Job Req #: 20-02103
Job Description: Sr. Project Manager, R&D IT
Location: Morris Plains, NJ
Position Type: 6-Month Contract
The Senior Project Manager is responsible for project management of R&D IT projects within the Clinical R&D business technology area, supporting Clinical Operations, Clinical Development, Regulatory, Pharmacovigilence and other related support functions. The priority and assignment of projects will be determined by the supervisor. The position is responsible for facilitating the assigned IT projects from end-to-end (assignment to conclusion). The Senior Project Manager works closely with the project team including business leads, SME’s, IT peers, validation and other team members to ensure proper functional implementation or change control to enhance operations.
The Senior Project Manager will work in partnership with the Head of R&D Business IT and the Head of IT PMO to develop and implement best practices, standardized templates and PM methodologies to be practiced within the organization.
• Assist with the review/approval of project vendor agreements and procurement activities.
• Assemble and kickoff the IT project team including cross functional members (i.e. IT, business function(s), vendor(s) and CQA).
• Develop the project charter and plan in conjunction with the project team.
• Manage the project budget, timelines and deliverables according to the project plan with any escalation to the project sponsors.
• Ensure that the project deliverables are aligned and adapted with business and IT strategy.
• Provide industry and domain specific best practices perspective and consultation to business and IT partners.
• Establish strong working relationships with business stakeholders to understand the evolving capabilities, business priorities and support activities to achieve them; be an engaged partner in the success of the business domains.
• Build effective working relationships and collaborate with other domain and enterprise resources to ensure customer needs are being met.
• Assist in the development of the IT PMO best practices.
• Promote collaboration and teamwork within the domain and across IT.
CORE COMPETENCIES (KNOWLEDGE, SKILLS, AND ABILITIES)
• Project Management: Ability to manage all facets of IT project management including, but not limited to, technical capabilities, user requirements, system integration/impact analysis, project planning, communication planning, issue management, milestone tracking, system validation/UAT, resource management, task management and risk management.
• Domain Knowledge: Understands the pharmaceutical/biotech industry and how it operates; Demonstrates strong domain knowledge and how technology solutions can improve or enhance existing processes and overall business results; well versed in global GxP and Computer System Validation practices; solid understanding of the regulatory environment and industry standards (i.e. ICH E6(R2), 21 CFR Part 11, Annex 11, GAMP 5, etc.).
• Vendor Management: Ability to negotiate and comprehend vendor agreements; know and understand vendor obligations and deliverables; manage consultants, vendor budgets and timelines.
• Dealing with Ambiguity: Can effectively adapt to change; is flexible and comfortable with working in an unpredictable, development environment; can manage risk and uncertainty with the interests of the team and the project.
• Multi-Tasking: Able to work on multiple, unrelated initiatives at the same time while maintaining accuracy and quality with deliverables; can see opportunities for synergy and integration across subject areas.
• Communication: Excellent written and oral communication skills; able to engage with multiple levels of the organization.
• Bachelors’ degree in Computer Science, Business or closely related field from accredited college or university, or equivalent experience
• Minimum of 8 years relevant work experience as a project manager, especially in the Biopharmaceutical industry including hands-on experience as a project manager of Clinical Development IT projects in support of global business operations
• Minimum of 5 years relevant work experience and business acumen in Clinical R&D within global pharmaceutical/biotech organizations
• Project Management certification (i.e. PMP) is preferred
• Strong operational knowledge with technologies and processes in one or more of the Clinical R&D functions: Clinical Development, Clinical Operations, Regulatory Affairs, Pharmacovigilance/Safety, Medical Affairs, Pre-Clinical and Chemistry
• Effective project and time management skills with demonstrated ability to meet deadlines
• Strong customer orientation and results focused with an attention to detail
• Cross-functional agility and the ability to thrive in a complex and dynamic environment
• Experience with SDLC, and computer system validation/testing
• Working knowledge of current Good Clinical Practices, Computer System Validation requirements (i.e. ICH E6(R2), 21 CFR Part 11, Annex 11 and GAMP 5)
• Familiar with emerging business process automation trends and tools
• Ability to prioritize and manage unrelated concurrent assignments
• Maintains direction and focus through proactive planning and organized work approaches
• Develops and implements innovative and creative solutions to business problems
• Communicates a 'can do' attitude and positive outlook, demonstrating initiative and resourcefulness
• Certification / experience in Operational Excellence / Six Sigma is a plus
**If this is not a fit for you or you are not interested, Ascent Services Group offers an excellent Referral Bonus! We look forward to hearing from you!
About Ascent: The Ascent Services Group (ASG) is a nationally recognized technology staffing and consulting firm whose fundamental business is providing staffing services to Small, Medium, and Large Enterprise clients in our core market verticals: Financial Services, Healthcare, Technology and Life Sciences. As consultants for ASG, you will have access to many of the top clients within the industries we serve. Our goal is to deliver innovative talent through proven best practices and effective resource optimization. Become one of ASG’s candidates and experience the difference!