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Senior Project Manager
Ref No.: 18-53997
Location: Woodcliff Lake, New Jersey
Position Type:Contract
Start Date / End Date: 10/15/2018 to 10/14/2019
Sr. Project Manager – Data Operations
Woodcliff Lake, NJ
06 Months

Job Description
• Project planning, budget estimation, resource allocation for the projects in database and other areas of programming related to clinical trials within Data Operations group in Oncology Business Group.
• Ensure all the database design, edit check programming, other areas of programming, QC, and related documentation preparation are conducted according to the established timeline and allocated resources.
• Ensure preparation of external data specification, data transmission, and testing is conducted as per the established timeline.
• Coordinate and track the activities for programming and technical support related to clinical trials, end users, and troubleshooting with quality and efficiency.
• Recognize turning points in a project and demonstrate good judgment in escalation, re-planning, stopping or entirely changing an approach.
• Propose, create and manage budgets with rolling estimates.
• Work with Data Operations Managers and the Clinical Project Team members for any Timelines and budget related activities.
• Provide submission related timelines support for data operations groups.

• Strong skills required in project management, Microsoft Project and other Microsoft Office products
• Knowledge of programming in the areas of Oracle's EDC system, SAS, Excel Macros, etc.
• At least 7 years of experience in programming / project management with at least 3 years with project management in clinical trials area within pharmaceutical/biotechnology companies in developing/managing clinical database design and related technical solution.
• Strong experience in SDLC process and Implementation.
• Demonstrated capabilities in supporting operational aspects of clinical study activities.
• Understanding of standards specific to clinical trials mainly in Oncology area. Good understanding of programming process, external data transfers, Coding dictionaries.
• Knowledge of IRT, Central Coding, IReview / JReview, Clintrial, SAS is a plus
• Knowledge of clinical data management process, clinical data entry, coding process, external vendor data processing,
• Excellent communication, organization and tracking skills with involvement in cross-functional, multicultural/international teams
• Proven ability to work either independently or in a team setting, and to prioritize and organize work to meet set deadlines
• Good understanding of clinical data handling process in Oncology area
• Strong analytical skills, handling multiple projects simultaneously.
• Experience with end users support, Team player, Good organizational and time management skills
• Capable to work with multiple groups simultaneously, strong communication skills
• Knowledge of Regulatory Guidelines in terms computer system validation, 21 CFR part 11,GCP, computer system validation

Interested candidates can send their updated resumes on and you can also reach me at 973-967-3431.

Artech Information Systems LLC.