Job FunctionNIEUW: Project Director
Short DescriptionFor one of my clients I have a very interesting opportunity for a Project Director! This is a challenging role for which senior Clinical Project Managers or Project Directors can apply.
Function Profile•Accountable for managing, building and maintaining client relationships;
•Monitors project metrics, quality and performance, identifies opportunities for improvement and manages change initiatives effectively in collaboration with the team;
•Identifies and escalates risks and, in collaboration with key team members, develops and executes plans to mitigate risk;
•Writes a Project Management Plan;
•Ensures the quality as defined in the project plan, both internally with the project team and externally with the sponsor;
•Reports the progress made to the sponsor, the next level internally and the study’s Steering Committee (if applicable);
•Coordinates the activities of the project team and identifies capacity problems in respect of the individual and team workload;
•Provides prompt and clear information to all members of the project team and the sponsor with regard to study activities, upon which appropriate and quick decisions can be made with regard to the organisation and implementation of the trial;
•Manages the study costs in accordance with the sponsor contract and the budget;
•Works together with the legal advisors when site/investigator contracts, vendor and partner contracts have to be negotiated and executed;
•Stays abreast of latest developments in clinical study management, project management, drug development, and where possible, contributes to advances in the field;
•Contributing to Business Development, provides input to proposals and budgeting , performing Bid defences and maintaining a network (in relevant area);
Function Criteria•Academic level of education in biomedical sciences;
•A minimum of 8 years of progressive experience in life sciences, including 5 years of experience in a project management position in the biopharmaceutical industry; preferably CRO experience;
•Extensive experience with management of multinational/ international clinical trials; experience with oncology and/ or vaccine trials is an advantage;
•Extensive experience with the development of clinical protocols, policies and SOPs;
•Excellent knowledge of Good Clinical Practices and regulatory requirements;
•Proficiency in working with complex design issues (e.g., multiple arms, crossover, double blind, and multi-center) in all phases of pre-approval clinical trials;
•Proven leadership skills;
•Experience with budget planning and expenditure management.

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