Job Description
Summarized Purpose:
Serves as the Project Lead and primary sponsor contact. Accountable for the overall delivery of the project (quality, time, cost) on behalf of the organization. Establishes and communicates customer expectations to the project team. Ensures that escalation pathways are adhered to internally and externally. Leads the cross functional project team to meet or exceed deliverables.
Essential Functions and Other Job Information:
Essential Functions
• Serves as the primary contact between the sponsor and the organization at the project level.
• Ensures escalation pathways adhered to internally and externally (Rules of Engagement - communication pathways).
• On projects where the scope requires, ensures 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).
• Ensures 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.
• Establishes, communicates and manages customer expectations to achieve optimal delivery during the project
• Drives Risk Identification and Issue Resolution at project level (RBQM/RESOLVE).
• Ensures project team compliance with organization policies, SOPs, ICH- GCP, regulatory and project specific requirements.
Job Complexity
Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
Job Knowledge
Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways. Some barriers to entry exist at this level (e.g., dept. / peer review). Level at which career may plateau.
Supervision Received
Determines methods and procedures on new assignments and may coordinate activities of other personnel (i.e., Team Lead). Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
Business Relationships
Frequent contacts with internal personnel and outside customer representatives at various management levels concerning operations or scheduling of specific phases of projects or contracts. Creates formal networks with key contacts outside own area of expertise.
Qualifications:
Education and Experience:
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').
Knowledge, Skills and 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
Management Role:
No management responsibility
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.
Physical Requirements:
• Ability to work in an upright and /or stationary position for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Frequent mobility required.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Frequently interacts with others to obtain or relate information to diverse groups.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
• Regular and consistent attendance.
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