JOB SUMMARY

The Senior Project Specialist is responsible for maintaining and coordinating the logistical aspects of clinical projects, and provides overall support to functional leads to ensure the successful completion of project deliverables

The Senior Project Specialists supports the Project Lead (PL) to ensure the contracted services and expectations of assigned projects are carried out by the project teams in accordance with executed contracts and the customers' requirements. Operate independently, with minimal day to day oversight, and may co-ordinate the activities of Project Specialists

JOB RESPONSIBILITIES

• Set-up, maintain and close out project files and study information ( (e.g., KPIs, regulatory documents, Trial Master File (TMF), enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), protocol deviations, site supplies, Institutional Review Board re-approvals, data queries) on a variety of databases and systems.
• Maintain and distribute study-specific /financial reports (e.g. vendor/site invoices, investigator payments (grants and pass-through), forecasts, etc) .
• May lead internal and external meetings as directed by the PL Prepares and distributes meeting minutes and action items for both internal and external meetings (sponsor, trusted process, functional, investigator meetings). Follows up with team members on action items to closure.
• Records the status of Key Performance Indicators (KPIs) in assigned systems, with input and oversight from the assigned PL. Assesses and communicates KPIs for associated job tasks to PL with proposed action plan. Prepares and provides status reports to customers with oversight from assigned PL
• Ensure all study documents are archived based on the appropriate guidelines and policy.
• May serve as project representative for internal and external audits. Provide support for quality assurance activities, including preparation for audits and internal review, preparing documentation and follow through to resolution actionable issues.
• May serve as primary customer contact when PL is out of the office. Seeks input from Project Director for customer support.
• May mentor and train Project SpecialistsQUALIFICATION REQUIREMENTS

• Bachelor's Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field or equivalent combination of education and experience

• Moderate relevant clinical research experience with an understanding of clinical drug development and clinical trial operations. Experience in a therapeutic group preferred.

• Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements

• Strong organizational skills.

• Ability to perform several tasks simultaneously to meet deadlines. Self-motivation and ability to work independently. .

• High proficiency with full MS Office Applications

• 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%)

• High level of competence in English language

Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.