Everest Clinical Research Services,CRO,Clinical Trial,Biostatistics,Programming,Data Management,IWRS,Pharmaceutical,Statistical,Analysis,Inform,SAS,Therapeutic,EDC,Study Portal
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Everest Clinical Research Services Inc. ("Everest") is a contract research organization providing statistical, data management, clinical trial monitoring and medical writing services to pharmaceutical and biotechnology companies. We serve some of the best-known companies worldwide, and work with many of the most advanced drugs in development today. Our Corporate Headquarters is in Toronto (Markham), Ontario, Canada with U.S. operations in the Little Falls (Greater New York Area), New Jersey, USA. As we continue to expand our business, we are currently seeking highly qualified and motivated individuals to work at our Markham and New Jersey offices as CLINICAL DATABASE DESIGN SPECIALIST.


Key Responsibilities:

Assists the Manager and Director, Clinical Data Management in planning, directing, and managing the clinical database design and maintenance process

Reviews the protocol and associated reference material and develops the database design project timeline. Maintains database design timelines. Promotes good project management practices. Consults with the Manager and Director and plans resource allocation and assigns employees to projects/tasks.

Follows up on regulatory requirements, industry trends, benchmarks, and best working practices in data management and database design by reading, participating in relevant training and/or association activities.

Design and review case report forms (CRFs/eCRFs).

Author and review the Edit Check Specifications for assigned projects.

Author and Review the User Acceptance (UAT) test plan. Oversee the User Acceptance Test process.

Author and maintain procedural documents (SOPs, Work Instructions, Templates and Checklists) for database design and testing.

Provides input to all data management procedural documents.

Review the Data Management Plan (DMP) for assigned projects.

Review data, issue and resolve queries. Assist the Clinical CRO, sponsor or Investigative Site with resolving queries.

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. Validate and disseminate real-time study monitoring reports to sponsor and internal team members.

Define and monitor clinical trial data flow and quality control processes in accordance to corporate SOPs, Good Working Practices, and unit guidelines.

Provide training to study site and sponsor personnel on data entry and review (electronic data capture studies), data flow and quality control processes. Accurately and efficiently validate electronically captured data. Write clear queries on missing data and data points failing pre-defined range checks and/or logical checks.

Qualifications and Experience:

A bachelors' or masters’ degree graduate in health science, physical or biological fields along with a post graduate diploma in clinical research studies. The incumbent must have a minimum of 5 years experience in clinical trial data management and database design. Demonstrated leadership ability to effectively manage clinical trial data management and database development activities and integrate them with the entire clinical trial.

Must have experience designing Inform clinical databases and knowledge of other electronic data capture systems and processes. Solid understanding of clinical drug development process and knowledge of FDA regulatory requirements and ICH/GCP guidelines is required.

The successful Candidate must have great service acumen with excellent oral and written English communication skills, with the ability to apply such skills in logical and algebraic operations.

We are an equal opportunity employer. We thank all interested applicants; however, only those selected for an interview will be contacted.

How to Apply

Please send your application, indicating the position to which you are applying to careers@ecrscorp.com.

Posting Date: January 6, 2014

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