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Senior Clinical Data Manager


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Senior Clinical Data Manager
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Job Title: Senior Clinical Data Manager
Location: Bedminster, NJ Zip Code 07921
Duration: 6 Months (Contract with possible extension) on W2

The individual will be part of the Research and Development Group (RD) which is responsible for all FDA related research and supports all non- FDA company sponsored research.

The team allows 1 day of working from home, after training/when company deems it is appropriate to begin.

Primary Job Responsibilities:
Create and review (electronic) Case Report Forms per Protocol and annotated Case Report Forms
Review Protocols to ensure database feasibility
Develop/build, review, and maintain a clinical database and supporting specifications documentation
Develop/build, document and perform validation of database structure, data capture screens, code lists, edit checks, reports and other functions in EDC (e.g. User Acceptance Testing)
Develop data transfer agreements and specifications with variousvendors
Write, review and maintain eCRF completion guidelines, data management plan (DMP), data validation plan (DVP, e.g. edit checks), and other DM related documentation
Perform all aspects of DM process as related to processing and QC of the data
Clean data for study close out and perform all database lockprocedures
Manage reconciliation with any external data (e.g. SAE, lab)
Monitor study status (e.g. enrollment, CRFs, etc.) and provide status reports to the team
Use standard conventions, tools, references and process in support of the coding of medical terms
Ensures all DM procedures executed with a high attention to detail, accuracy and timelines
Represent the DM function on project teams
Write and review DM SOPs in accordance with GCP and ICH guidelines, and develop associated training and competency testing
Maintain CRFs m1d database standards
Work in conjunction with Clinical Operations, Clinical Research, and other operations to ensure accurate, efficient, and complete datacollection
Mentor junior level staff on database management tasks andprocesses
Contribute/participate in data management initiatives
Other duties as assigned

Computer Skills:
Proficient in Microsoft Office applications (PowerPoint, Microsoft Word, Microsoft Excel, etc.), Internet software, E-mail
Proficient with Clinical Data Management Systems (CDMS) and experience with Electronic Data Capture (EDC) systems
Experience with SAS (Base, Stats, Macro, etc.)
Experience with CDISC SDTM/CDASH
Experience with study database build (including edit check programming)
Experience in software development, software implementation, testing and validation

Education and Experience Required:
B.S. in Mathematics/Statistics, Computer Science, Life Sciences or related field
Minimum 8 years of data management experience in the pharmaceutical or biotechnology industry
Highly organized and detail-oriented with effective planning with strong verbal and written communication skills
Flexibility mi1d agility to adapt to changing scope of work, able to propose thoughtful solutions to challenges and issues, proactively implement solutions, and communicate effectively with colleagues
Experience/knowledge of GCP and ICH guidelines

**MEMBERS ONLY**SIGN UP NOW***. (SSI) is an IT, Health Care, and Engineering Services Consulting firm established in 2000. SSI consultants have provided exceptional services at over 50 Fortune 500 companies, as well as 100s of small and mid-size enterprises.
Also, as a perk to our recruiting process, you are also now enabled to create your own profile at JOBMA. (****This proprietary video recruiting platform enables greater visibility for our candidates by allowing Job Seekers to speak for themselves. Cast your net to a larger hiring audience by creating your video resume profile.

Best Regards.

Rohit Ahlawat, Technical Recruiter
HQ: 13911 Ridgedale Drive, Suite 230
Minnetonka, Minnesota 55305
( Work: 952-546-3300 ext. 6019, ( Cell: 651-204-7041 *: ****

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