• Full accountability for country-level study delivery and performance • Serve as the client’s voice within Civia, ensuring their priorities, timelines, and standards are understood and met across all functions • Maintain disciplined oversight of start-up, recruitment, regulatory progress, data quality, and site performance • Drive immediate cross-functional action when performance deviates from plan • Lead structured governance routines with clarity, transparency, and solution orientation • Ensure ongoing audit and inspection readiness across all study activities

Role Description As a member of the Clinical Services team, the Utilization Management Inpatient (UM IP) Clinical Specialist receives, researches, and takes action related to documentation and requests from various sources related to Inpatient Utilization Management cases. The UM IP Clinical Specialist partners with licensed health professionals on appropriate actions and responses to support efficient and effective clinical reviews. - Utilize clinical knowledge and critical thinking to research and review IP UM requests. - Communicate effectively with internal and external stakeholders, including providers and team members. - Exhibit excellent time management skills to ensure timeliness of UM activities. - Organize and maintain reference documents, policies, and procedures. - Perform detailed research and problem-solve using sound decision-making skills. - Initiate referrals to adjacent teams as needed. - Discuss discharge planning with providers as needed. Qualifications - High school diploma or equivalent. - Clinical experience is required. - At least 2 years of clinical experience preferred. - CMA or CNA preferred. - Strong communication skills, both oral and written. - Computer skills, including Microsoft Office, Outlook, and internet search. - Knowledge of medical terminology, anatomy, and coding (CPT, DX, HCPCs). Requirements - Ability to work independently with a high volume case load. - Prioritize tasks, meet deadlines, and achieve operational standards. - Maintain confidentiality and focus on meeting customer needs. - Adapt to changes in the healthcare insurance industry. - Utilize strong organization, data entry, and administrative skills. Benefits - Medical, dental, and vision coverage for employees and their eligible family members, including mental health benefits. - Annual employer contribution to a health savings account. - Generous paid time off varying by role and tenure in addition to 10 company-paid holidays. - Market-leading retirement plan including a company match on employee 401(k) contributions. - Up to 12 weeks of paid parental time off (eligibility requires 12 months of continuous service). - Award-winning wellness programs that reward participation. - Employee Assistance Fund for those in need. - Commute and parking benefits.

Role Description Our team is actively recruiting for a Clinical Specialist I, CPT in Minneapolis, MN. As a member of the clinical support team, you will be responsible for providing technical clinical expertise and support of the sales process to colleagues, current customers, and/or potential customers. You will work under general direction with clinical and sales teammates to identify and capitalize on sales opportunities. - Provides technical, clinical, and programming assistance, primarily in support of 1-2 Territory Manager(s). - Assists Territory Managers in after-hours call support and activities. - Integrates into all accounts, builds trust and relationships, and establishes strong rapport with customers. - Proficient in complex programming and case support. - Works seamlessly with Territory Manager(s) allowing them increased selling time. - Fosters high trust relationships with customers, including regional team members. - Conducts PCP work and educational in-services, as directed. - Contacts, visits, and engages clients and potential clients regarding the Company’s products and addresses any client questions and concerns. - Provides medical professionals with sales support, information, and training on the use of Company products. - Develops and maintains an in-depth knowledge of assigned accounts and customers to include competitor activity. - Conducts evaluations and develops sales strategies for capital equipment opportunities within accounts. - Collects and studies information about new and existing products and monitors competitor sales, prices, and products. - Provides feedback to providers on the directions for use specific to implantable devices. - May attend trade shows and conferences to meet other sales representatives and clients. - Uses clinical expertise to identify customer training and in-service needs. - Complies with U.S. Food and Drug Administration (FDA) regulations and other regulatory requirements. - Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. - Performs other related duties and responsibilities, as assigned. - Ability to travel 25% within assigned region and/or outside assigned region. Qualifications - Associates Degree or technical certification; preferred Bachelor’s Degree. - 1 - 2 years’ work experience, strong preference collaborating with patients in clinical setting. - The ability to communicate, understand and educate clinical data in the Chronic Pain Therapies space. - Strong clinical skills. - Excellent organizational, time management, and prioritizing skills. - Excellent interpersonal verbal, written, and presentation skills. - Capable of building strong working relationships with internal/external customers. - Capable of working unpredictable schedule that may occasionally change on short notice. - Accustomed to tight deadlines and managing multiple tasks. - Strong sense of urgency. - Ability to work in a highly matrixed and geographically diverse business environment. - Ability to work within a team and as an individual contributor in a fast-paced, changing environment. - Strong verbal and written communications. - Multitasks, prioritizes, and meets deadlines in a timely manner. - Capable of engaging customers in selling conversations as needed. Requirements - Patient interaction experience within health care related environment (Physical Therapy, medical product sales, RN, LPN). - Experience working in a broader enterprise/cross-division business unit model preferred. - 1-3 years’ experience with Abbott, or in similar spinal cord stimulation (SCS) setting or with another implantable medical device company. Benefits - Career development with an international company. - Free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. - An excellent retirement savings plan with high employer contribution. - Tuition reimbursement and educational benefits. - A company recognized as a great place to work in dozens of countries. - A company recognized as one of the best big companies to work for and for diversity.

Role Description The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. Key Accountabilities - Contributes to the selection of potential investigators. - Accountable for study start-up and regulatory maintenance, including: - Site Qualification Visits - Collection, preparation, review, and tracking of documents for the application process - Submission of proper application/documents to EC/IRB and Regulatory Authorities - Trains, supports, and advises Investigators and site staff in study-related matters, including Risk Based Quality Management (RbQM) principles. - Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training. - Ensures the sites are inspection ready at all times. - Actively participates in Local Study Team (LST) meetings. - Contributes to National Investigators meetings, as applicable. - Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. - Drives performance at the sites and ensures timely resolution to study-related issues. - Updates CTMS and other systems with data from study sites as per required timelines. - Manages study supplies and drug accountability at study site. - Performs monitoring visits (remote and onsite) in accordance with the Monitoring Plan. - Performs Source Data Review (SDR), Case Report Form (CRF) review, and Source Data Verification (SDV). - Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly. - Ensures data query resolution in a timely manner. - Works with data management to ensure robust quality of the collected study data. - Ensures accurate and timely reporting of Serious Adverse Events and their follow-ups. - Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator. - Follows up on outstanding actions with study sites. - Escalates systematic or serious quality issues as required. - Assists site in maintaining inspection ready ISF. - Prepares for and collaborates with activities associated with audits and regulatory inspections. - Ensures timely collection/uploading of essential documents into the eTMF. - Supports/participates in regular QC checks performed by LSAD or delegate. - Ensures all study documents are available and ready for final archiving. - Provides feedback on any research-related information that might be useful for the local market. - Collaborates with local Medical Science Liaisons (MSLs) as directed. Qualifications - Excellent attention to detail. - Good written and verbal communication skills. - Good collaboration and interpersonal skills. - Good negotiation skills. - Proficient in written and spoken English language required. - Fluency in local language(s) required. Requirements - Ability to work in an environment of remote collaborators. - Manages change with a positive approach. - Ability to look for and champion more efficient methods of delivering quality clinical trials. - Good analytical and problem-solving skills. - Demonstrates ability to prioritize and manage multiple tasks. - Ability to understand the impact of technology on projects. - Team oriented and flexible; ability to respond quickly to shifting demands. Knowledge and Experience - Excellent knowledge of international guidelines ICH-GCP. - Good knowledge of relevant local regulations. - Good medical knowledge and ability to learn relevant Client Therapeutic Areas. - Basic understanding of the drug development process. - Good understanding of Clinical Study Management. Education - Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification. Other - Ability to travel nationally/internationally as required. - Valid driving license per country requirements, as applicable. Company Description