Job Summary
The Sr. Project Associate will drive and support project management activities to ensure successful execution of complex clinical trials, which may range from single service studies to full scope or multiple protocol and/or global projects with minimal oversight. This role requires thorough execution of project tasks, maintaining documentation, communicating with stakeholders, and maintenance of timelines and budgets. The Sr Project Associate allocation will vary in size and complexity including the possibility of overseeing junior team members.
Work schedule: 3rd Shift (8:00 PM to 5:00 AM Indian Standard Time).
Responsibilities
- Drives the planning and execution of elements of clinical trials in partnership with the Project Lead.
- Ensures projects adhere to strict timelines and are delivered within budget.
- Serves as subject matter expert of relevant project management tools and systems.
- Coordinates internal resources and third parties/vendors for the efficient execution of projects.
- Maintains and distributes study-specific financial reports and contributes to study s financial health using financial processes and systems.
- Conducts ongoing analysis of project performance to drive the successful completion of short and long-term goals.
- Documents project scope and objectives, involving all relevant stakeholders.
- Leads communication between project team members, ensuring all parties are informed of project status and changes.
- Documents and escalates project risks and issues and drives timely follow-through and completion.
- Maintenance of systems and project management tools and methodologies.
- Drives quality assurance activities, including preparation for audits and internal review, prepare documentation and follow through to resolution on actionable issues.
- Oversees tasks and activities by providing mentorship and coordinating junior team members, while operating independently with minimal oversight.
Qualifications
- Bachelor s degree (or equivalent) level of qualification in life sciences, medicine, pharmacy, nursing, project management or related field or equivalent combination of education, training and experience.
- Must have 2-4 years of clinical experience, currently performing the responsibilities of Project Associate/Specialist, etc.
- Must have knowledge experience with Clinical Trial Systems , CTMS, TMF, PDC (Project Delivery Center), SOPNet, etc.
- Knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.
- Strong organizational skills.
- Ability to manage time and work independently.
- High proficiency with full MS Office Applications and/or project management software tools.
- Strong communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
- Ability to travel if necessary preferred (approximately 5%).
- Effective verbal and writing skills in English.