The Senior Clinical Data Manager provides clinical data expertise to project teams in an outsourced and/or insourced Clinical Data Management model. The successful candidate will have advanced knowledge of end-to-end clinical research lifecycle and Clinical Data Management processes, as well as global regulatory, and industry rules and guidance (i.e. ICH, GCP) to support drug or biologics development. This role is responsible for managing Data Management components of projects, including vendor performance for outsourced projects. This position may mentor Clinical Data Management team members and may direct activities of Arcus Clinical Data Management vendors. The incumbent may contribute to department initiatives and non-study projects.
Responsibilities
Support all Data Management activities for assigned projects, including outsourced and/or insourced models.
May act as the Lead Data Manager or Support Data Manager on insourced studies and act as Oversight Data Management Lead or support for outsourced studies.
Actively participate on cross functional teams as the Data Management subject matter expert. This includes providing accurate Data Management updates and timelines during each stage of the study lifecycle, proactive communication for all Data Management topics, and complex risk assessment and mitigation planning with a firm awareness of cross functional impact.
Lead and/or support Data Management start-up activities, such as development and review of protocols, EDC database development documentation and activities, eCRF Completion Guidelines, Data Management Plans, and cross functional collaboration.
Ensure data collected in the clinical and vendor databases meets the requirements for analysis, including development and maintenance of Data Transfer Agreements and vendor data transfer workflow.
Participate in all aspects of data cleaning and review, including routine data cleaning, third party data reconciliation, query management, metrics reporting, and cross functional data health communication and documentation.
Review and contribute to cross functional study documents, such as Protocols, Clinical Monitoring Plans, Statistical Analysis Plans, Safety Monitoring Plans, and presentation slide decks.
Maintain all Data Management documentation, ensuring preparedness for regulatory inspections.
Collaborate with internal and external stake holders for data transfers and data analytics activities.
May develop, review, and revise SOPs, Work Instructions, and Templates
Requirements
Bachelor’s Degree, or commensurate experience, with at least 4 years’ experience in Clinical Data Management with a Pharmaceutical, Biotech, CRO, or Academic Center. Oncology preferred.
Excellent verbal and written communication skills. Ability to communicate Data Management and EDC technical concepts to cross functional groups for awareness and understanding.
Highly organized, collaborative, detail-oriented, outcome-oriented, and self-motivated.
Ability to prioritize, adapt, and evolve tasks and processes in a fast-paced environment.
Effectively manage a variety of Data Management tasks for multiple clinical studies at different stages of activity.
Robust experience with EDC systems. Medidata skills strongly preferred. This includes, but is not limited to, awareness of iMedidata Cloud User and Site Administration, experience with Rave Local Lab Administration, Rave Coder, RTSM or other IRT system integrations, Rave Safety Gateway, and Rave Imaging.
Advanced awareness of data collection and data cleaning best practices.
Firm understanding and proven success managing vendors and data transfer workflows.
Practical knowledge of ICH, FDA, and GCP regulations and guidelines, and general knowledge of industry data collection and reporting standards and best practices, such as SDTM and CDISC/CDASH.
No travel required.
Physical Requirements: Must possess mobility to work in a standard office setting and use standard office equipment, including a computer; vision to read printed materials and a computer screen; and hearing and speech to communicate in person, before groups, and over the telephone. This is primarily a sedentary office classification although standing in work areas and walking between work areas may be required. Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard, mouse, or calculator, and to operate standard office equipment. Positions in this classification occasionally bend, stoop, kneel, reach, push, and pull drawers open and closed to retrieve and file information. Employees must possess the ability to lift, carry, push, and pull materials and objects weighing up to 25 pounds.
This role can be based at our Hayward or Brisbane, CA locations (preferred) or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $136,000 – $146,000. For remote-based candidates, the salary range may vary based on local market data. Factors such as relevant experience, education, duration of experience, and length of industry experience will influence the actual salary offered. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: https://arcusbio.com/careers/.
EOE
Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
At Two Six Technologies, we build, deploy, and implement innovative products that solve the world’s most complex challenges today. Through unrivaled collaboration and unwavering trust, we push the boundaries of what’s possible to empower our team and support our customers in building a safer global future.
Two Six Technologies is seeking a Systems Administrator for our Contracts and Procurement team. We are a high-growth organization with unique expertise and innovative products that support missions critical to U.S. national security.
You will assist in the implementation of our new contracts-lifecycle-management (CLM) and procure-to-pay (P2P)systems. This position offers a unique opportunity to work on critical and transformational projects.
This is mostly a remote position working from Washington Metro area with monthly travel to our local offices.
What You Will Do:
System Administration: Master Data Maintenance for records; develop and maintain Standard Operating Procedures (SOPs) and formal documentation; requirements gathering, testing, and configuration for issue resolution and enhancements.
User Training: Internal and External User Support, User Provisioning, Developing and maintaining training materials including quick reference cards, web videos, and hosting live sessions.
Compliance and Ad Hoc Reporting: Support mandatory compliance reporting including small business reporting, FFATA, GIDEP, and other data calls. Complete ad-hoc reporting for internal and external customer needs.
Entity Management and Reps and Certs: Maintain accurate and up-to-date SAM.gov registrations, Facility CAGE code management, and PIEE.
External Systems: Centralize the administration of customer or supplier systems.
Special Projects: Assist in the transition of contract, subcontract, and procurement documents for the new CLM and P2P system, including the transposition of metadata, identifying key metadata elements, tagging documents and normalizing naming conventions, diligently tracking missing information and partnering with staff to resolve, and review accuracy against original documents.
What You Will Need:
Bachelor’s degree or equivalent relevant experience and professional training
2+ years of relevant experience supporting Federal prime contracts
Familiarity with reading and locating pertinent information within federal prime contracts, including but not limited to FAR clauses, contractual requirements, and monetary values.
To be a self-starter and problem solver that can adapt to growing business needs
System Experience:
Experience with SAP Ariba or comparable P2P system
Experience with Unanet GovCon or comparable ERP system
Experience with a contract lifecycle management (CLM) system such as iCertis
Experience with EQUIP or similar government property management system
Experience with Atlassian products such as JIRA and Confluence
Experience with federal systems such as SAM.gov and FPDS
Clearance needed:
Eligibility to obtain and maintain a government security clearance
Two Six Technologies is committed to providing competitive and comprehensive compensation packages that reflect the value we place on our employees and their contributions. We believe in rewarding skills, experience, and performance. Our offerings include but are not limited to, medical, dental, and vision insurance, life and disability insurance, retirement benefits, paid leave, tuition assistance and professional development.
The projected salary range listed for this position is annualized. This is a general guideline and not a guarantee of salary. Salary is one component of our total compensation package and the specific salary offered is determined by various factors, including, but not limited to education, experience, knowledge, skills, geographic location, as well as contract specific affordability and organizational requirements.
Ready to make the first move towards growing your career? If so, check out the Two Six Technologies Candidate Journey! This will give you step-by-step directions on applying, what to expect during the application process, information about our rich benefits and perks along with our most frequently asked questions. If you are undecided and would like to learn more about us and how we are contributing to essential missions, check out our Two Six Technologies News page! We share information about the tech world around us and how we are making an impact! Still have questions, no worries! You can reach us at Contact Two Six Technologies. We are happy to connect and cover the information needed to assist you in reaching your next career milestone.
Two Six Technologies is an Equal Opportunity Employer and does not discriminate in employment opportunities or practices based on race (including traits historically associated with race, such as hair texture, hair type and protective hair styles (e.g., braids, twists, locs and twists)), color, religion, national origin, sex (including pregnancy, childbirth or related medical conditions and lactation), sexual orientation, gender identity or expression, age (40 and over), marital status, disability, genetic information, and protected veteran status or any other characteristic protected by applicable federal, state, or local law.
If you are an individual with a disability and would like to request reasonable workplace accommodation for any part of our employment process, please send an email to [email protected]. Information provided will be kept confidential and used only to the extent required to provide needed reasonable accommodations.
Additionally, please be advised that this business uses E-Verify in its hiring practices.
· Changing Lives – As a Technical Service Specialist, you provide software and hardware support for our Hospital and Clinic customers via telephone to ensure prompt resolution of customer issues for a diverse range of medical devices in the neurology area
· Global Environment – You can expect to work closely with Sales, Hardware, and Customer Service groups to communicate customer feedback and resolve issues using SalesForce
· Troubleshooting on networking issues, Microsoft Office Platform, and Windows computer systems
· Training – you may not know the ins and outs of medical device products, but quality is important to you, and you are hungry to learn our quality system and be part of this
meaningful industry
· Career Development – the longer you work with us, the more you learn and develop skills for roles in our other areas like Technical Services management, Operations, and Engineering
What we are looking for:
· Bachelor’s degree (B.A.) from four-year college or university in Computer Science, IT or related area; minimum of five years clinical Sleep experience. Equivalent combination of education and experience may be considered.
· Registered Electromyography Technologist R. T. (EMG) or equivalent experiencerequired.
· Knowledge of network protocols (UDP, TCP/IP, Ethernet, HTTP). You understand how bits and bytes get through a Network.
· Experience with Windows 7, 10, 11; Windows Server operating systems
· Experience with troubleshooting SQL Server, Citrix Server, and Microsoft Office issues
· Excellent problem solving, organizational, analytical and written/verbal communications skills are required
· Preferred: A+ Certificate or EMG background
· Preferred: Bilingual English/French is a plus
We are PASSIONATE about:
Natus Medical Incorporated is recognized by healthcare providers globally as the source for solutions to screen, diagnose and treat disorders of the brain, neural pathways. Our vision is to deliver innovative and trusted solutions to advance the standard of care and improve patient outcomes and quality of life. Natus products are used in hospitals, clinics and laboratories worldwide.
Travel Required: Less than 5%
Compensation and Benefits: Comprehensive benefit package that starts on your 1st day! Including:
Medical, Dental, Vision
401K Contribution
7 paid holidays + 2 floating holidays of your choosing
Generous paid time off plan (4 weeks to start- hours accrued)
Tuition reimbursement assistance eligibility after your first year
Annual Bonus Plan Eligibility
And more!
Natus Pay Transparency Details The pay range for this position is $60K-95K annually. The actual base pay offered may vary depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. At Natus, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.
Natus Medical Incorporated is recognized by healthcare providers globally as the source for solutions to screen, diagnose and treat disorders of the brain, neural pathways and sensory nervous system. Our vision is to deliver innovative and trusted solutions to advance the standard of care and improve patient outcomes and quality of life. Natus products are used in hospitals, clinics and laboratories worldwide.
EEO Statement: Natus Medical is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status.
The Coder Specialty Office assures the integrity of the Norton Medical Group billing, insurance, coding, and accounting and referral functions. The incumbent serves as a liaison between the practice and the billing office as well as the accounting department of Norton Healthcare. In performing job functions, utilizes age appropriate principles of growth and development for patients of all ages according to the practice specialty.
**This position offers a fully remote work opportunity. Employees in this role must reside in one of the following states to be considered for fully remote positions: Kentucky, Indiana, Missouri, Ohio, Tennessee, Alabama, Mississippi, North Carolina, or South Carolina.** Qualifications
Required:
One year medical coding in a specialty office
One of: CCA or CCS or CIC-ICD or COC or CPC or RHIA or RHIT
Desired:
Diploma
Certified Coding Associate OR Certified Coding Specialist OR Certified Inpatient Coder ICD-10 OR Certified Outpatient Coding OR Certified Professional Coder OR Registered Health Information Administrator OR Registered Health Information Technician
Discover meaningful career opportunities at NortonHealthcareCareers.com. Norton Healthcare Careers — Together, We Will.
Norton Healthcare is a leader in serving adult and pediatric patients from throughout Greater Louisville, Southern Indiana, the commonwealth of Kentucky and beyond. The not-for-profit hospital and health care system is Louisville’s third largest employer, with more than 17,000 employees.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.
Do you want to join a team of internationally known experts helping to educate Customers and providing them with helpful solutions? As a Technical Services Specialist at STERIS, you will be a subject matter expert for key pharmaceutical and biopharmaceutical Customer accounts, providing technical information and support for projects related to product technology and product application for a specialized area within the Life Sciences Contamination Control business. You will also coordinate project activities with other departments and collaborate with assigned team members on a project basis.
This is a remote based Customer facing position. To support and service our Customers in this assigned territory candidates must be based out of: anywhere in the US (Cleveland or Philadelphia are preferred).
What will you do as a Technical Service Specialist:
Provides technical information and expertise to key Customer accounts with focus on Contamination Control, Sterility Assurance and Validation of sterilization processes, with the objective of resolving complex pharmaceutical and biopharmaceutical industry Customer challenges. Support provided through telephone and written correspondence, generation of literature, lab analyses and direct field support.
Manages projects and coordinates and oversees technical and/or lab activities within area of specialization. Serves as liaison with R&D groups for scientific and technical support. Reports on product field trial activity.
Maintains subject matter expertise by reading current published literature, attending and presenting at scientific meetings and seminars, and collaborating with technical experts.
Increases sales force effectiveness by administering global pharmaceutical and biopharmaceutical industry Customer and professional education programs. Works with global Customers and sales representatives on product applications, appropriate product usage, and providing background information and analytical support.
Contributes ideas and information for new products, processes and applications relative to the business unit.
The Experience, Skills, and Abilities Needed:
Required
Bachelor’s degree in Microbiology, Science or Biomedical Engineering
Minimum five (5) five years related work experience
Current knowledge of sterilization and contamination control within pharmaceutical and biopharmaceutical industry, including regulatory requirements in area of specialization
Ability to travel up to 40-50% annually, domestic and international
Preferred
Master’s degree preferred
Knowledge and experience in sterilization processes and validation, environmental contamination control, cleanroom operations, and/or aseptic pharmaceutical product manufacturing are desirable
Strong project management skills including excellent verbal & written communication skills as well as presentation skills in both small and large group settings
What STERIS Offers:
We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being, and financial future.
Here is just a brief overview of what we offer:
Base Salary + Incentive Compensation Program
Flexible Time Off + 9 Corporate Holidays Per Year
Excellent Healthcare, Dental, and Vision Benefits
Healthcare and Dependent Flexible Spending Accounts
Long/Short Term Disability Coverage
401(k) with a Company Match
Parental Leave
Tuition Reimbursement Program
Additional Add-On Benefits/Discounts
Opportunities for Advancement in a Stable Long-Term Career
Pay range for this opportunity is $78,500.00 – $109,987.50. This position is eligible for bonus participation.
Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc.
Employees (and their families) may enroll in our company-sponsored medical, dental, vision, flexible spending, health savings account, voluntary benefits, supplemental life/AD&D plans and the company’s 401k plan. Employees are covered by an employee assistance program (also available to household members) and long-term disability. Full-Time Employees are also eligible for short-term disability. Full-time Employees will also receive Paid Time Off (PTO) based on years of service and paid Holidays. Part-time employees working 20 or more hours receive a pro-ration of the full-time PTO allocation and paid Holidays based on their standard hourly work week. Full-Time employees are eligible for four weeks of paid parental leave. Part-time employees also receive paid parental leave, pro-rated based on their standard hourly work week.
STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare, life sciences and dental products and services. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 17,000 associates and Customers in more than 100 countries.
If you need assistance completing the application process, please call 1 (440) 392.7047. This contact information is for accommodation inquiries only and cannot be used to check application status.
STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.
The full affirmative action program, absent the data metrics required by § 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location’s HR Office during normal business hours.
Provides high level technical competency and subject matter expertise analyzing physician/provider documentation contained in Complex Outpatient (CO)/Ambulatory Surgery health records to determine the principal diagnosis, secondary diagnoses, principal procedure and secondary procedures. Assigns appropriate Ambulatory Procedure Classification (APC) codes, required modifiers, NCCI and LCD/NCD edits.
Utilizes encoder software applications, which includes all applicable online tools and references, in the assignment of International Classification of Diseases, Clinical Modification (ICD-CM) diagnosis and procedure codes and Current Procedural Terminology (CPT) / Healthcare Common Procedure Coding System (HCPCS) procedure codes. Uses encoder software and coding abstracting system edit features to resolve edits prior to completing coding. Interprets, researches and resolves claim edits that occur after coding to support timely final claims submission.
Assigns appropriate code(s) by utilizing coding guidelines established by:
The Centers for Medicare/Medicaid Services (CMS) ICD-CM Official Coding Guidelines for Coding and Reporting, ICD-PCS Official Guidelines for Coding and Reporting
American Hospital Association (AHA) Coding Clinic for International Classification of Diseases, Clinical Modification
The American Medical Association (AMA) for CPT codes and CPT Assistant
American Health Information Management Association (AHIMA) Standards of Ethical
Coding
Revenue Excellence/Health Ministry (HM) coding procedures and guidelines
ESSENTIAL FUNCTIONS
Knows, understands, incorporates, and demonstrates the Trinity Health Mission, Vision, and Values in behaviors, practices, and decisions.
Navigates the patient health record and other computer systems/sources to accurately determine diagnosis and procedures codes, APCs, CPT, HCPCS codes, modifiers, internal edits and claim edits that could impact hospital reimbursement.
Interprets bundling and unbundling guidelines (NCCI edits) as well as LCDs/NCDs edits and payer policies.
Works Outpatient internal and external claim edits and routes non-coding ones to appropriate owners e.g., Revenue Integrity, Billing, etc.
Adheres to Inpatient coding quality and productivity standards established by Revenue Excellence/HM.
Demonstrates knowledge of current, compliant coder query practices when consulting with physicians, Clinical Documentation Specialists (CDS) or other healthcare providers when additional information is needed for coding and/or to clarify conflicting or ambiguous documentation.
Utilizes EMR communication tools to track missing documentation or Outpatient queries that require follow-up to facilitate coding in a timely fashion.
Works with HIM and Patient Business Services (PBS) teams, when needed, to help resolve billing, claims, denial and appeals issues affecting reimbursement.
Maintains CEUs as appropriate for coding credentials as required by credentialing associations.
Maintains current knowledge of changes in Outpatient coding and reimbursement guidelines and regulations e.g., new modifiers, wound care.
Identifies, and attempts to resolve, coding and/or EMR workflow issues that can impact coding.
Exhibits awareness of health record documentation or other coding ethics concerns. Notifies appropriate leadership for assistance, resolution when appropriate.
Performs other duties as assigned by Leadership.
Maintains a working knowledge of applicable coding and reimbursement Federal, State and local laws and regulations, the Compliance Accountability Program, Code of Ethics, as well as other policies and procedures in order to ensure adherence in a manner that reflects honest ethical and professional behavior.
MINIMUM QUALIFICATIONS
Completion of an AHIMA or AAPC approved coding program or Associate’s degree in Health Information Management or a related field or an equivalent combination of years of education and experience is required. Bachelor’s degree in Health Information Management (HIM) or related healthcare field is preferred.
Registered Health Information Technician (RHIT) or Registered Health Information Administrator (RHIA) or Certified Coding Specialist (CCS) is required.
Three (3) years of current acute care or Complex Outpatient experience is required.
Extensive, comprehensive working knowledge of medical terminology, Anatomy and Physiology, diagnostic and procedural coding and APC assignment. Must be proficient on identifying NCCI, LCD/NCD edits to ensure accurate hospital reimbursement.
Current experience utilizing encoding/grouping software and Computer Assisted Coding (CAC) is preferred.
Ability to use a standard desktop/laptop, email and other Windows applications, if needed, Internet and web-based training tools preferred.
Strong oral and written communication skills. Ability to communicate effectively with individuals and groups representing diverse perspectives.
Ability to research, analyze and assimilate information from various sources based on technical and experience-based knowledge. Must exhibit critical thinking skills, strong problem- solving skills and the ability to prioritize workload.
Excellent organizational and customer service skills. Ability to perform frequent detailed tasks and provide productivity standard driven results. Ability to adapt to change and be flexible with work priorities and interruptions.
Must be comfortable functioning in a 100% virtual, collaborative, shared leadership environment. with minimal supervision and able to exercise independent judgement.
Must possess a personal presence that is characterized by a sense of honesty, integrity, and caring with the ability to inspire and motivate others to promote the philosophy, mission, vision, goals, and values of Trinity Health.
PHYSICAL AND MENTAL REQUIREMENTS AND WORKING CONDITIONS
Must be able to set and organize own work priorities and adapt to them as they change frequently. Must be able to work concurrently on a variety of tasks/projects in physical or virtual environments that may be stressful with individuals having diverse personalities and work styles.
Must possess the ability to comply with Trinity Health policies and procedures.
Must be able to spend majority of work time utilizing a computer, monitor, and keyboard.
Must be able to work with interruptions and perform detailed tasks.
If applicable, involves a wide array of physical activities, primarily standing, sitting and reading. Must be able to sit for long periods of time.
Must be able to travel to various Trinity Health sites as necessary.
If applicable, telecommuting (working remotely), must be able to comply with Trinity Health’s and the Region/HM Working Remote Policy.
Hourly Pay Range: $27.42 – $41.13
The above statements are intended to describe the general nature and level of work being performed by persons assigned to this classification. They are not to be construed as an exhaustive list of duties so assigned.
Our Commitment to Diversity and Inclusion
Trinity Health is one of the largest not-for-profit, Catholic healthcare systems in the nation. Built on the foundation of our Mission and Core Values, we integrate diversity, equity, and inclusion in all that we do. Our colleagues have different lived experiences, customs, abilities, and talents. Together, we become our best selves. A diverse and inclusive workforce provides the most accessible and equitable care for those we serve. Trinity Health is 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 law.
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