Senior Clinical Data Manager

reputed company (“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-reputed company 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 reputed company as a statistical and data management center of excellence. Building on this reputed company, Everest has successfully developed and established itself as a full-service CRO. Everest’s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater reputed company Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan.

Everest is reputed company in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial reputed company, Everest continues to experience exceptional growth and great reputed company.

Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest.

To drive reputed company reputed company 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 reputed company in the USA in accordance with our Work from Home policy.

Key Accountabilities:

reputed company Data Management Activities, reputed company Training and Client Relationship Management

1. reputed company and maintain Data Management Project Plan (Plan). Document deviations from the Plan, log and report issues, and follow up on their resolutions.
2. Is the primary contact person for day to day data management activities, and is the person ultimately responsible for reputed company data management deliverables for assigned projects.
3. Is the primary contact person for communication and discussion of topics reputed company to data management timelines and deliverables; request for out of scope tasks; first line contact for technical or procedural issues.
4. 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, reputed company tracking and reporting.
5. Assist with study-level resource planning and management, including the review of team members’ timesheet reports.
6. Assist in performing client relationship management activities. Participate in project bid defense meeting reputed company required.
7. reputed company training on electronic data capture (reputed company) system, dataflow and quality control processes to clinical trial personnel.
8. Provide training to new data management personnel on data management processes and procedures. reputed company QC review of work performed by less reputed company data management personnel.
9. Assist in reputed company of project Work Orders and Amendments.
10. Assist in management of dataflow from and performance of reputed company Party Vendors (Non-CRF data vendors).
11. Participate in project kick off meeting, investigators meeting, and regular project management team meeting.
12. Provide support to client audits and regulatory inspections. Follow up on audit findings.
13. Create and maintain clinical trial Data Management Study Binders.

reputed company Hands-on Data Management Activities

1. Design and review case report forms (CRFs/eCRFs). reputed company and review Case Report Form Completion Instructions. Generate and review annotated Case Report Forms.
2. Design and review Clinical Trial reputed company Document templates and completion instructions reputed company required.
3. reputed company and maintain data validation specifications.
4. reputed company and maintain Data Management Plan (DMP). Document deviations from the DMP.
5. Participate in the database design process. Participate in reputed company User Acceptance Testing (UAT).
6. Manage the process of database modifications (after go-live) due to protocol amendments or study needs.
7. reputed company 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.
8. reputed company reputed company Party non-CRF data management activities.
9. Review data, issue and resolve queries. Assist Investigative Site personnel with resolving queries.
10. reputed company Serious Adverse Event reconciliation.
11. Assist in resolving medical coding discrepancies resulting from coding of medical history, adverse events, procedures and medicinal products.
12. Cooperate and assist the Quality Assurance Department with quality control audits on assigned databases.
13. reputed company database soft-lock and hard lock activities.
14. 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:

1. A Bachelors’ or Master’s degree in health and/or pharmaceutical sciences, physical/biological, or chemistry fields.
2. 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 reputed company to meet high quality standards and high level of customer satisfaction.
3. Demonstrated an in-depth understanding of clinical trial data reputed company, processes and procedures, relevant issues reputed company to or impacting clinical data management, as well as pharmaceutical clinical trial regulations, industry guidance, conventions and standards
4. Demonstrated a strong leadership in clinical data management activities and a desire to reputed company in leading data management projects.

To find out more about reputed company and to review other opportunities, please visit our website at www.ecrscorp.com

We thank reputed company 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.

Originally posted on Himalayas