Project Manager - Pregnancy Registries Team

Overview

Senior Project Manager serving as Project Lead and primary sponsor contact, accountable for overall delivery (quality, time, cost) of cross-functional projects of increasing complexity on the Pregnancy Registries Team.

What you'll do

• Serve as the primary contact between the sponsor and the organization at the project level.
• Ensure escalation pathways are adhered to internally and externally (Rules of Engagement – communication pathways).
• On projects where scope requires, ensure clear delineation of responsibilities and communication pathways for secondary project leads (such as lead in a specific region, lead for a specific vendor(s) or subset of delivery).
• Drive and own the overall delivery of the cross-functional project (time, cost, quality).
• Ensure financial stewardship at a project level by demonstrating an intimate understanding of the contract, resource alignment to budget, management of Out of Scope activity, driving the Con Mod process/negotiations and team execution to timelines.
• Establish, communicate and manage customer expectations to achieve optimal delivery during the project.
• Drive risk identification and issue resolution at project level (RBQM/RESOLVE).
• Ensure project team compliance with organization policies, SOPs, ICH-GCP, regulatory and project-specific requirements.
• Act as a mentor.
• Develop or contribute to process improvement initiatives.

What you'll need

• Experience working with Pregnancy Registries is required.
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years').
• Technical and systems competency, such as computer skills, to include effective use of Microsoft Outlook, Word, Excel and PowerPoint, as well as organization systems (CTMS, Preclarus, Clarity).
• Ability to delegate and effectively prioritize workload and resources for project team members in a frequently changing environment.
• Effective oral and written communication and presentation skills.
• Proactive, solutions oriented and adaptable in changing priorities and situations.
• In-depth therapeutic area knowledge and clinical development guidelines and directives.
• Advanced knowledge of the key principles of cross functional project management (Time, Quality, Cost).
• Effective interpersonal skills, including the ability to lead, motivate and coordinate cross-functional project teams.
• Strong customer service skills with the ability to proactively address and prioritize expectations.
• Good judgment and decision making skills and proven ability to apply critical and analytical strategic thinking to manage complex/ambiguous situations.
• Strong negotiation skills with ability to influence others and achieve results, including cross cultural awareness.
• Strong financial acumen with the knowledge and ability to minimize risk by proactively managing and adjusting budgets/forecasts/resources.
• Ability to work independently with minimal supervision.

Details

• Work schedule: Standard (Mon-Fri).
• Location: Remote, North Carolina, USA.
• Working conditions: work is performed in an office/laboratory and/or clinical environment; exposure to biological fluids with potential exposure to infectious organisms; exposure to electrical office equipment; personal protective equipment required such as protective eyewear, garments and gloves.