Everest Clinical Research · 3 weeks ago
Senior Clinical Data Manager
United States
Full-time
Remote
Senior Level
$115K/yr - $130K/yr
5+ years expEverest Clinical Research is a full-service contract research organization providing expertise-based clinical research services to the pharmaceutical, biotechnology, and medical device industries. They are seeking a Senior Clinical Data Manager to lead data management activities, perform client relationship management, and ensure high-quality deliverables for assigned projects.
Pharmaceutical
Responsibilities
Develop and maintain Data Management Project Plan (Plan). Document deviations from the Plan, log and report issues, and follow up on their resolutions
Is the primary contact person for day to day data management activities, and is the person ultimately responsible for all data management deliverables for assigned projects
Is the primary contact person for communication and discussion of topics related to data management timelines and deliverables; request for out of scope tasks; first line contact for technical or procedural issues
Is responsible for planning and implementing data management timelines and deliverables; and is responsible for providing database and data management activities status reports; contributes to the overall project planning, progress tracking and reporting
Assist with study-level resource planning and management, including the review of team members’ timesheet reports
Assist in performing client relationship management activities. Participate in project bid defense meeting when required
Perform training on electronic data capture (EDC) system, dataflow and quality control processes to clinical trial personnel
Provide training to new data management personnel on data management processes and procedures. Perform QC review of work performed by less experienced data management personnel
Assist in generation of project Work Orders and Amendments
Assist in management of dataflow from and performance of Third Party Vendors (Non-CRF data vendors)
Participate in project kick off meeting, investigators meeting, and regular project management team meeting
Provide support to client audits and regulatory inspections. Follow up on audit findings
Create and maintain clinical trial Data Management Study Binders
Design and review case report forms (CRFs/eCRFs). Develop and review Case Report Form Completion Instructions. Generate and review annotated Case Report Forms
Design and review Clinical Trial Source Document templates and completion instructions when required
Develop and maintain data validation specifications
Develop and maintain Data Management Plan (DMP). Document deviations from the DMP
Participate in the database design process. Participate in EDC User Acceptance Testing (UAT)
Manage the process of database modifications (after go-live) due to protocol amendments or study needs
Develop and maintain Data Quality Review Plan (DQRP). Coordinate with programmers to complete the programming and validation of the listings and summary tables as specified in the DQRP
Perform Third Party non-CRF data management activities
Review data, issue and resolve queries. Assist Investigative Site personnel with resolving queries
Perform Serious Adverse Event reconciliation
Assist in resolving medical coding discrepancies resulting from coding of medical history, adverse events, procedures and medicinal products
Cooperate and assist the Quality Assurance Department with quality control audits on assigned databases
Perform database soft-lock and hard lock activities
Maintain and prepare final archival of data management documentation relevant to the assigned clinical trials, and assist the corporate archivist in assembling and archiving such documentation
Qualification
Required
A Bachelors' or Master's degree in health and/or pharmaceutical sciences, physical/biological, or chemistry fields
At least 5 years of experience in pharmaceutical clinical trial data management or at least 2 year of experience as a Clinical Data Manager II, with demonstrated knowledge, experience and ability to perform to meet high quality standards and high level of customer satisfaction
Demonstrated an in-depth understanding of clinical trial data management concepts, processes and procedures, relevant issues related to or impacting clinical data management, as well as pharmaceutical clinical trial regulations, industry guidance, conventions and standards
Demonstrated a strong leadership in clinical data management activities and a desire to excel in leading data management projects
Company
Everest Clinical Research
Everest Clinical Research is a firm which conducts clinical research by contract for firms across the globe in fields
501-1000 employees
H1B Sponsorship
Everest Clinical Research has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (4)
2023 (4)
2022 (3)
2021 (1)
Funding
Current Stage
Late StageTotal Funding
$0.1MKey Investors
FedDev
2020-12-07Acquired
2019-08-18Grant· $0.1M
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