MariaK is a consultancy providing services in clinical research and clinical trials management
About
MariaK has many years of experience from pharmaceutical companies and CRO (Contract Research Organisation) in managing national and international Phase I to Phase IV clinical trials, all the way from the study start to the final clinical study report; including study outline, planning, coordination, management, performance,
termination and reporting of the trials.
She also has experience in Clinical Project Leading in clinical trials having an overall administrative responsibility to supervise, co-ordinate and lead study specific activities and to implement and conduct a clinical study in accordance with the Company SOP´s, ICH-GCP requirements and local regulations.
Apart from that, MariaK has experience in Clinical Trial Management for Phase I and Phase II studies and offers pre-study services such as study protocol writing, CRF design, Data Management duties, study report writing and coordination and management of study team, setting up study documentation, also including SOP:s, and budget responsibility for clinical trials and consultants.
Experience in following therapeutic areas:
MariaK offer clinical development services for pharmaceuticals in phase I-IV and have experience as consultant for different pharmaceutical companies in the conduct of multi-centre clinical research studies with experience in following therapeutic areas:
Project Management
Experience
• Management of projects of full scope both regional and global projects to assure operational processes are maintained and that projects are done within scope.
• Negotiation with clients and been the point of contact for assigned protocols within CMC, Clinic, Reg and pre clinic and pro-actively drive/track execution and performance of deliverables / timelines / results to meet study commitments and to align on key decisions in countries.
• Been accountable for the performance for assigned protocols in countries worldwide, in compliance with ICH/GCP, country regulations, policies and procedures and quality standards.
• Management study and overalls program budgets, contracts and proposals with final project contract execution and documentation by the project team.
• Been responsible for quality and compliance for assigned protocols and overseen CRAs and CTMs with training compliance.
• Performed quality control visits, reviewed Monitoring Visit Reports and escalates performance issued training needs to functional vendors and internal management.
• Assisting/supporting the development, documentation, and updating internal processes and processes required for consistency across programs such as SOPs, working practices, and related quality assurance forms.
• Building and maintaining positive client relationships.
• Responsible for collaboration and relationship management with investigators and other external partners.
• Assisting/supporting local and regional strategy development plans in conjunction with pre clinic and clinical operations.
• Knowledge of EMA/FDA, local regulations, and GCP and ICH Guidelines for clinical research.
• Skills to coordinate and align with the regional and broader organization.
• Ability to identify problems, conflicts and opportunities early and lead, analyze and prepare mitigation plans and drive conflict resolution in tough situations with both internal and external groups.
Services
MariaK provides the following services of clinical trials (phase I-IV):
C lients
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