PROJECT DIRECTOR
By Mythu • Dec 19th, 2009 • Category: Biomedical Engineering, Biomedical Science, Medical Science
PROJECT DIRECTOR – France – Permanent Experience
* Minimum ten years experience in clinical biomedical research required * Minimum five years progressive employment-related experience in project scheduling, managing resources, and coordinating team activities required * Demonstrated experience with clinical development process, including clinical plan development, regulatory compliance, data management, and reporting through regulatory submissions, required.
* Thorough knowledge of regulatory requirements and ICH-GCP required * Prior project profit and loss management responsibility required; experience working with budgets, identifying out-of-scope project work and assessing in a timely manner the need for change order * Minimum of two years of experience managing professional staff or comparable project management experience required * Minimum of four years experience using computerized information systems required; experience with PC-Windows and word processing preferred
* Read, write, and speak fluent English; in Europe, fluency in the language of the host country is also required Education * An undergraduate degree in health sciences from an accredited institution or equivalent degree plus required experience
* An advanced degree (M.S., Ph.D., Pharm.D., M.D.) preferred * Targeted coursework in business issues (management, marketing, accounting), budgets, personnel management, negotiation skills, etc. required; Masters of Business Administration from an accredited institution or related coursework with employment experience is preferred Essential Functions
* As a member of the region’s management team, schedules and supervises clinical projects, provides leadership in the delivery of services to clients; reviews work produced by the project team; ensures staff fulfill their responsibilities in accordance with project contract and in-house policies, procedures and Standard Operating Procedures (SOPs) * As key participant in the team selling process, shares responsibility for growing business with existing clients and for identifying and closing projects with new clients; participates in presentations to the client and provides input to the project bid process
* Takes lead role in day-to-day management of strategic projects such as clinical development programs and major domestic or international studies, and ensures that projects are delivered on time, within budget and according to client expectations * Provides significant input into pre-clinical data assessments, IND preparation, regulatory approval strategies, development program plans, clinical protocols, project plans and investigator brochures * As a senior member of the professional staff, keeps up with current industry practices and regulatory requirements; participates in the design and implementation of high-value solutions for clients on a billable basis; and provides leadership in the definition and delivery of well-managed clinical research projects
* Ensures all internal and external issues regarding clinical research projects are properly addressed * As an experienced member of the client’s professional staff, is an active mentor to one or more junior staff members and provides formal classroom as well as in-service training as requested by his/her functional leader * If assigned direct reports, schedules and reviews project tasks; provides leadership in the delivery of services to clients; ensures that staff fulfill their responsibilities in accordance with the client’s policies, procedures, and SOPs; and ensures HR processes are properly implemented
Responsibilities and Additional Duties To clients and prospective clients: * Takes a lead role in interfacing with clients and prospective client organizations, providing both technical and business credibility; is responsive to the client while assuring comprehensive management of quality clinical research projects * Maintains active, personalized, professional relationships with key client accounts through regular contact and value added consultation; monitors client satisfaction with project * For all assigned projects, works with client to develop a thorough and unambiguous understanding of tasks, project scope, and schedules
To Project Teams: * Ensures each team is staffed with qualified personnel; complies with all contract provisions, ICH-GCPs, and regulatory requirements related to the project * Ultimately assures all project administration, study documentation, and reporting requirements are met in a timely manner * Participates in the development, review, and critique of key documents such as protocols, CRFs, analysis plans, reports, and regulatory submissions, and ensures review of same by appropriate team member(s)
To the Regional Director and Business Management Team: * Is responsible for recommending, implementing, and achieving assigned objectives and budgets for all assigned project teams * In coordination with each functional leader for project team members, is responsible for the efficient and effective planning, implementation, and monitoring of project status to ensure optimal utilization of billable staff To Project Management team: * Passes on information to keep other project team leaders apprised of current events and status of managed projects, client relationships, communication with functional groups, and project teams within region
* Provides clear team and individual goals and expectations and ensures that each member of the project management staff understands her/his responsibility to know and follow all SOPs and corporate policies
To Other Regions: * Participates in the review and update of project management SOPs and the client’s business processes; ensures operational consistency with defined company-wide practices
Only successful applications will be responded.
Tags: Biomedical Science, France, Project DirectorRelated posts
Mythu is a postgraduate in Bioinformatics. Currently working as Content Developer for Bioscience Subjects in Chennai. Her hobbies are singing, playing piano, collecting interesting idols, love towards music and Sci-Fi magazines.
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