Manager, Clinical Data Review - Medical Devices (on-site)
$114k - $228kAbbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
- Career development with an international company where you can grow the career you dream of.
- Employees can qualify for 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, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.
The Opportunity
We are looking for our next Manager, Clinical Data Review to lead our team on-site out of our Sylmar, CA location. As a manager, the individual has primary management responsibility directly or through subordinates for all data related to clinical studies. This new team member will have accountability for all data entry activities, Case Report Form (CRF) design, edit check specifications, and other requirements of the Clinical databases, providing datasets and performing data cleaning for analysis. Additionally, will identify and routinely use the most effective, cost efficient and best business practice to execute processes; continually evaluate their effectiveness and appropriateness. The Manager, Clinical Data Review will exercise judgment in planning, organizing and performing work; monitor performance and report statuses to executive management as well as assures that quality of services meets internal and external customer requirements. The individual will remain current on developments in field(s) of expertise to ensure that clinical trial protocol elements are appropriately captured on CRFs and databases for analysis; responsible for ensuring database integrity.
What You’ll Work On
- Responsible for hiring and retaining a diverse, highly qualified data management staff and for providing career coaching, growth, and personal development. Accountable for staff development: critiques, instructs, mentors, evaluates, and coaches. Ensures staff is appropriately trained in processes and procedures; ensures established processes and procedures are being followed and documented. Accountable for the performance of subordinates and work output of managed subcontractors. Maintains a safe work environment and a strong customer focus. Models optimum leadership competencies to inspire an energized, empowered and accountable work force, ethical behavior, favorable community image, and actualization of the SJM Guiding Principles and values.
- Manages data entry, data cleaning, data deliverables, and other data management activities.
- Oversees the development of CRFs, edit check specifications, and additional data collection requirements required for tracking and analysis.
- Manages processes to ensure data integrity via appropriate data management processes (e.g., protocol compliance reporting, querying for missing or discrepant data, evaluating data outliers, performing data quality checks, etc.).
- Manages custom requests and reporting from clinical databases (i.e., Oracle Clinical, etc.) made by the Clinical department and other departments.
- Provides other departments with outputs from clinical databases as necessary (e.g., Development, Marketing, etc.).
- Remains current on developments in field(s) of expertise, regulatory requirements, and industry trends and trains staff regarding changing regulations that affect clinical studies. Maintains knowledge of current and pending regulations through literature, trade journals, professional associations, and by attending conferences.
- Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and manages the execution of goals through coaching and mentoring. Maintains a safe and professional work environment.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Required Qualifications
- Bachelor's degree in a science-related field or an equivalent combination of education and experience
- Minimum 8 years’ progressively more responsible experience in the pharmaceutical, bio-technology or medical device industry; must be able to apply the fundamental concepts and practices to conduct needs assessment, research and develop information for market development purposes.
- Advanced computer skills in graphics, word-processing, databases, authoring programs, etc.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
- Ability to work effectively within a team in a fast-paced changing environment.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Multi-tasks, prioritizes and meets deadlines in timely manner.
- Strong organizational, planning, and follow-up skills and ability to hold others accountable.
Preferred Qualifications
- Experience working in a broader enterprise/cross division business unit model
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at , on Facebook at and on Twitter @AbbottNews. Connect with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is $114,000.00 – $228,000.00. In specific locations, the pay range may vary from the range posted.]]><
$114k - $228k
...StatesEmployment type: full timeCategory: Medical and Clinical AffairsIndustry:... ...products in diagnostics, medical devices, nutritionals and branded... ...We are looking for our next Manager, Clinical Data Review to lead our team on-site out of our Sylmar, CA location...WebsiteMedical deviceFor contractorsFor subcontractor- ...Abbott seeks a Manager of Clinical Data Review to lead a team overseeing clinical study data management... ...integrity, and regulatory compliance for medical devices. The role manages staff, CRF design,... ...-departmental reporting from on-site locations in California or Minnesota...WebsiteMedical device
- ...Abbott seeks a Manager, Clinical Data Review to lead a data management team at the Maple Grove, Minnesota site. The role oversees clinical trial data integrity, Case Report Form design, database management, and staff development while ensuring regulatory compliance....Website
- ...Title: Clinical Data Manager Location: Maple Grove, MN Duration... ...management plan, and site and central monitoring... ...customer-face of Data Review and its primary... ...pathophysiology, therapy and device. Consultants... ...Waiting Period: ~ Medical and Prescription Drug...WebsiteMedical deviceTemporary workWork experience placementFlexible hours
- ...ARE We are a growing medical device company developing... ...replacement through pivotal clinical development, with a... ...seeking a Clinical Data Manager to support the execution... ..., documentation review, and resolution of outstanding... ..., clinical research sites, and external vendors...WebsiteMedical deviceFull time
$61.3k - $122.7k
...businesses and products in diagnostics, medical devices, nutritionals and branded... ...Grove MN currently has an on-site opportunity for an Associate Clinical Data Manager . The Associate Clinical Data... ...ll Work On Works with Data Review Manager in the study start-up...WebsiteMedical deviceWork experience placementShift work- Abbott is seeking a Manager, Clinical Data Review in Maple Grove, MN to lead a data management team and ensure high-quality clinical study data. The role includes CRF design, edit checks, and data cleaning for analysis, while implementing risk-based quality management and...For contractors
$150k - $175k
...people's lives. Our medical devices, software and... ...and execution of clinical trials in collaboration... ...combines people management with hands-on contribution... ..., including site and principal... ...of Institutional Review Board (IRB) approvals... ...CTMS), Electronic Data Capture (EDC) systems...WebsiteMedical deviceMinimum wageOngoing contractFull timeContract workTemporary workWork at officeLocal areaRemote workWorldwideNight shift3 days per week$68k - $80k
...We are a growing medical device company developing... ...replacement through pivotal clinical development, with a... ...execution-from site documentation and clinical data to payments, device... ..., and comfortable managing multiple priorities... ...conduct internal review of trial documents...WebsiteMedical deviceFull timeWork at officeLocal areaRemote workFlexible hoursShift work$38 - $43 per hour
...- $43.00/hr Hiring: Pharmaceutical/Medical Device | Resumes to ****@*****.***... ...Pharmaceutical / Medical Devices Position Title: Clinical Data Manager Duration: 6 months Contract (... ...requirements. Lead clinical data review, cleaning, and quality oversight...Medical deviceHourly payContract workTemporary work$135k - $175k
ABOUT INSPIRE MEDICAL SYSTEMSInspire is... ...kind medical device designed to make... ...for overseeing clinical activities related... ...and performing/managing the daily in-... ...clinical site selection and activation... ...bodies, reviewing adverse event trends... ...Committees and Data Safety...WebsiteMedical deviceWork experience placementInterim roleLocal areaFlexible hours- ...promotion , our small, growing medical device client is adding a Clinical Trial Coordinator to provide... ...trial execution: from site documentation and clinical data to payments, device logistics,... ...oriented, proactive, and comfortable managing multiple priorities while ensuring...WebsiteMedical deviceWork at officeShift work
$171k - $273k
...TitleDirector of Clinical OperationsJob... ...regulatory bodies, sites, and vendors... ...IT, Clinical/Medical, Regulatory, Legal... ...stakeholders, manage vendors and... ...enrollment, monitoring, data collection,... ..., enrollment reviews, budget reviews... ...within the medical device industry,...WebsiteMedical deviceFull timeContract workWork at officeLocal areaImmediate startWork visaRelocation package3 days per week$108k - $150k
...Job Duties Medical Affairs Program Manager Location: Minneapolis... ...a member of the Clinical Science & Office... ...deliver medical device technical... ...publications of data to ensure relevant... ...assigned Process and review clinical study... ...Place of Work On-site Requisition ID...WebsiteMedical deviceHourly payFull timeWork at officeImmediate startFlexible hoursShift work$175k - $200k
...people's lives. Our medical devices, software and... ...establishing and leading the Clinical Operations function while directly managing a team of Clinical... ..., including site and principal... ...activation, Institutional Review Board (IRB)... ...CTMS), Electronic Data Capture (EDC) systems...WebsiteMedical deviceMinimum wageOngoing contractContract workTemporary workFor contractorsWork at officeLocal areaRemote workWorldwideNight shift3 days per week- ...provides HR leadership for both site-based (Minnesota & Utah) and remote... ...effectiveness, and change management. Coordinate global talent review, succession planning, leadership... ...~ Experience in manufacturing, medical device, life sciences, regulated, multi-...WebsiteMedical deviceRemote work
$68.8k - $123.8k
...vast network of over 100 sites worldwide, Jabil... ...role involves supporting medical device manufacturing operations... ...analysis of data to identify trends, opportunities... ...Participate in design reviews and provide quality... ...performance reports to management.How will you get here?...WebsiteMedical deviceFull timeWork at officeLocal areaWorldwide- ...Quality Engineering Manager Develops, establishes and maintains... ...support departmental, functional, site, divisional and corporate... ...and work independently Medical device experience Coordination and... ...surveillance report, periodic document reviews Experience post market...WebsiteMedical deviceContract work
$100.9k - $151.3k
...Overview About Cretex Medical: Cretex Medical... ...the medical device industry. Our... ...Control Manager Position Summary... ...KPIs aligned with site quality, safety... ...controls. Apply data‑driven tools such... ...‑functional reviews and audits. Qualifications... ...onsite health clinics, discretionary...WebsiteMedical deviceHourly payContract workTemporary workLocal areaShift work- ...improvement of the Quality Management System (QMS), ensuring... ...MN at the Arbor Lakes Site Location with the... ...audits and management review. Ensure compliance... ...systemic risks and drive data-based improvements.... ...years of experience in a medical device manufacturing, quality...WebsiteMedical deviceWork at office3 days per week
- ...releases supporting complex medical device systems. You will own maintenance... ...employees to work on-site at our Maple Grove location.... ...functional subject matter experts for review and approval as required.Lead... ...disposition.Proactively manage integrated project and technical...WebsiteMedical deviceHourly payRelocationShift work
$22.84 - $41.11 per hour
...network of over 100 sites worldwide, Jabil... ...day-to-day basis, managing workflow, making daily... .../rejected devices not on approved list... ...Writing performance reviews (with Supervisor approval... ...experience in the medical device industry is... ..., external market data, and consideration...WebsiteMedical deviceHourly payFull timeWork at officeLocal areaWorldwideFlexible hoursShift workWeekend work- ...improvement of the Quality Management System (QMS), ensuring... ...MN at the Arbor Lakes Site Location with the... ...audits and management review.Ensure compliance with... ...systemic risks and drive data-based improvements.... ...years of experience in a medical device manufacturing, quality...WebsiteMedical deviceHourly payWork at officeShift work3 days per week
$68.8k - $123.8k
...vast network of over 100 sites worldwide, Jabil... ...role involves supporting medical device manufacturing operations... ...analysis of data to identify trends, opportunities... ...Participate in design reviews and provide quality... ...performance reports to management. How will you get here...WebsiteMedical deviceWork at officeLocal areaWorldwide- ...Clinical Trial Payments/Clinical Trial Coordinator Our dynamic... ...clinical-stage, fast-paced medical device startup is developing novel... ...specialist will be crucial in managing clinical trial payments and... ...and ensure consistency across sites. Requires a strong...WebsiteMedical device
- ...Clinical Risk Evaluation (CRE) Senior Scientist/Program Manager Abbott is a global healthcare leader that... ...in diagnostics, medical devices, nutritionals and branded... ...sources of relevant data, interprets, evaluates... ...and Physician Reviewers). Review, edit, and...Medical deviceWork experience placement
$100k - $115k
...from automotive, aerospace, and medical device sectors. Key Responsibilities Supplier Quality Management Develop and maintain... ...initiatives at supplier sites, including Lean and Six Sigma... ...utilizing PPAP principles. Review and approve supplier control...WebsiteMedical deviceWeekly pay$70k - $86k
...invasive, interventional medical technologies. We... ...of-a-kind medical devices for the... ...delivery, cardiac rhythm management, structural heart,... ...as the primary on-site HR partner for a... ...management, talent reviews, development planning... ...records and HRIS data in accordance with...WebsiteMedical deviceWork at office- ...align on the category strategy, manage product costs, achieve... ...facilitating supplier business reviews to evaluate all aspects of quality... ...projects; support site purchasing team(s) as neededRequired... ..., etc.)Experience working in medical devices or similarly regulated industry...WebsiteMedical deviceHourly payContract workWork at officeLocal areaShift work3 days per week
$52k - $67k
...formulation development, clinical and commercial... ...From our world-class sites in North America and Asia... ...packaging operations. Reviews executed manufacturing... ...projects assigned by QA Management. MINIMUM EDUCATION... ...preferably Pharmaceutical or Medical Device) with demonstrated...WebsiteMedical deviceContract workLocal areaWorldwideFlexible hours
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