• Project Management: Facilitating communication and collaboration across departments, Maintaining excellent quality standards for continued compliance, Building positive, productive relationships with internal and external contacts through outstanding client management skills, Conducting technical and customer meetings, increasing communication and strengthening sponsor relationships, Leading meetings with department executives to review project status, drafting action plans to deliver proposed changes, Delivering exceptional service to clients, maintaining and extending working relationships for future business opportunities, Designing project presentations and reports for executive teams, Problem Solving, Proactive Monitoring
• Planning: Defining project scope, guidelines, milestones and task allocation to establish and maintain clear progress plans, Generating project cost estimations with outstanding accuracy, guiding effective decision-making, Collaborating with cross-functional teams to draft strategic, realistic project schedules and plans, Coordinating supply chain and procurement processes to meet budget needs, Recruiting and onboarding required contractors and subcontractors for maximised project efficiency.
• Budget and Contract: Planning Budgeting & Forecasting, Budget Process, Contract Negotiation, Tracking expenses and business outgoings to remain within cash flow targets, Reviewing and negotiating various contracts, master agreements and vendor contracts in cooperation with the legal department, Reducing costs by allocating site resources and subcontractors for strict budget controls.
• Leadership: Monitoring communication flow, Briefing and motivating the team to deliver periodical operational requirements, Recruiting high-performing, reliable staff for improved team productivity, Coaching & Mentoring, and Achieving project deadlines through focused staff and resource planning.
• Reporting: Client Follow-Up, Team follow-Up, Maintaining and managing Trackers according to the sponsor's needs, Tracking and reporting project status, timelines, budgets and action items from project inception to delivery.

• Improving operations by generating project status reports and identifying issues for corrective action.
• Briefing and motivating site teams to deliver quality results.
• Sourcing cost-effective materials and equipment, keeping projects within budget.
• Ensuring that clinical research activities and research activities are conducted in compliance with local regulations by maintaining coordination with Buildings/Facilitating and Investigators/Sites.
• Monitoring the site and sponsoring agency policies and procedures on a timely and remote basis.
• Coordinating the consistent, high-quality provision of clinical research services.
• Recruiting committed, hardworking clinical teams for reliable care services.
• Setting and monitoring performance targets for optimised service-user care.

Through the efficient combination of expertise and quality, MIRA Projects has consistently assured the compliance of Clinical Trials with ICH/GCP, international, and local regulations.

• Training all team members, and monitoring successes and failures to identify areas of improvement.
• Oversaw all quality-related issues, driving problem-solving techniques and corrective actions to maintain high levels of customer satisfaction.
• Optimising workplace procedures for safety, developing and updating processes based on the latest research.
• Visiting site locations for planned assessments and investigations of reported violations for quality purposes.
• Analysing written reports and statements to verify regulatory compliance.

Knowledge is power in the face of healthcare complexity. The learning tools provided by MIRA Projects Ltd can be used to improve performance and compliance.

• Organising delivery of specialised training in liaison with external service providers.
• Engaging professionals in industry-specific knowledge, techniques and methodologies.
• Formulating training and development programmes to capture measurable improvements.
• Planning training schedules, preparing materials and booking necessary rooms and facilities.
• Implementing research findings and client feedback to improve programme material and delivery.
• Producing training and support materials tailored to organisational needs.
• Facilitating high-quality workshops, meetings and demonstrations online and offline.
• Providing a variety of training programs available for investigators, coordinators, CRAs, managers, and more.
• Outlined HR objectives and assessed learning outcomes to guide planning activities.
• Specialised training courses and workshops include, but are not limited to; CRA Workshops, Management Workshops, Investigator Training, Trial Specific Training Courses, Tailor-made training courses on clinical research, Training courses on ICH GCP guidelines and local legislation, Principles and Regulations of Clinical Research, Informed Consent Process, Clinical Trial Monitoring, Budgeting and Contracting.

Regulatory Affairs for pharmaceutical products is a complex process. Every country has its specific requirements related to medicinal products. As regulators get tougher on enforcement, a proactive approach to quality and regulatory compliance can ensure sustainable success. As MIRA projects we provide the following services:

• Developing policies and systems to ensure clinical studies successfully achieve objectives.
• Ensuring company policies were implemented and adhered to.
• Created ethical standards and procedures to improve current company guidelines.
• Finding regulatory breaches and providing firms with constructive guidance.
• Explaining technical regulations to non-technical customers in a clear and concise manner.
• Distributing information leaflets on regulatory compliance to business owners.
• Writing or updating standard operating procedures, work instructions or policies.
• Following up regulations periodically.
• Predicting future developments so that your company/sponsor can plan clinical activities more effectively.
• Providing comprehensive solutions based on local regulations and experiences.
• Registering with the Ministry of Health of Turkey to complete the submission as the legal representatives.

With the help of our solution partners, we can provide Clinical Trial Assistants, Clinical Research Associates, Study Nurses, Study Coordinators, and other relevant personnel within the realm of clinical trials.

• Developing a solid understanding of client companies' values, work culture and environment.
• Drafting and publishing vacancies on relevant job search platforms.
• Storing and processing job applications, and providing selected candidate information to recruiters.
• Registering new candidates, and developing a wide-ranging database to meet client recruitment needs.
• Completing new staff onboarding documentation and reference checks.
• Communicating interview outcomes with internal and external candidates.
• Documenting performance review outcomes to aid continued personnel development.
• Calculating and recording monthly staff salaries and contractor payments.
• Mentoring employees to develop competent staff.
• Updating records with employee status, personal information and agreement term changes.
• Maintaining clear, accurate salary records for improved department budgeting.
• Checking payroll matched assigned budgets, reporting discrepancies.