Oversee the management of several food clinical studies from set-up stage to study close-out in accordance with ICH-GCP, study protocols and applicable regulatory requirements.
Manage research teams throughout a trial ensuring appropriate training has been completed and quality standards are met.
Coordinate internal resources and third parties/vendors for multiple clinical trials.
Ensure all studies are delivered on-time, within scope and within budget.
Complete subject visits and data entry where necessary
Assist in the definition of project scope and objectives, involving all relevant stakeholders while ensuring technical feasibility.
Ensure resource availability and allocation.
Develop a detailed study plan to monitor and track progress.
Measure study performance using appropriate tools and techniques
Responsible for liaising with study Sponsor to give regular study updates and relay information to concerned parties.
Perform risk management to minimise project risks.
Establish and maintain relationships with third parties/vendors
Create, maintain and store study documents in accordance with ICH-GCP, study protocols and applicable regulatory requirements.
Meet with clients to take detailed ordering briefs and clarify specific requirements of clinical studies.
Delegate project tasks based on junior staff members’ individual strengths, skill sets and experience levels.
Track project performance, specifically to analyse the successful completion of short and long-term goals
Meet budgetary objectives and adjust project constraints based on financial analysis
Develop comprehensive project plans to be shared with clients as well as Atlantia staff members.
Use and continually develop leadership skills
Attend conferences and training as required to maintain proficiency.
Develop spreadsheets, diagrams and process maps to document needs, progress and reports as required.
2+ years experience in Clinical Trials or CRO setting
Proficient and experienced in Microsoft Excel, Word, PowerPoint and Outlook.
Excellent Computer skills and ability to pick up new electronic systems quickly.
Ability to prioritise tasks as appropriate to ensure deadlines are met.
Excellent organisational and time management skills. Attention to detail.
Excellent interpersonal skills and ability to handle sensitive information with the highest degree of integrity and confidentiality.
Professionalism and conscientiousness, comfortable with Client facing work.
Must be self-motivated with the ability to take initiative, work independently as well as supporting the team.
Ability to assist in developing new efficient and improved processes.
Flexible and willing to learn/grow with the company.
Positive 'can-do' attitude.
Internal Number: 001
About Atlantia Food Clinical Trials
Atlantia Food Clinical Trials is a world class company in delivering human clinical studies. We perform acute, observational and intervention studies to ICH-GCP standards for the functional foods, beverages, supplements, pre and probiotics and microbiome-based therapeutics sectors. We are committed to providing our expertise in clinical research to execute high quality trials. We are located along Chicago's Magnificant Mile. .