Project Manager - FSP
PharmaBiotechClinical ResearchRegulatory AffairsQuality Assurancegcpcroctms
Job description
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Project Manager - Make an Impact at the Forefront of Innovation The Project Manager serves as the Project Lead and primary sponsor contact and is accountable for the overall delivery of the project (quality, time, cost) on behalf of the organization. Additionally, the Project Manager establishes and communicates customer expectations to the project team and ensures that escalation pathways are adhered to internally and externally. The role involves leading the cross functional project team to meet or exceed deliverables. What You'll Do: • Serve as the primary contact between the sponsor and the organization at the project level. • Ensure escalation pathways adhered to internally and externally (Rules of Engagement – communication pathways). • On projects where the scope requires, ensure clear delineation in 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). • Accountable for 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, drive 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. Education & Experience Requirements: • Bachelor’s degree or equivalent, supported by relevant academic or vocational qualifications. A master’s degree and a background in biomedical or life sciences are preferred. • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years’). Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions. Knowledge, Skills, Abilities: • Technical and systems competency, such as computer skills, to include effective use of systems and applications such as Microsoft Outlook, Word, Excel and PowerPoint, as well as organization systems (CTMS, Preclarus, Clarity) • Ability to delegate and effectively prioritize own and workload of project team members in a frequently changing environment • Effective oral and written communication and presentation skills • Proactive, solutions oriented and adaptable to changing priorities and situations • Advanced therapeutic area knowledge and clinical development guidelines and directives • Strong understanding of the key principles of project management (time, quality, cost), including solid financial acumen • Sound interpersonal and customer service skills, including the ability to lead, motivate and coordinate cross-functional project teams • Good judgment and decision making skills and capable of applying critical and analytical strategic thinking skills to manage complex/ambiguous situations • Ability to negotiate, persuade and influence others, including a cross cultural awareness. Working Conditions and Environment: • Work is performed in an office/ laboratory and/or a 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. What if your work could help advance innovative medicines for patients with some of the world's most challenging diseases? In this embedded PPD™ Functional Service Partnership (FSP) role, you'll contribute to a global biopharmaceutical organization committed to transforming scientific innovation into meaningful advances for patients. You'll work closely with the client’s clinical development teams, contributing to research across therapeutic areas such as oncology, respiratory diseases, obesity, eye health, cardiometabolic conditions, and other areas of significant unmet medical need. As a valued member of an integrated FSP clinical team, you'll build deep client and therapeutic expertise, collaborate with experienced colleagues, and take ownership of work that contributes to the development of potentially life-changing treatments. Bring your expertise, curiosity, and commitment to patients to an environment where meaningful science meets purposeful collaboration. Apply today!
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