Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is seeking a Clinical Project Manager II to partner with one of our sponsors in leading a clinical sleep study. This role requires demonstrated experience managing medical device clinical trials, with a strong preference for respiratory study experience. The ideal candidate will bring expertise in overseeing study execution, ensuring regulatory compliance, and driving cross-functional collaboration to deliver high-quality results on time and within scope. This is a remote W-2 position on a one-year contract. ClinChoice is a global full-service CRO with a strong focus on quality and professional development. As a client-facing role, we are looking for confident candidates with the ability to work independently while establishing a high-trust environment with their client counterparts. Main Job Tasks and Responsibilities: - Manages the delivery of study requirements to the protocol and regulations such as GCP and ISO 14155, the site needs and the required timelines set for the project. - Apply principles, concepts and techniques for effective and proactive project management of a clinical study. - Balances resource constraints (i.e. time, money, people, and equipment) against deliverables. - Develop clinical study budget and may assist in quarterly departmental budget reviews. - Seeks input from higher-level clinical experts or program management as issues warrant. - Leverage experience and work with collaborative team members to recommend and implement methods for improving processes and addressing issues within the clinical operations department. - Implement and maintain risk-based monitoring processes to drive efficient and effective study management. - Oversee and review data and/or monitoring reports for protocol violations and serious protocol deviations, and proactively address violations/deviations, to assure protocol and GCP compliance. - Train and mentor more junior staff on monitoring, internal procedures, and query resolution to assure alignment and GCP compliance. Education, Experience and Skills: - Bachelor's or advanced degree in a relevant scientific discipline. - 3-5 years of medical device clinical project management experience. - Experience with sleep and respiratory studies are required. - In-depth knowledge of ICH-GCP, EMEA guidelines and other relevant regulations and guidelines. - Proven ability to manage clinical studies within timelines and budgets while maintaining high quality standards and patient safety. - Ability to proactively develop risk management and mitigation plans in country and resolve issues locally. - Effective and efficient time management, organizational and interpersonal skills, conflict management and problem-solving skills. - High sense of accountability and urgency to prioritize deliverables. - Strong communication skills and negotiation skills as well as excellent influencing and training/mentoring, both written and verbal. - Ability to focus on multiple deliverables and protocols simultaneously is essential. - Positive mindset, growth mindset, capable of working independently and being self-driven. - Able to directly influence Clinical Operations staff. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical devices, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built, and close management and training is the core instrument to develop and maintain highly-qualified personnel. Continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. Key Words: Clinical Study Management, Clinical Project Management, Clinical Operations, Study Delivery, Protocol Compliance, GCP (Good Clinical Practice), ISO 14155, Risk-Based Monitoring (RBM), Study Timelines, Resource Management, Budget Development, Budget Oversight, Clinical Study Budgeting, Protocol Deviations, Serious Adverse Events (SAE) Oversight, Regulatory Compliance, Audit Readiness, Monitoring Reports Review, Data Review & Oversight, Quality Assurance, Inspection Preparedness, Cross-Functional Collaboration, Site Management, Monitoring Oversight, Query Resolution, Risk Management, Vendor Management, Study Start-Up & Close-Out, Clinical Trial Lifecycle Management, Medical Devices, Respiratory, Sleep Studies #LI-VH #LI-Remote #Project Manager # Contract

Our Client, a global pharmaceutical company, is looking for a Clinical Project Manager who will own the full lifecycle of a sample distribution program, ensuring that all phases from design through delivery are executed on schedule and in compliance with regulatory requirements. This includes developing and maintaining SOPs and PDMA compliance documentation, coordinating the technical implementation of sample-tracking tools in the CRM system, and training the field sales team on proper sampling procedures. The candidate will act as the primary liaison between the client, salesforce presenting project updates and reports. This is a remote, contractual position, that goes until the end of September 2026, with the likelihood of extension. Candidate's applying for this role must be located in the EST or CST time zones of the USA. Key Responsibilities - Oversee the entire physician sampling initiative from defining processes and launching new sample offerings to ongoing distribution and reconciliation. This involves managing logistics and inventory, tracking sample usage, and closing the loop on returned or expired samples. - Oversee coordination between clinical operations, medical affairs, and commercial teams to ensure that sampling programs align with clinical guidelines, therapeutic protocols, and product lifecycle strategies. - Collaborate with clinical data management and medical affairs teams to ensure that any clinical data or insights related to physician sampling programs are properly captured, documented, and aligned with regulatory requirements. - Work with clinical stakeholders and regulatory teams to support audit readiness, ensuring all documentation and sampling processes meet clinical trial support standards and healthcare compliance expectations. - Support cross-functional initiatives between clinical operations, regulatory affairs, and commercial teams when sampling activities relate to product launches, clinical education programs, or therapeutic area expansion. - Contribute to clinical process improvement initiatives, ensuring that digital tools, CRM workflows, and operational processes support both commercial sampling activities and broader clinical engagement strategies. - Draft, update and enforce SOPs and compliance materials (PDMA submission packages, FDA/21 CFR compliance documents, etc.) for all sampling activities. Ensure the program adheres to federal regulations and company policies. - Work closely with IT and technical teams to implement or upgrade the CRM’s sample-tracking module (e.g. Veeva or Salesforce). Validate system configuration, manage user acceptance testing, and ensure the CRM supports audit trails and reporting requirements. - Design and deliver training programs for the sales field team on sampling SOPs and PDMA compliance. Develop training materials and metrics, spearheaded the development of training initiatives that improved compliance to ensure sales reps understand proper procedures and documentation. - Serve as the main point of contact for client teams and physician offices. - Track program performance and prepare regular reports (e.g., monthly/quarterly summaries of sample distribution, inventory levels, and compliance KPIs). Requirements - 4-5 years’ experience managing pharmaceutical or sales support programs. Demonstrated ability to run a full sample program “from end to end”, including inventory management and sample accounting. - Solid knowledge of FDA/PDMA regulations for drug samples. Proven skill in writing and maintaining SOPs and compliance documents for projects. - Hands-on experience with CRM platforms (e.g. Salesforce, Veeva). - Ability to coordinate with IT and vendors on system configuration and data integration. - Background in pharma or biotech environments, especially commercial operations (sales, marketing, compliance). - Experience working in pharmaceutical, biotech, or clinical research environments, with exposure to clinical operations, medical affairs, or regulatory processes. - Understanding of clinical governance frameworks such as GxP (GCP, GVP, or GMP) and their interaction with commercial and physician engagement programs. - Experience collaborating with clinical stakeholders, regulatory teams, or medical affairs to ensure compliance and operational alignment. - Familiarity with clinical documentation standards, audit preparation, and healthcare regulatory oversight. Preferred Qualifications - Experience with sample distribution software or electronic sample closets (e.g. Deploy, SampleIQ) and digital sampling strategies. - MBA or advanced degree in life sciences/pharmacy; PMP or Six Sigma/Lean certification. - Exposure to clinical systems integration, including collaboration between CRM platforms and clinical data systems. - Experience supporting clinical-commercial hybrid programs, such as physician education initiatives, product launch support, or clinical engagement tracking. - Background working in regulated healthcare environments where clinical, compliance, and commercial processes intersect.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description As the Clinical Technology Trainer, the primary focus is to ensure Marathon providers and clinical teammates have the training and support they need to optimize their use of Marathon's electronic health record (EHR) and supporting clinical applications. - Conduct workflow analysis, application optimization, training, communications, and ongoing support. - Contribute to ensuring the effective and efficient use of clinical systems to achieve clinical goals, high quality outcomes, and maximize teammate satisfaction. Essential Duties & Responsibilities - Provides clinical IT system training and support for newly onboarding clinics and new hires. - Completes training, implementation, testing, and support of clinical applications including, but not limited to, eClinicalWorks, Salesforce, Rubicon, Up to Date, Dragon, and other office automation products used by providers and clinical staff. - Ensures clinical workflows, data management, and integration processes are implemented to support reliable, accurate, scalable, and timely reporting to all internal and external stakeholders. - Supports standardization and delivers a consistent approach relating to the implementation and training of new clinics and teammates. - Provides support for eClinicalWorks and clinical system upgrades and new implementations. - Supports and promotes systems standardization, utilization, and best practices in clinical information technology. - Promotes system security, patient confidentiality, and helps ensure compliance with applicable laws and regulations (i.e., HIPAA). - Assists in designing and delivering training and development programs based on both enterprise and individual needs. - Monitors and reviews the progress of clinical teammates, assesses training effectiveness, identifies improvement opportunities, and implements changes to the training program. - Trains and supports the development of “super users” of clinical information technology and related capabilities. - Represents Marathon to the medical community and clinic staff and serves as an advocate in promoting the use of information technology in the clinical setting. - Works in concert with the Vice President, Clinical Technology, and key stakeholders to gain feedback from the clinic teams. - Serves as an enterprise subject matter expert (SME) on EHR and other clinical support systems. - Successfully works and resolves Help Desk Tickets as required and as it relates to EHR and other clinical support systems as assigned. - Participates in special projects as needed and performs other duties as assigned. Qualifications - Bachelor’s degree plus a minimum of 3 years of training experience in a Health Care related field, preferably Electronic Health Records. - 2+ years of experience working with EHR systems and clinical technologies (eClinicalWorks experience preferred) or equivalent combination of education and experience. Desired Attributes - Skilled at providing high quality support to Marathon teammates with a high degree of customer service, technical expertise, timeliness, and professionalism. - Good working knowledge of healthcare, in particular physician practice and clinic workflows, IT systems, and facilities. - Working knowledge of privacy and security standards (e.g., HIPAA). - Proficient in Microsoft Products- Word, Excel, PowerPoint, and Visio, preferred. Pay Range $65,000 - $85,000/yr. The actual offer may vary dependent upon geographic location and the candidate’s years of experience and/or skill level.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Associate, Senior Associate, Manager – Clinical Trial Imaging Operations Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position can change over time and can include additional responsibilities not specifically described in the job description. - Serve as the primary escalation point for assigned clinical trials, projects, and programs, ensuring timely resolution of imaging-related issues. - Monitor imaging activities at clinical trial sites and approved imaging centers to ensure timely and high-quality deliverables. - Leverage tools, data, and cross-functional resources to support informed decision-making and foster collaboration with global clinical trial teams and sites. - Partner with internal teams and external partners to ensure consistent, high-quality engagement across study teams and global sites. - Coordinate and track local, regional, and global imaging deliverables, including issue identification, contingency planning, and resolution. - Develop and implement risk mitigation plans to support enrollment targets and database lock timelines. - Partner with internal and external stakeholders to remove operational barriers and enable successful trial execution at site and country levels. - Apply project management and clinical trial expertise to align imaging deliverables with scope, timelines, and budget. - Lead onboarding and oversight of Third-Party Organizations (TPOs), ensuring adherence to performance metrics and budget compliance. - Coordinate operational aspects of imaging trials, including protocol development, imaging plan execution, staff training, and documentation. - Manage relationships with imaging centers, triage technical support for image acquisition, reconstruction, troubleshooting, and data transfer. - Collaborate cross-functionally to maintain project timelines from planning through completion, with a focus on imaging data collection and analysis. - Proactively identify and escalate risks and barriers, coordinating mitigation strategies to maintain project momentum. - Continuously evaluate team activities and processes to propose alternate solutions and process improvements. - Perform other duties as assigned Minimum Qualification Requirements: - Bachelor’s degree or equivalent experience (scientific or health-related field preferred) - 2+ years clinical research experience or relevant clinical experience in a scientific or health-related field Additional Skills/Preferences: - Understanding of Good Clinical Practice principles - Clinical research experience, preferably in pharmaceutical development or a clinical research organization - Experience in nuclear medicine or radiopharmaceuticals - Applied knowledge of trial execution methodology, processes, and tools - Demonstrated strong teamwork and collaboration skills and the ability to work cross-culturally with global colleagues and Third-Party Organizations - Effective and influential communication, self-management, and organizational skills - Demonstrated ability to manage complex situations through problem-solving, critical thinking and navigating ambiguity - Flexibility to adjust to altered priorities - Proficient with Microsoft Outlook, Word, Excel, Teams, Planner, and PowerPoint. - Consistent, successful demonstration of project management behaviors with excellent oral and written communication skills; able to communicate clearly and succinctly with team members; reflects and committed to Team Lilly’s values. - Overnight travel may be required and is estimated at 10% - Position location: Remote or Philadelphia Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is $65,250 - $161,700 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly