Previous Job
Previous
Sr. Project Manager – Data Operations
Ref No.: 18-12688
Location: Woodcliff Lake, New Jersey
Start Date / End Date: 10/15/2018 to 10/14/2019
Sr. Project Manager – Data Operations

• 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.


Qualifications:
• 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