Clinical Project Manager Salary in Saint Paul, MN

Job DetailsAre you passionate about improving the quality of healthcare? Are you ready to leverage your talents to make healthcare better for everyone? Do you want the opportunity to give back to your community? Do you want to have fun at work? Then join the growing team at Health Services Advisory Group (HSAG) that is transforming the delivery of healthcare in the United States!SummaryHSAG is nationally recognized as an industry leader in the areas of audits, data analysis, measure development, and patient satisfaction surveys. We are in search of talented individuals who are interested in a career in healthcare performance measure auditing as an Auditor, Sr. in HSAG's Audits department within the Data Science & Advanced Analytics division. Together we can spread positive change to make healthcare better. The Auditor, Sr. position benefits from HSAG's desire to grow its staff into future leaders of healthcare quality improvement in the nation. HSAG's auditors are provided formal training in an assortment of healthcare-related topics, including health policy, clinical concepts, overview of analytic methods, data sources, and management techniques. HSAG offers:A comfortable work-life balance, and flexible work schedules.Three weeks of paid time off and 15 company-paid holidays where staff leave two hours early prior to each holiday to get a "jump start" on holiday festivities.HSAG offers a competitive benefit package which includes medical, dental, vision, tuition reimbursement and 401(k).The Auditor, Sr. is a primary contributor to the Audit department's work that spans the broad spectrum of healthcare performance measurement projects at HSAG. Driven by intellectual curiosity and a passion for healthcare quality, this position performs-under supervision-healthcare auditing, data validation, and performance measurement projects through various stages including implementation, day-to-day operations, audit support, evaluation, and reporting. Activities include independently developing work plans, report templates, and timelines; independently leading contracts and project tasks; guiding coordination and Auditor I, II, and III staff in oversight and maintenance of project files and other project tasks; leading client teleconferences and meetings; performing online research on healthcare topics; leading performance measure validation audits; and providing regular progress reports to Data Science & Advanced Analytics management staff.Details regarding potential project assignments will be discussed with potential candidates during the interview process.Essential Competencies, Duties and ResponsibilitiesServe as a primary contributing member of HSAG's Audits department within DSAA.Serve as a lead auditor for all performance measure validation audits.Lead and manage multiple client contracts as primary point-of-contact and subject matter expert.Mentor and train junior staff with limited supervision.Provide oversight of supplemental Healthcare Effectiveness Data and Information Set (HEDIS®)[1] audit operations.Independently act in a liaison capacity between appropriate management personnel and staff, transmitting decisions and information to organizational units as appropriate, as well as outside agencies and organizations.Lead project management tasks, including communication (written, phone, fax).Communicate directly and manage project partners, consultants, subcontractors, and other entities on audit and performance measure validation-related projects.Maintain, tag, and sort documents for assigned projects on appropriate SharePoint team sites and HSAG's corporate and federal networks following HSAG prescribed governance rules.Prepare project deliverables and lead documentation and submission of deliverable using the appropriate mechanism (i.e., electronic, hard copy, direct data entry etc.).Develop and adhere to project time and task schedules, identify opportunities to improve the project process, and develop quality improvement activities accordingly.Meet agreed-upon deadlines in a timely fashion and independently and accurately prepare and type deliverables, reports, various project documents, letters, and other material.Lead and complete the development of written and data-oriented reports in Microsoft Word and Excel.Conduct research via the Internet including literature searches of clinical topics as assigned.Participate in and lead pertinent healthcare educational and training presentations as required.Conduct Internal Quality Control (IQC) monitoring regarding efficiency/effectiveness of activities conducted. Present issues and recommended solutions and take corrective actions as indicated.Serve as a subject matter expert to HSAG staff and clients on HEDIS measures and non-HEDIS performance measures as applicable.Represent HSAG in a professional manner at all times.[1] HEDIS Certified Measures® is a registered trademark of the National Committee for Quality Assurance (NCQA).Compensation: 101,000 to 125,000/annually DOEJob Requirements:Education and/or ExperienceMaster's degree in business, science, or healthcare-related field.At least seven years of work experience in healthcare and a minimum of ten years of work experience are required.Certified HEDIS Compliance Auditor (CHCA) required.At least five years of auditing experience and four years of experience as a lead auditor; at least four years in HEDIS auditing and/or data validation, with at least one year as a lead are required.Advanced knowledge of performance measures is required.Experience writing client reports as a lead author and report designer is required.Prior experience leading multiple medium and large projects or contracts is required.Experience writing responses to requests for proposals is required.At least two years of supervisory experience, including experience mentoring junior staff.Other QualificationsProficient English/communication skills (i.e., public speaking, spelling, composition, grammar, proofreading and editing).Proficient interpersonal skills.Experience in Microsoft Word, PowerPoint, and Outlook.Experience in Microsoft Excel.Experience in conducting research via the Internet.Ability to handle several projects simultaneously and work with multiple teams.Work EnvironmentThe work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.HSAG All User Information Security ResponsibilitiesAll workforce members, volunteers, contractors or third-party agents of HSAG, Inc. who are authorized to access information systems and/or associated company data on paper or in electronic format are responsible for the following:Adhering to policies, procedures and guidelines pertaining to the protection of HSAG Company Data.Reporting actual or suspected breaches or vulnerabilities in the confidentiality, integrity or availability of HSAG Data to your immediate supervisor/manager, Corporate Compliance or Information Technology/Security Personnel.Reporting actual or suspected breaches or vulnerabilities in confidentiality, integrity or availability of Corporate Data, may be reported anonymously, via the NAVEX Global Compliance hotline at 1-800-992-9892.HSAG publishes various policies, guidelines and procedures related to the protection of Corporate Data and Information Systems. They can be found on the corporate SharePoint website. Information on requirements that may be unique to your business unit or a system you have access to can be found by talking to your supervisor/manager or designated system administrator.DisclaimerThis is not necessarily an exhaustive list of all responsibilities, skills, duties, requirements, efforts or working conditions associated with the position. While this is intended to be an accurate reflection of the current position, management reserves the right to revise the position or to require that other or different tasks be performed when circumstances change (e.g., emergencies, changes in personnel, workload, rush jobs requiring non-regular work hours, or technological developments).HSAG is an EEO Employer of Veterans protected under Section 4212.If you have special needs and require assistance completing our employment application process, please feel free to contact us. 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ResponsibilitiesReviews and validates CRO deliverablesOversees programming-related activities performed by CROSupports and manages regulatory compliant Clinical Data Repository and biometrics programming environmentWrites or reviews SAS programs to implement statistical analyses (i.e., generating tables, listings, figures, and inferential statistical outputs) supporting regulatory requests, IB/DSUR/PBRER analyses, ISS/ISE analyses, medical affairs requests, ad-hoc analyses and moreSupports or oversees creation of SAS utility macros; writes and implements test plans to support SAS macro development as neededPerforms quality review on SAS programs generated by other statistical programmers and biostatisticiansFollows good programming practices and adequately document programsAttends project team meetings, works with vendors, biostatisticians, data managers, and clinical research managers, as appropriateUnderstands and follows FDA regulations including good clinical practice and guidelines for electronic submissionsLeads the development of data collection, analysis and reporting standards and processesProvides mentorship and support to junior level programmersQualificationsB.A. / B.S. with 7+ years relevant experience or an M.S. with 5+ years' experienceExperience working on NDA/BLA/MAA development and submissionsExcellent knowledge of SAS, including SAS macro language and procedures (e.g., PROC FREQ, PROC REPORT, PROC GLM)Experience managing a CROExcellent knowledge of pharmaceutical standard initiatives such as CDISC, ADAM, SDTM, and CDASHStrong organizational skills, attention to detail and the ability to learn technical and clinical aspects of a clinical trialKnowledge of medical and statistical terminologyBeacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records. Company Profile:Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.Learn more about Beacon Hill Staffing Group and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.beaconhillstaffing.com . We look forward to working with you!Beacon Hill. Employing the Future™

(W2 ONLY, with benefits)MDR- MDR/Vigilance Specialist (24-Month Contract in Mounds View, MN):Work Location: Hybrid - M/T/F virtual; W/Th in office in Mounds View, MNTop 3 things the hiring manager is looking for: Previous experience with Legal activities, preferably holding a JDAlso open to candidates coming from a Regulatory or Healthcare background. Ideally seeking candidates capable of easily interpreting and effectively communicating requirements for various standards and regulationsAnalytical reading/writing, with excellent communication skillsStrong attention to detailTop 3 Tasks or Responsibilities in scope for this role: Electronically process eventsPerform tasks to obtain adequate information for proper documentation and closure of the eventCollaborate with technical, clinical, field, and other client employees to determine reportabilityDescription:In the MDR- MDR/Vigilance position you will participate in the company's medical device surveillance platform, including the intake, evaluation, processing, and follow-up on product performance events, complaints, and adverse reports. The MDR/Vigilance Specialist analyzes events reported from multiple inputs on Cardiovascular products to determine complaint status and regulatory reportability. In addition, this position supports the ongoing monitoring of product performance. Works cross-functionally to ensure maintenance and review of events and reporting of regulatory reports, as set forth by the FDA and other regulatory agencies. This process is governed by the FDA Quality System Regulations (QSR) Guidelines, ISO 13485:2003, Good Manufacturing Practices (GMPs), and proper complaint handling per the Code of Federal Register (CFR) and other governmental regulations. Requires follow-up internally and externally to assure complete and accurate event files, complaint detail, and product performance information. Supports and represents complaint handling in internal and external audits and inspections.As part of the Cardiovascular Customer Quality Product Experience Management organization, we seek candidates who will meet our customer expectations by striving without reserve for the greatest possible reliability and quality in our products, processes, and systems by being accountable, having a voice, and taking action. This position requires the individual to be a main contributor to product quality improvement efforts and be the main contact to our customers on complaint issues. Client Business Unit: Our Cardiac Rhythm Management Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure. We are comprised of three key businesses: Cardiac Pacing Therapies, Cardiovascular Diagnostics & Services, and Defibrillation Solutions. Duties:Electronically process events to determine complaint and reportability status. Complete applicable Medical Device Reports (MDR) as required per internal policy & procedures and FDA regulations.Ensure complaint investigations are adequate, accurate, detailed, and timely.Perform tasks to obtain adequate information to ensure proper documentation and closure of each complaint. Collaborate with appropriate technical, Clinical, Field/Sales and/or returned product analysis employees to determine reporting eligibility. Complete electronic submission of MDRs to the FDA. Ensure accurate data entry, scanning, and retention of documents to complete event files.Support internal systems, methods, and procedures to maintain compliance. Develop and maintain product knowledge of CRHF products.Assist in inspection support for FDA and global regulatory agencies. This may include research and preparation of correspondence in response to global regulatory agencies requests for additional information. Develop and maintain a working knowledge of regulations and standards related to post-market quality & complaint handling. Complete projects as assigned and required specific to post-market quality and complaint handling. Minimum QualificationsRequires a Bachelor's Degree and 2-4 years of relevant experience, or advanced degree with 1+ years of experience.Preferred Qualifications: Previous Medical Device Reporting experienceKnowledge of EU MDR requirementsExperience working with Cardiac/Rhythm and Heart Failure devices