Clinical Data Manager

Katalyst Healthcares and Life Sciences

Charlotte, NC

Responsibilities:

Leads all DM lifecycle activities, from study start-up, maintenance, database lock and close-out.
Independently develop DM documents including but not limited to Data Management Plans (DMP), Case Report Forms (CRFs), CRF Completion Guidelines, Edit Checks, UAT specifications, centralized monitoring plans, data flow and integrity plans, blinding plans, and data review plans. Utilize templates and standard guidelines to initiate documents, but demonstrate critical thinking, alignment-building and discretion to tailor documents to study needs.
Independently lead data cleaning activities such as, but not limited to, study team data reviews, Non-system Edit Check Output review, SAE reconciliation, and non-CRF data reconciliation. Gather cross-functional input to drive creation of custom data review plans. Evaluate options and exercise discretion to choose efficient and effective issues resolution paths.
Manage data deliverables processes and database locks, with high quality and efficiency.
Foster collaboration and relationship-building with all study team representatives (e.g. Biostatisticians, Statistical Programmers, Medical Monitors, Clinical Scientists, Clinical Project Managers, Clinical Trial Managers, CRAs, Clinical Pharmacologists, Biomarker/Bioinformatics Scientists, Medical Writers, Regulatory representatives, etc.)
DM Project Management: With oversight, ensure data management deliverables are met on time. Utilize communication, available metrics reports, experience, knowledge, and other resources to efficiently lead and coordinate all data management activities. Ensure study team members from different functional areas understand and deliver components affecting data to ensure successful execution of deliverables. Provide solutions for data management issues that arise during study conduct.
Manage/coordinate work performed by vendors/CROs as appropriate to ensure quality of product. Assist in the selection of vendors/CROs (e.g. review RFPs, attend site audits)
Performs Medical Coding as needed, works with CROs, Medical Monitors, and Clinical Scientists to coordinate activities for the medical review of clinical trial data.
Run SAS and/or R programs, review SAS and/or R logs, troubleshoot errors, and generate output. Program SAS and/or R Non-System Edit Checks/Back-end checks and SAS and/or R Data Listings as appropriate for skill level.
Evaluate CDM processes and applications for improvements; participate in working groups to develop and implement new processes and applications.
Participate in development of DM specific SOPs.
Responsible for oversight of CRO data management activities and integrating the various functional group input.
ll other duties as assigned.

Requirements:

BA or BS and a minimum of 4 years of relevant experience.
Technologically savvy; quickly picks-up new information, standards, regulations, tools, methods or software as it relates to position and profession.
Experience working within a Clinical EDC system (e.g., Medidata Rave, Veeva EDC).
Experience with managing Lab Data, such as PK, PD, and Biomarkers.
Detail-oriented; performs quality and accurate work.
Knowledgeable in GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and GCDMP.
Strong knowledge of clinical research, drug development process, and medical terminology, oncology experience preferred.
Knowledge and understanding of DM Lifecycle associated with P1-P3 studies, including pivotal, blinded, and randomized trials.
Knowledge of MedDRA and WHO Drug coding.
Project Management skills, ability to manage multiple projects and meet deadlines.
Strong interpersonal, organizational, and communication skills.
Prior experience writing specification documents and/or work instructions.
Previous vendor/CRO management.
Previous experience with RTSM, eCOA/ePRO systems.
SAS programming experience.

Apply

Vacancy posted 1 day ago

Similar jobs that could be interesting for youBased on the Clinical Data Manager in Charlotte, NC vacancy

Clinical Data Manager
...Independently develop DM documents including but not limited to Data Management Plans (DMP), Case Report Forms (CRFs), CRF Completion... ...Biostatisticians, Statistical Programmers, Medical Monitors, Clinical Scientists, Clinical Project Managers, Clinical Trial Managers...
Suggested
Katalyst Healthcares & Life Sciences
Charlotte, NC
16 hours ago
Government Healthcare Data Manager
...Consulting (GHSC) team at Marsh. The Government Healthcare Data will serve as a data team leader, working directly with actuarial... ...Act as a project lead and partner with the client to define and manage the scope of the project, serve as an expert on data...
Suggested
Work at office
Local area
Remote work
Flexible hours
3 days per week
1 day per week
Mercer Consulting
Charlotte, NC
8 hours ago
Data Governance- Manager
$99k - $232k
...Data Governance Manager At PwC, our people in data and analytics focus on leveraging data to drive insights and make informed business decisions. They utilise advanced analytics techniques to help clients optimise their operations and achieve their strategic goals....
Suggested
PwC (US)
Charlotte, NC
16 hours ago
Data Program Manager
$112k - $209k
...our search for talented visionaries and your search for important and impactful work lead to the same place.We are seeking a Data Program Manager to join K&L Gates. The Data Program Manager oversees roadmap, budget, and timelines for enterprise data initiatives as a...
Suggested
Full time
Temporary work
Work at office
Local area
Remote work
K&L Gates
Charlotte, NC
2 days ago
Product Data & Agentic Commerce Manager
$94.4k - $293.8k
...value for our clients by combining creativity, technology, and data-driven intelligence. Within Song, the Customer Technology - Commerce... ...leading brands.Work at the intersection of product experience management, AI discoverability, and digital commerce — where data quality...
Suggested
Full time
Live in
Work at office
Local area
Accenture
Charlotte, NC
3 days ago
Senior Manager Data Lead
$193.73k - $322.88k
...and operate integrated/verticalized sector solutions in software, data, AI, network, and hybrid cloud infrastructure. These solutions... ...insights, and services. We help clients innovate, enhance, and manage their data, AI, and analytics capabilities, ensuring they can grow...
Local area
Visa sponsorship
Deloitte
Charlotte, NC
8 hours ago
Life Sciences Planning Transformation Data & AI Senior Manager
...and Engineering, and Talent, with advanced capabilities in AI and Data, Industry and Process, and Technology. We serve approximately 9,... ...of advanced technologies.The Work:Accenture is seeking a Senior Manager to lead Planning transformation work within our Supply Chain &...
Full time
Live in
Work at office
Local area
Shift work
Accenture
Charlotte, NC
4 days ago
Oracle Utilities Meter Data Management (MDM) Functional Lead
...more about Accenture's Oracle practice (.)You Are:Accenture is seeking an experienced Oracle Customer Cloud Service (CCS) Meter Data Management System (MDMS) Functional Lead to join our enterprise technology team. This role is pivotal in managing and optimizing Clients...
Full time
Work experience placement
Live in
Work at office
Local area
Remote work
Accenture
Charlotte, NC
16 hours ago
SAP Data Migration Manager/Architect
...shareholders, partners and communities. Visit us at Are:A seasoned SAP data migration leader who thinks in blueprints and delivers at scale.... ...migration platforms.A minimum of 5 years of experience managing cross-functional delivery teams in a program or workstream lead...
Full time
Work experience placement
Live in
Work at office
Local area
Accenture
Charlotte, NC
1 day ago
Senior Data Team Lead (Remote)
$86.8k - $217.1k
IQVIA is growing! Hiring multiple Senior Data Team Leads across our FSP (Functional Service Provider) and Traditional... ...experienced Senior Data Team Leads to oversee end-to-end data management delivery for global clinical trials. You’ll ensure quality, accuracy, and compliance...
Full time
Part time
Immediate start
Remote work
Work from home
Worldwide
IQVIA
Charlotte, NC
16 hours ago
SAP Master Data Governance (MDG) Lead
...about Accenture's SAP practice.You Are:You have a passion for storytelling and for originating, selling and delivering SAP-based Data Management and Analytics Transformation projects that make a positive impact in your clients’ business? Are you inspired by working with...
Full time
Work experience placement
Live in
Work at office
Local area
Accenture
Charlotte, NC
4 days ago
Optical Fiber and Cable Data Management Organization Manager
$126.9k - $174.49k
...Corning worldwide. Role Purpose Lead the Global OFC Data Maintenance Organization (DMO), ensuring accurate, consistent,... ...of experience in manufacturing, supply chain, operations, data management, data governance, or a related field. ~ Experience with SAP ERP...
Full time
Worldwide
Corning
Charlotte, NC
7 days ago
Sourcing and Procurement Data & AI Senior Manager
...Engineering, and Talent, with advanced capabilities in AI and Data, Industry and Process, and Technology. We serve approximately 9... ...how to take major leaps forward in cost-out, strategic category management, and procurement operations. You are:A Sourcing and Procurement...
Full time
Contract work
Work experience placement
Live in
Work at office
Local area
Accenture
Charlotte, NC
2 days ago
Data Lead Architect- Institutional Division
...Description:This role serves as the technical counterpart to the Data Steward, Director, and is responsible for the assessment and... ...documented frameworks, or architectures, which describe and are used to manage the implementation of a technical environment.System Design &...
Full time
Flexible hours
Pacific Life Insurance Company
Charlotte, NC
1 day ago
SAP Business Data Cloud (BDC) & Joule Manager
..., shareholders, partners and communities. Visit us at .You Are:As a Manager within Accenture's SAP Analytics practice, you will lead delivery teams and client engagements centered on SAP's modern data and analytics platform — including SAP Datasphere, SAP Analytics Cloud...
Full time
Work experience placement
Live in
Work at office
Local area
Accenture
Charlotte, NC
1 day ago
Snowflake Finance Data & AI Architect Manager
...helps drive value along the Finance Transformation journey.Recruiting for this role ends on 09/30/2026Work you'll doAs a Finance Data & AI Manager specializing in Microsoft Azure and Fabric, you’ll lead teams that design end-to-end solutions from source integration and...
Local area
Visa sponsorship
Deloitte
Charlotte, NC
2 days ago
Finance AI Data Strategy Manager
We Are:Our Finance AI and Data Strategy practitioners work to create and execute an organization’s business strategy for Finance AI... ...funded and a roadmap that gets built.5+ years of hands-on data management and analysis, paired with the strategic instinct to know which...
Full time
Work experience placement
Live in
Work at office
Local area
Night shift
Accenture
Charlotte, NC
1 day ago
Manager, Data Governance
...services and industrial parks as well as technology-driven customer solutions.We are seeking a strategic and execution-oriented Manager, Data Governance to support the definition and implementation of data governance initiatives with a strong focus on enabling AI, machine...
Local area
Worldwide
P&O
Charlotte, NC
4 days ago
Senior Enterprise Data Risk Oversight Manager
$170k - $200k
...in driving the successful implementation of the LoD2 Enterprise Data Risk Oversight Program across the Enterprise Data Office (EDO)... ...developments, and to translate those insights into forward-looking risk management practices, governance enhancements, and team-wide capability...
Full time
Contract work
Part time
Work at office
Shift work
Day shift
Truist
Charlotte, NC
2 days ago
Data Domain Governance Lead
...Data Domain Governance Lead All IT Solutions United States · Charlotte, North Carolina Workplace Type — Remote Employment... ...candidate will bring deep expertise in data architecture, metadata management, privacy compliance, and data quality, enabling scalable and...
Contract work
Temporary work
Local area
Remote work
3 days per week
All IT Solutions
Charlotte, NC
16 days ago
Data Sustain Lead
...operations and L2L3 sustain support of the Customer Customer Marketing Data Layer data platform including automated monitoring incident triage DQ checks ETLpipeline troubleshooting and knowledge management The engineer will operate against the target sustain state...
Permanent employment
Shift work
Zuven technologies Inc
Charlotte, NC
3 days ago
Data Sustain Lead
...operations and L2/L3 sustain support for the Customer Marketing Data Layer platform - Monitor data pipelines and marts, perform health... ...jobs - Track SLAs for scheduled and ad-hoc processes - Manage and triage incidents using ServiceNow, ensuring adherence to...
Permanent employment
Shift work
Expert Technology Services
Charlotte, NC
3 days ago
Marketing Data Enablement Manager
$155k - $200k
...Job Title: Marketing Data Enablement Manager Location-Type: Onsite, multiple locations available: Memphis, TN; Charlotte, NC; Raleigh, NC; New Orleans, LA; Birmingham, AL; Nashville, TN; or Miami, FL Start Date: ASAP Duration: Permanent Compensation Range...
Permanent employment
Full time
Immediate start
Mondo
Charlotte, NC
a month ago
Data Quality Manager
...Job Title: Data Quality Product Owner (Enterprise Data Governance) Location: Charlotte, NC Experience: 7-10+ Years Job Summary... ...through training, coaching, communication, and change management initiatives. • Develop and deliver presentations for Data Stewards...
IntraEdge
Charlotte, NC
2 days ago
Data Center Project Manager
Job Description We are seeking a Data Center Project Manager who is looking for an opportunity to grow and take on more responsibility, in any of our Deweberry offices. Our growing, fast-paced site/civil engineering practice seeks a client focused, highly motivated, organized...
Work at office
Local area
Dewberry
Charlotte, NC
4 days ago
Data Center Construction Manager
...engineers, scientists, digital innovators, program and construction managers and other professionals delivering projects that create a... ...Preferred Qualifications:Experience with hyperscale mission critical/data center construction projects.PMP or similar certifications...
Contract work
For contractors
Second job
Work at office
Local area
Worldwide
Relocation
Flexible hours
AECOM
Charlotte, NC
4 days ago
Data Center Project Manager *
...how you could help make great things possible not only in your community, but around the world. HDR is currently seeking a Data Center Project Manager to join one of the largest, fastest growing, and comprehensive TMT (Tech, Media and Telecom) practices in the...
Contract work
Work at office
Local area
HDR
Charlotte, NC
16 hours ago
Executive Director, Data Governance Lead
...Executive Director, Data Governance Lead About the Company Influential life & health reinsurance firm Industry Insurance... ...ensure that data is trusted, secure, compliant, and effectively managed. The role involves close collaboration with business and technology...
Confidential
Charlotte, NC
1 day ago
Data Quality Lead
...check us out at Job Description Candidate MUST have directly managed employees; providing mentoring, coaching and professional development... ...of experience in writing rules, configuration and profiling data using IBM Information Analyzer (or equivalent toolset) Hands-on...
For contractors
Mindlance
Charlotte, NC
16 hours ago
Data Privacy Delivery Lead
$97.6k - $170.04k
Sr Data Engineer - GE07BESr. Consultant, Asset Owner - GF07AEWe’re determined to make a difference and are proud to be an insurance company... ...future. The Hartford is seeking a Data Privacy Delivery Lead to manage the execution and continuous improvement of enterprise Data...
Full time
Temporary work
Work at office
Immediate start
Remote work
3 days per week
The Hartford Financial Services Group
Charlotte, NC
1 day ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Clinical Data Manager. Be the first to apply!