Senior Analyst, Firstdoc System

Yoh has a long term contract opportunity for a SENIOR (SR.) ANALYST/FIRSTDOC (FD) SYSTEM to join our client in Edison, New Jersey.

JOB OVERVIEW:

This person is responsible for all duties associated with supporting and managing the Electronic Document Management System (EDMS - FirstDoc system) and ensuring completeness of electronic Trial Master Files (eTMFs) for phase 1 thru phase 4 studies. This person will interact with a broad range of local and global functional groups, outside vendors, partners, and CROs to manage accounts administration, provide FirstDoc system support services, and deliver eTMF training to end users and the personnel of our outside partners. This is a key position in our effort to keep the Trial Master Files in an inspection ready state. In addition, the responsibilities include optimization, and training on the use of FD regarding its other TMF associated uses.

JOB RESPONSIBILITIES:

- Oversee, recommend and implement appropriate database solutions to enhance management and reliability of eTMF/e-collaboration solution (ie FirstDoc).
- Collect and review system data for capacity and planning purposes. Analyze capacity data and develop appropriate enterprise - wide solutions to ensure availability of the eTMF system for all users in various divisions.
- Perform moderately complex systems and database administration, and performance monitoring to ensure optimum level of performance for global use of FirstDoc.
- Oversee and apply appropriate support packages/patches to maintain system integrity.
- Oversees appropriate level software installations, upgrades and related software packages to maintain state of validation for the FirstDoc system.
- Support design and configuration changes of the FirstDoc system.
- Establish and chair a change control board.
- Plan, coordinate and direct appropriate data review strategies to ensure a functioning FirstDoc system for all regions.
- Establish and run Users Group among all regions.
- Develop and maintain appropriate system documentation to ensure continued state of validation.
- Oversee the maintenance of a library of system-supporting processes and procedures for data dictionaries associated with trials.
- For each new clinical trial work with functional groups to set-up studies in FirstDoc system.
- Provide leadership and work guidance to internal personnel and interacts with CRO staff to answer questions, triage problems and requests regarding system support issues with support vendors.

JOB QUALIFICATIONS:

- Bachelor's degree in computer science, management information systems, or related field preferred or equivalent combination of education and experience.
- Three to six (3 to 6) years of experience with FirstDoc Documentum R visit our website to learn more about our company. If you are seeking workforce solutions in the IT sector, see our comprehensive IT Staffing Resources.

Yoh, a Day J2W: CLINICAL

Tax Term: CON_W2J2WBRPHIL

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SFSF: LS