Principal Application Specialist

Company Name:
Full-time Position
Principal Application Specialist
Fort Lee, New Jersey
A General Overview of the Position

The person who wins this position will perform complex managerial, planning, and technical tasks supporting corporate clinical development systems (CDS.

The role will require the individual to wear three hats, that of the business analyst, project manager, and application support specialist, in advancing new CDS implementations, including an electronic Trial
Master File (eTMF).

The position will report directly to the Senior Director of IT R&D Systems and will be the primary liaison between clinical development and IT.

The Specific Duties that Come with This Position
Coordinating project activities between two development centers, one in New Jersey, the other in Massachusetts.
Managing the systems support and systems development teams.
Planning and managing projects through their lifecycles by developing comprehensive project plans.
Planning capacity.
Managing budgets.
Overseeing data integrity
Managing consultants and vendors.
Troubleshooting all areas of the CDS environment.
Coordinating with end users in the interest of planning projects, prioritizing system requests, and providing status updates.
Ensuring that project tasks and deliverables meet requirements and are completed on schedule and within budget.
Overseeing project communications to ensure on-time updates are provided to all stakeholders.
Identifying, mitigating, and resolving project risks and issues.
Developing project plans (with schedules and resource requirements) for upgrades and new implementations.
Ensuring that systems meet all regulatory requirements, both domestic and foreign.
Working with other clinical development staff to address system and data requirements.
Working with delegates from global sites to plan for future system needs, and budget requirements.
Coordinating system interfaces so that processes work well and efficiently together.
Working with external vendors at all levels to maintain system operation and timely data exchanges.
Reviewing, evaluating, and recommending new software applications to meet the business needs of the clinical development department.
Planning for future strategic requirements.
Monitoring daily system operation and assisting users in producing and submitting documents related to system operation, as necessary.
Collaborating with IT to maintain system performance, system security, and CFR Part 11 compliance.
Managing and maintaining system validation activities at all sites for software upgrades, implementations, and integration projects.
Escalating problems to source vendors when data source files are not received on time.
Diagnosing the causes of production job failures and communicating to all customers the steps for issue resolution.
Documenting application issues and solutions.

The Technical ?Toolkit? and Proficiencies You Must Have to be Considered

A fundamental working knowledge of CFR Part 11.
Oracle Siebel.
Siebel CTMS
Medidata Rave ECTD
ClinApps PMD.

The Work History You Either Must Have or Would be a Plus to Have

At least five (5) years of relevant work experience in the pharmaceutical industry
Must have worked with commercially available, clinical development systems.
Must have worked with validated CTMS, eTMF, eCTD applications.
Must have worked in environments where engagement with information systems or issues in computer science was routine.

The Educational Background You Need to be Considered

BS/BA in a science, engineering, or business field.

General Characteristics and Aptitudes You Must Have to Be Considered

Must be able to organize, work on, and communicate about multiple projects simultaneously with a high attention to detail.
Must be organized and reliable.
Must be able to express complex technical concepts effectively, both verbally and in writing.
Must be able to make decisions.
Must exhibit sound judgment.
Must be able to develop and complete assigned projects on time.
Must be able to work effectively in a team environment.
Must be able to cultivate effective working relationships with peers, supervisors, vendors, and consultants, who will have varying degrees of technical knowledge.
For more information, please email Frank Paparelli Technical Recruiter:

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