screen medication orders for potential interactions with other medications, diet orders, disease state, or stated allergies. - Supervise the technicians in the preparation and dispensing of medications and parenterals. - Make dose recommendations based on age, weight and clearance function. - Assist in the training and orientation of all new employees as assigned. - Provide accurate and complete accounting of all controlled substances. - Provide Medication Therapy Management Services as defined in the Illinois Pharmacy Practice Act. - Perform utilization management reviews. - Serve as drug information resource for other departments. - Conduct medication reconciliation, perform clinical interventions, uncover adverse drug reactions, and refer patients to pertinent clinics (i.e. anticoagulation). Benefits - The compensation range for this position is $52.06 per hour - $89.54 per hour. - Actual compensation offered will depend on factors including experience, qualifications, location, training, licenses, shifts worked, and compensation model. - Comprehensive benefits package for team members and providers.
Clinical Project Lead, Oncology
IQVIAIQVIA is a publicly-traded healthcare intelligence company founded in 2016 upon the merger of two market leaders: Quintiles and IMS Health. With locations aroun
Title: Clinical Project Lead, Oncology Location: Philadelphia United States Job Description: In this remote role you will serve as the primary country-level leader for clinical trial delivery, ensuring studies are executed efficiently from start-up through closeout. You will oversee local trial operations, drive performance, and collaborate cross-functionally to deliver high-quality data aligned with regulatory requirements and sponsor expectations. This role is ideal for a clinical operations professional who thrives in a fast-paced, large matrixed environment and is passionate about improving patient outcomes through clinical research. Key Responsibilities Clinical Trial Delivery & Oversight - Lead end-to-end country-level trial management, from study start-up through database lock and closeout - Serve as the primary contact for assigned clinical trials within your country - Ensure delivery of high-quality, compliant data and documentation aligned with ICH-GCP, SOPs, and regulatory standards - Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target Site & Stakeholder Management - Partner with CRA's, Global Project Leads, and cross-functional teams to ensure successful study execution - Lead site feasibility, selection, and activation processes - Drive investigator engagement and site performance, including recruitment and retention strategies Operational Excellence & Compliance - Monitor study progress through systems and reports; implement corrective and preventive actions (CAPA) when needed - Ensure inspection readiness through complete and accurate trial documentation (CTMS, eTMF) - Oversee patient safety reporting (AEs/SAEs) within required timelines Financial & Vendor Management - Manage country-level budgets, forecasting, and financial tracking - Oversee local vendors and site payments, ensuring timely and accurate processing Regulatory & Quality Assurance - Coordinate ethics and regulatory submissions/approvals in collaboration with start-up teams - Ensure compliance with local regulations and global standards (ICH-GCP) What You Bring Required Qualifications - Bachelor's degree in life sciences, healthcare, or related field - Strong knowledge of ICH-GCP, regulatory requirements, and clinical trial processes - Excellent communication and stakeholder management skills - Proficiency in clinical systems (e.g., CTMS, eTMF) - 3-5+ years of total trial management experience - Experience managing complex or early-phase trials - Demonstrated ability to lead cross-functional teams and drive performance IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. The potential base pay range for this role, when annualized, is $68,400.00 - $232,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.



