Your challenge Reporting to the Medical Director, the Clinical Study Manager is responsible for the independent implementation and management of clinical studies within defined business requirements of cost, quality & time, in accordance with applicable regulations & company policies & procedures.? The position has a threefold dimension, covering management of studies, compliance with applicable regulations and laws, and management of Clinical Research Organizations (CROs) or contractors surrounding the management of investigational sites.
Your responsibilities The Clinical Study Manager is responsible for the management of clinical studies from trial plan to final report, ensuring that the clinical trial is : · designed and carried out ethically; · using sound scientific principles; · adherent to clinical trial regulations and company policies & procedures (FDA, EU, GCP guidelines); · providing high-quality data; · meeting study objectives; · providing expected outcomes.
More specifically he or she is accountable for : · Establishing the Clinical Trial Management Team and managing clinical trial budget · Negotiation, contracting, and timely and cost-effectively managing CROs or contractors · Identifying the local and regional regulations and laws which apply to clinical trials · Selecting qualified investigator(s) and sites · Creation of the documents necessary to support the clinical trial such as : * written procedures for the design, conduct, monitoring and auditing of the clinical trial; * clinical site agreement; * clinical plan; * investigator's brochure; * monitoring plan; * informed consent form (ICF) for subjects; * case report forms (CRFs) to collect data · Obtaining institutional and regulatory approvals as required · Ensuring that the rights, safety, well-being and privacy of subjects are maintained · Ensuring implementation of Adverse Event reporting and adequate follow-up · Implementation of the Clinical Plan · Identifying possible problems/risks, create mitigation plans and take corrective actions · Verifying that data is generated, documented and reported with integrity and in compliance with regional and international standards and regulatory requirements · Generation of the study report and expected outcome with a sound scientific quality and compliant with regulatory requirements
Company background Philips Handheld Diagnostics (HHDx) venture has developed the Minicare system, an easy-to-use handheld point-of-care testing platform which aims to bring lab equivalent performance at the patient bedside. The HHDx venture operates in the Point of Care market space, which can be defined as the place where blood testing is taking place close to the patient. The Point of Care market is around $5.4 billion and growing at 6%. Cardiac point of care is a significant segment at around $680 million and growing at 9%.The first focus of the venture is to launch two important Cardiac Markers (cardiac Troponin-I and BNP) on the Minicare system. Product, production processes and organization are built from scratch. Aim is to generate new business in a new market which will significantly contribute to the growth ambitions of Philips.x
Our offer We welcome you to a challenging, innovative environment with great opportunities for you to explore. Our benefits are very competitive and designed around your preferences: · Depending on experience, a year salary (fulltime) between €64000,-and €82000,- (including personal benefits package) · 25 Days of leave and the possibility to purchase up to 20 extra days off annually · A variable bonus based on both Philips results and personal performance · Extensive set of tools to drive your career, such as a personal development budget, free training and coaching · Solid company pension scheme and attractive collective health insurance package · Opportunity to buy Philips shares and products with discount · Healthy work-life balance
We are looking for · M.D., Ph.D. or M.S. in Biology, Pharmacy or closely scientific related discipline. Equivalent education or experience will be considere · At least 3 years’ experience with clinical trials for In-Vitro Diagnostic Medical Devices in industry or a Clinical Research Organization is desired. Experience with global studies is strongly preferred · Proven working knowledge of GCP guidelines, FDA regulations as well as EU regulations for IVD devices · Biostatistics knowledge and proficient computer skills across multiple applications and experience with Data Management are recommended · Experience in developing trial plans including protocols, site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management is desired · Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology is recommended · Excellent oral and written communication skills (English) are necessary · Experience with working in an international environment is recommended · Medical background and international network in cardiology and emergency medicine is a plus. · Auditing experience is preferred Key personal characteristics · High scientific rigor in thinking process with a high commitment in ethics and quality · High agility in strategic thinking with high level of pragmatism · High business acumen, and driven by results · Used to work in a complex and highly dynamic environment across matrix organization · Proactive attitude · Strong organizational ability · Team leadership and ability to collaborate effectively with the Clinical Operations study team, R&D team, cross-functional team members, and external partners · Ability to set priorities, work independently without direct supervision as well as in a team environment · Conscientious and precise delivery of work even when under pressure · Open and clear communicator with good communication skills · Systematically perform activities in a timely and accurate manner · Work precisely according to procedures, rules and regulations and able to keep oversight on processes
Recruitment process If you’re interested in this opportunity to join us, please upload your resume and motivation letter through the Philips career site- vacancy number 059775. Please note that the closing date of this vacancy is 16-02-2014.
ADO Price at posting:
17.0¢ Sentiment: LT Buy Disclosure: Held
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