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Senior Clinical Data Manager - Bridgewater, United States - Everest Clinical Research
Description
Everest Clinical Research ("Everest") is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries.
We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.
Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence.
Everest's headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan.
Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients' needs.
Quality is our backbone, customer-focus is our tradition, flexibility is our 's 's Everest.
To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as
Senior Clinical Data Managers
for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA in accordance with our Work from Home policy.
Key Accountabilities:
Lead Data Management Activities, Perform Training and Client Relationship Management
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.
Perform Hands-on Data Management Activities
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.
Qualifications and Experience:
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 standardsDemonstrated a strong leadership in clinical data management activities and a desire to excel in leading data management projects.
To find out more about Everest Clinical Research and to review other opportunities, please visit our website
We thank all interested applicants, however, only those selected for an interview will be contacted.
Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity.
We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.
#LI-Remote#LI-KD1
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.
However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.
41 CFR c)#J-18808-Ljbffr
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