- Review and provide feedback on study Clinical Investigation Plan (CIP)/Clinical Performance Study Protocol (CPSP) to ensure the data collection requirements are clear.
- Provides clinical data management leadership within the study team to align on and drive data collection requirements for one or more studies.
- Efficiently plans, coordinates, and delivers complete, high quality and reliable, clinical trial data in a timely manner for assigned projects.
- Responsible for end-to-end clinical data management activities and serves as a primary point of contact for team members.
- Provides strong quality and project oversight over third party vendors responsible for data management deliverables.
- Enforces data standard conventions and quality expectations for clinical data per defined processes.
- Authors, reviews/revises data management related study documents and plans including Data Management Plan (DMP), Data Management Report (DMR), electronic Case Report Forms (eCRFs), Database Configuration Specifications (DCS), External Data Specifications (EDS), eCRF Completion Guidelines, and other study documents to ensure quality and standardization.
- Coordinates, participates and completedatabase User Acceptance Testing (UAT) and related tasks.
- Represents Data Management on cross-functional project teams.
- Review and validate clinical study data to ensure consistency, accuracy, integrity, and completeness.
- Provide project metric reports, status updates, study progress, feedback, and advice to project teams on site performance issues, and data trending.
- Manage the database implementation, lock and close-out processes and procedures in accordance with established processes.
- Maintain study documentation on an ongoing basis and ensure that all documentation and filing is inspection ready.
- Contribute to process improvements, staff learning and development.
- Provides mentorship and training to junior Data Management staff.
- Oversight for outsourced studies.
- Ability to travel up to 10%.
- Bachelors degree or relevant industry experience required. 5 years direct data management experience.
- Demonstrated leadership quality and advanced organizational and interpersonal skills.
- Detail oriented with excellent written and verbal communication skills and experience working in cross-functional setting.
- Advanced knowledge of device development process, FDA/ISO guidelines and industry standard practices regarding data management.
- Experience with clinical data lifecycle from database set-up and maintenance to database lock and archiving.
- Competent in Excel and/or SAS programming.
- Strong knowledge and experience of EDC systems (Veeva preferred); demonstrated knowledge of Microsoft Office skills and well versed in industry trends and emerging technologies supporting data collection.
- Multidisciplinary knowledge across functional areas in clinical research.
- Ability to work collaboratively on multi-disciplinary project teams and develop productive relationships.
- Strong project management skills.
- Ability to work independently with minimal supervision, should be able to perform most required tasks with minimal guidance.
- Experience working with CROs/vendors.
-
Nexus Dynamics Lake City, United StatesTogether, keeping finances and people in mind. The WM Group is a leading information service provider for the financial industry. With over 450 employees, we have been supplying professional players in the financial sector with news and data solutions for over 75 years. As the le ...
-
Data Manager
2 weeks ago
University of Utah Salt Lake City, United StatesDetails · Open Date 02/07/2024 · Requisition Number PRN37657B · Job Title Clinical Data Manager III · Working Title Data Manager · Job Grade G · FLSA Code Administrative · Patient Sensitive Job Code? No · Standard Hours per Week 40 · Full Time or Part Time? Full Time · Shift Day ...
-
Data Manager
1 week ago
University of Utah Salt Lake City, United StatesDetails · Open Date 02/07/2024 · Requisition Number PRN37657B · Job Title Clinical Data Manager III · Working Title Data Manager · Job Grade G · FLSA Code Administrative · Patient Sensitive Job Code? No · Standard Hours per Week 40 · Full Time or Part Time? Full Time · ...
-
Data Entry and Data Management
1 week ago
MILLENNIUMSOFT Salt Lake City, United StatesPosition : Data Entry and Data Management · Location : Salt Lake City, UT · Duration : 3+ Months Contract · Total Hours/week : 40.00 · 1st Shift · Position Purpose: · Data entry and data management. Creating or modifying software record files. · Attention to detail. Must have c ...
-
Data Management
3 weeks ago
Cambia Health Solutions Salt Lake City, United States Full timeData Governance Internship · Idaho, Oregon, Utah or Washington - Remote/Hybrid · This full-time, 12-week internship is scheduled to begin in June 2024 · Join our Data Governance team which facilitates cross-functional collaboration to maintain high quality data across the e ...
-
Data Management Associate
3 weeks ago
University of Utah Salt Lake City, United StatesThe Campus Store is seeking a detail-oriented and motivated Part-Time Data Management Associate to join our team. The ideal candidate will be responsible for assisting in various aspects of data management, including data entry, data cleaning, database maintenance, and quality as ...
-
Data Delivery Manager
1 week ago
ZoomInfo Salt Lake City, United States**Data Delivery Manager** · **Salt Lake City, Utah, United States** · Apply Now · At · **ZoomInfo** we encourage creativity, value innovation, demand teamwork, expect accountability and cherish results. If you are collaborative, take initiative, and get stuff done we want to ta ...
-
IT project manager data center
4 days ago
Infinity Enterprises Bountiful, United StatesThe Schwarz IT KG is responsible as the central IT service provider for the selection, provision, operation and further development of IT infrastructures, IT platforms and business applications. This includes providing IT services for Kaufland and Lidl as well as for Schwarz Dien ...
-
Manager, Clinical Data Management
1 day ago
BioFire Diagnostics Salt Lake City, United StatesPosition Summary: · Responsible for conceptualizing, organizing, and overseeing data management activities for the Clinical Affairs department. Manage Clinical Data Specialists to ensure all aspects of study data collection, management, and analysis meet the requirements to supp ...
-
Manager, Clinical Data Management
2 days ago
BioFire Diagnostics Salt Lake City, United StatesPosition Summary: Responsible for conceptualizing, organizing, and overseeing data management activities for the Clinical Affairs department. Manage Clinical Data Specialists to ensure all aspects of study data collection, management, and analysis meet the requirements to support ...
-
Manager, Data Engineering
3 weeks ago
1-800 CONTACTS Salt Lake City, United States Full timeWho we are · SeekWell is the parent company of 1-800 Contacts, Luna, and Hello Eyes. Our goal is to make it simpler, easier, and more accessible for people to get the vision care they need. We maintain the legendary, award-winning culture 1-800 Contacts started almost 30 years ag ...
-
Data Center Project Manager
2 weeks ago
Okland Construction Salt Lake City, United StatesDATA CENTER PROJECT MANAGER · POSITION SUMMARY · Okland is looking for a Project Manager to lead overall administration and technical direction of commercial construction projects and/or multiple projects totaling over $45 Million in Revenue. This position will collaborate clos ...
-
Data Center Project Manager
1 week ago
Okland Construction Company, Inc. Salt Lake City, United StatesBrief Description · DATA CENTER PROJECT MANAGER · Position Summary · Okland is looking for a Project Manager to lead overall administration and technical direction of commercial construction projects and/or multiple projects totaling over $45 Million in Revenue. This position ...
-
Sr Manager, Data Analytics
1 week ago
BioFire Diagnostics, LLC Salt Lake City, United StatesWant to see more? Find all job opportunities for both BioFire and bioMérieux worldwide by . · Description · Position Summary: · We are looking for a Data & Analytics Manager to lead our North American team and drive the delivery of data solutions for our clients and stakeholde ...
-
Clinical Data Manager II
1 week ago
University of Utah Salt Lake City, United StatesDetails · Open Date · 04/12/2024 · Requisition Number · PRN38241B · Job Title · PS Clinical Data Manager II · Working Title · Clinical Data Manager II · Job Grade · E · FLSA Code · Administrative · Patient Sensitive Job Code? · Yes · Standard Hours per Week · 40 ...
-
Sr Manager, Data Analytics
2 weeks ago
bioMerieux SA Career Site - MULTI-LINGUAL Salt Lake City, United StatesDescription · Position Summary: · We are looking for a Data & Analytics Manager to lead our North American team and drive the delivery of data solutions for our clients and stakeholders. As a Data & Analytics Manager, you will be responsible for overseeing the data strategy, gov ...
-
Sr. Manager of Enterprise Data Governance
6 days ago
CHG Medical Staffing Salt Lake City, United StatesHealthcare's helping hand. · CHG shook things up in 1979 by inventing the locum tenens staffing model. We connect doctors with patients who need their care. As the largest physician staffing firm in America, our providers treat millions of patients each year. · Our industry is ...
-
HSSE Manager, Data and Digital Tools
1 week ago
Stantec Salt Lake City, United StatesHSSE Manager, Data and Digital Tools XE ) · Description · Grow with the best. Join a smart, creative, and inspired team that accomplishes operational excellence. Bringing together individuals with diverse backgrounds, talents, and expertise, our 28,000 team members in over 400 lo ...
-
HSSE Manager, Data and Digital Tools
1 week ago
Stantec Salt Lake City, United StatesHSSE Manager, Data and Digital Tools XE ) · Description · Grow with the best. Join a smart, creative, and inspired team that accomplishes operational excellence. Bringing together individuals with diverse backgrounds, talents, and expertise, our 28,000 team members in over 400 lo ...
-
HSSE Manager, Data and Digital Tools
1 week ago
Stantec Salt Lake City, United StatesHSSE Manager, Data and Digital Tools XE ) · Description · Grow with the best. Join a smart, creative, and inspired team that accomplishes operational excellence. Bringing together individuals with diverse backgrounds, talents, and expertise, our 28,000 team members in over 400 lo ...
Principal Clinical Data Manager - Salt Lake City, United States - BD (Becton, Dickinson and Company)
Description
Job Description Summary
The Principal Clinical Data Manager is responsible for performing end-to-end Data Management activities for assigned studies.
The Principal Clinical Data Manager ensures that clinical study data is collected, processed, and validated in a consistent and appropriate manner that is consistent with BDs QMS procedures, resulting in high quality data ready for statistical analysis within the project timelines.
This position also serves to contribute to process improvement, staff learning and development.Job Description
We are
the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and its no small feat.
It takes the imagination and passion of all of usfrom design and engineering to the manufacturing and marketing of our billions of MedTech products per yearto look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which youll be supported to learn, grow and become your best self. Become amaker of possible
with us.
Responsibilities
Qualifications:
For certain roles at BD, employment is contingent upon the Companys receipt of sufficient proof that you are fully vaccinated against COVID-19.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work.
Its also a place where we help each other be great, we do whats right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do.
To learn more about BD visit?
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer.
We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
PDN
Primary Work Location
USA NJ - Franklin Lakes
Additional Locations
USA AZ - Tempe Headquarters, USA FL - Stuart Airport Road, USA GA - Covington BMD, USA IL - Vernon Hills, USA MD - Sparks - 7 Loveton Circle, USA NC - Four Oaks, USA RI - Warwick, USA TX - San Antonio
Work Shift
NA (United States of America)
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer.
We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
#J-18808-Ljbffr