Long-term Contract with Pharmaceutical firm in NJ
Work with IT and clinical teams in the development and support of Global Clinical Data Management, Clinical Pharmacology, and Biostats Systems. Plan and coordinate system design criteria, development, implementation, maintenance, and support of new or upgrades of existing systems. Provide technical expertise to the project teams via developing complex specification documents, data & process flow diagrams and assist in the creation of all required validation documentation. Work with business users, IT teams and Validation specialists in implementation testing, and evaluating upgrades to technologies, including systems validation, SOP / SWP creation and end user training. Responsible for making sure that GxP as well as quality standards are followed in the implementation and controlled changes to supported systems.
The IT PM will be responsible for coordinating resources within various groups, establishing and maintaining project plans and timelines, taking into account resource, technical, vendor and budgetary constraints. The PM will schedule and conduct routine project team meetings to coordinate and drive the project team activities through to completion. The PM will also be expected to serve as technical / process guide to the business members by providing expert direction, review of deliverables and problem solving / analytical skills to work out process and logistical problems.
Bachelor’s Degree Required
PMP certification a plus.
Min 5-7 years’ experience as Project Manager and at least 3+ year’s implementing / supporting Clinical IT applications in the areas of Clinical Data Operations, Clinical Data Management, Biostatistics or Clinical Pharmacology.
Extensive knowledge of Pharma Data flow and Application use & integration within the drug development processes from Protocol design through FDA Submission.
Experience working in a GxP environment is required.
Experience with MS Project, Visio, and Excel, PowerPoint
The Sr. PM needs to understand drug development in Phase II and Phase III from protocol design to submission
Sound understanding of I.T. processes, Software Development Life Cycle methodology and Quality Management with the ability to apply those principles
Strong analytical and problem solving skills, attention to detail
Self-motivated, goal-oriented with the ability to work independently
Good oral and written communication skills with the ability to communicate with both technical and business groups.
Validation and documentation experience
Systems of interest include:
J-Review , Oracle, Oracle LSH, SAS, SAS GRID, Oracle InForm, R, WinNon-lin, Pheonix, NONmem,and or other related clinical database systems. Experience with SAAS solutions a plus.