Clinical Data Manager

Found in: Appcast CA C2 Glassdoor - 1 week ago

Toronto, Canada SCiAN Services Full time


About SCiAN (www.scian.com)

SCiAN Services is a Contract Research Organization offering expertise-based services in the Biotechnology/ Pharmaceutical Industry.  SCiAN serves well known companies by providing high quality deliverables and superior customer service. For over 34 years we have embraced innovation when offering services in Pharmacovigilance, Biostatistics, Data Management and Custom Database Solutions. SCiAN’s therapeutic expertise includes immuno-oncology, gene therapy, CNS, infectious disease, autoimmune diseases and diabetes.

 

SCiAN Services offers employees exceptional opportunities for growth and exposure within the company itself. In your position, you will be introduced to all areas of expertise ranging from Biostatistics to Data Management to IT. SCiAN’s employees learn in a hands-on, personalized environment, and are able to achieve more as a result.

To support the Company’s growth, we are seeking to add Clinical Data Associates to our team. 


Summary

We are looking for a Clinical Data Manager to manage CDM projects and resources to ensure quality, accuracy and consistency of clinical data. In this capacity, you will ensure all processes are completed for interim and final DB locks and performs final QC checks. You will train, mentor and oversee the work of junior data management staff.



Responsibilities include:

·      Manage the CDM segment of studies: interface with Sponsor and 3rd party vendors, manage project CDM resources, ensures timely completion and quality of CDM deliverables.

·      Gather database design and configuration specifications from the Sponsor

·      Review DB designs to ensure consistency with protocol requirements

·      Review custom data validation rules and checks for completeness and logic

·      Performs UAT testing of database design and design updates, ensures all test documentation is complete prior to DB release

·      Author and update CDM control documents, including Data Management Plan, SAE reconciliation, Laboratory / PK reconciliation plans, etc.

·      Assess impact of protocol amendments on database design and recommend DB changes

·      Perform clinical study data review (non-medical reviews)

·      Review consistency of AE, medical history and medication coding

·      Ensure all processes are completed for interim and final DB locks and performs final QC checks

·      Provide CDM status updates to internal Project Manager and Sponsor

·      Manage data transfers from 3rd party vendors and to Sponsor or 3rd party vendors

·      Attend Sponsor team meetings

·      Liaise with the Biostatistics group

·      Participate in internal/external audits

·      Oversee the work of other CDAs as required. This may involve on-the-job training and ensuring the quality of work performed.

·      Train and mentor junior data management staff providing timely feedback to trainees and management as appropriate

 

Qualifications:

·      BSc. in Life Sciences preferred, or Bachelor degree with equivalent knowledge/experience

·      Minimum 5 years of experience in clinical data management

·      Experienced in managing CDM projects from design to database lock

·      Experience with EDC systems, including Medidata Rave

·      Knowledge and understanding of database build, testing and documentation

·      Experience in coding AEs, medical history and concomitant medications with MedDRA and WHODrug Global

·      Knowledge of SAS and Lotus Notes an asset

·      Excellent communication and interpersonal skills

·      Ability to work under minimum supervision


The candidates must be eligible to work in Canada.


To find out more about SCiAN Services and to review other opportunities, please visit our website at www.scian.com 


We thank all interested applicants, however, only those selected for an interview will be contacted.

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