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Clinical Research Proposal Manager
Roles and Responsibilities
- Drawing up of proposal texts and cost calculations in view of the conduct of national and international clinical trials in various indications
- Organisation of feasibility requests
- Keeping of contacts/cultivation of relations to clients
- Proposal discussion
- Preparation and conduct of presentations
Requirements
- Professional experience as proposal manager, project manager or clinical research associate optimally in a CRO or in the field of the pharmaceutical/bioengineering industry
- Very good command of written and spoken English (business fluent)
- EDP experience (MS-Office, in particular MS Excel)
- Analytical thinking as well as number sense are prerequisites
Location
Business Development Manager
Roles and Responsibilities
- Maintain existing business
- Attain profitable net revenue growth in his markets
- Rejuvenate, build up new potential clients
- Presentations at clients
- Acquisition by telephone calls/mailing activities/advertising
- In charge of stands at congresses
- Development of strategies for expanding the market/opening up new markets
Requirements
- Study of medicine, veterinary medicine, or natural science (understanding of medical matters required) is a plus
- Practical experience in planning, conducting, supervising and evaluating clinical trials
- Experience in the field of business development; optimally, in a CRO or central laboratory
- Excellent knowledge of the pharmaceutical market,
- Preferably contacts with decision makers at pharmaceutical companies
- Very good command of written and spoken English (able to conduct negotiations)
- Excellent communication skills
Location
Medical Manager
Roles and Responsibilities
- Medical Project Management of multinational trials
- Medical review of study documents and clinical study data
- Pharmacovigilance within studies
Requirements
- Degree and license to practice medicine
- Extensive medical knowledge and very good knowledge of internal medicine and pharmacology
- Experience in conducting clinical studies
- Very good command of written and spoken English
- Experienced in MS office (Word and Excel)
- High motivation and team-oriented
- Good communication skills, dedication, reliability and a talent for organising are required
Location
Project Manager
Roles and Responsibilities
- Managing of clinical trials including
- Attainment of agreements with sponsor regarding execution of projects
- Planning of clinical trials as regards contents, regulatory compliance and administrative and logistic aspects
- Interface management
- Management and co-ordination of CRAs:
- Coordination of individual steps of national or multinational multicentre trials
- Supervision of GCP compliance (e.g. authorize study initiation)
- Supervision of the ongoing clinical part of a trial, as regards monitoring, safety aspects, timelines, and costs
- Supervision of study termination
- Prospective troubleshooting (e.g. communication of relevant issues turning up during the clinical part and respective decisions in a timely manner to all relevant parties)
- Transmission of information and discussion of the course of the project with the sponsor/DCO (Director Clinical Operations)
- Cooperation with data management, biometrician and medical writing, medical services and pharmacovigilance, quality assurance, training
- Participation in in-house inspections and/or audits (internal and external)
- Responding to audit/inspection reports
- Establishment of CAPA as applicable
Requirements
- Experience in clinical research (preferably in a CRO)
- A natural science degree or a pharmaceutical or medical degree is of advantage
- At least one year experience in planning, conducting, supervising and evaluating clinical trials
- The ability to think analytically and a talent for organising are required
- Ability to comprehend regulatory structures and procedures
- Ability to make oneself familiar with specific medical issues (e.g. study indications, symptoms, and methods for assessment of clinical parameters)
- Understanding of biometrical hypotheses/strategies
- Very good command of written and spoken English
- Excellent organisational skills and team leading skills
Location
Clinical Research Associate
Roles and Responsibilities
- To maintain awareness of local regulatory requirements, and to conduct studies in accordance with SOPs, guidelines and ICH Good Clinical Practice guidelines
- Recruitment of investigational sites
- Conducting as well as pre-/postprocessing of pre-study-, initiation-, monitoring- and close out- visits
- Creating study relevant documents
- Communication with investigational sites
- Participation in national/international project and investigational meetings
Requirements
- At least 1 year of established experience as a CRA
- Study of natural science (biology, chemistry), medicine, pharmacy or qualification as medical documentalist, health care specialist, paramedic professional
- Excellent command of native language
- Good command of written and spoken English
- Willingness to travel extensively
- The ability of a good communication, dedication, reliability and a talent for organising are required
- Excellent organisational skills and team leading skills
Location
- Bangalore
- Berlin
- Frankfurt
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