Clinical Application Specialist Bd
Franklin Lakes, NJ

Job Description

Job Description SummaryThe Clinical Application Specialist (CAS) for the Clinical Trial Management System (CTMS) is a key & vital BD associate within the Medical Affairs (MA) / Global Clinical Development (GCD) organization and works closely with other GCD associates and various other BD associates from the Business Units throughout the conduct of clinical studies. The CAS CTMS is the primary person responsible for the continued development, support, maintenance, training and promotion of user adoption of the current and future CTMS.

The CAS CTMS ensures the CTMS enables maximum business processes, efficiencies, and promotes best CTMS practice across GCD, Business Units and Regions. The CAS CTMS drives process improvement initiatives to completion and fosters knowledge sharing across all levels of the BD organization. The CAS CTMS interacts with the larger Global Services group (IT) and Global Information Security (GIS) departments to ensure that CTMS and other Clinical Applications are maintained in compliance with industry and company standards.

Job Description

* Provides input into the development of CTMS and other Clinical Application standards, policies, and procedures.
* Ensures that the design and use of CTMS and other Clinical Applications adhere to established policies, procedures, and standards.
* Works with GCD, Business Units and Regions to implement CTMS best practice, standardization, utilization and optimization.
* Provides timely and expert level support and troubleshooting of issues impacting CTMS.
* Contributes to solutions for routine technical problems and liaises with software vendors, hosting partners, IT and GIS as appropriate to resolve issues.
* Maintains all required system and study level (as applicable) documentation.
* Ensures a comprehensive and well documented risk based approach is taken to system change control; validation documentation is compiled, archived and "audit ready" for all system upgrades, enhancements, patches, etc.
* In collaboration with the Manager of Clinical Analytics, facilitates the identification and capture of meaningful and actionable metrics to continuously evaluate performance and promote data driven decision making.
* Through the use of technology/dashboards ensures transparency of information across the organization.
* Performs user account management activities.
* Delivers clear and concise communication of planned and unplanned disruptions in service to affected end users.
* Actively works to promote end user adoption, acceptance and active user community dialogue.

EDUCATION:

* BA / BS computer science/information technology or life sciences from a 4 year accredited university.
* Proficient computer skills across multiple clinical trial applications.
* Advanced knowledge of Microsoft applications including Outlook, Excel, Power Point, SharePoint, Visio and Word.

EXPERIENCE:

* Minimum 3 years working in a clinical research environment.
* Minimum 3 years managing a Clinical Trial Management System (CTMS) either from sponsor or vendor perspective. Hands on experience with commercial off the shelf (COTS) CTMS
* Experience with reporting and/or business intelligence tool desired.
* PL/SQL, SQL scripting highly desired.
* Intermediate knowledge of IT networking and security principles.
* Experience with development, validation, execution, maintenance, documentation, and archival of clinical data targeted for regulatory submission desired.

Additional Desirable Qualifications, Skills and Knowledge:

* Experience and comfort in working both independently and as part of a multifunctional team.
* Ability to manage multiple deliverables concurrently.
* Strong working knowledge of GCP/ICH regulations and guidelines.
* Excellent interpersonal skills, strong written and verbal communication skills.
* Working knowledge of clinical development.
* Working understanding of techniques of clinical trial principles.
* Ability to interact effectively within and across team environment.
* Promotes knowledge sharing in the group.

Primary Work LocationUSA NJ - Franklin Lakes

Additional Locations

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