Hired by Matrix, Inc. Senior Project Manager in Woodcliff Lake, New Jersey
Senior Project Manager
Job Location:Woodcliff Lake
Work with IT and clinical teams in the development and support of Global Clinical Data Management, Clinical Pharmacology, and Biostats Systems within this human health care pharmaceutical company.
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 Company 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.
Minimum 5-7 years’ experience as Project Manager and at least 3+ years 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 preferred.
Please submit your resume for consideration. Once submitted, feel free to contact Sanka at 646-856-8903 for additional information.
Approx. Duration: 12 months
About Hired By Matrix
Hired by Matrix, Inc. founded in 1986, is a certified Woman-Owned Business Enterprise (WBE) dedicated to providing the highest quality of job opportunities to our candidates and staffing services to our clients. We are a full service staffing firm with experience recruiting and delivering for IT, Accounting & Finance, Administrative & Clerical, Clinical & Scientific, and Marketing disciplines. Our long history in the staffing industry and dedication to excellence are the key differentiators that have fueled our success for over 30 years.
As the staffing industry evolves, Hired by Matrix continues to develop and grow. By combining our expertise with a keen understanding of each client’s needs we are able to source for the most qualified candidates. Our commitment to servicing our clients corresponds with our commitment to finding the perfect match between our clients and candidates and maintaining our relationships long term.
Hired by Matrix offers our contract professionals competitive salaries, benefits after 60 days and a 401k option after one year.Equal Opportunity EmployerWBENC CertifiedWOSB Certified*CEO Sharon Olzerowicz serves on the WBENC Board and is a long-standing member of the Forum Governing Group.
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