15-02-2007 | EXPIRA LA 21-02-2007
Job expirat
- Working closely with clinical development and key opinion leaders you will conduct studies to support the life cycle of novel drugs post-launch;
- Conduct regional multi-center studies, ensuring start, end recruitment and study complete in-line with the international time frame.
- Project Management and Planning;
- Site Selection and Training;
- Clinical Monitor and Investigator Site Management;
- Protocol and CRF Development, Design, and Preparation;
- Conducting Investigator Meetings;
- Processing of Regulatory Documents;
- Quality Assurance and Auditing;
- Pharmacovigilance/Drug Safety;
- Development of Database Edit Check Manual;
- Review of Data Edits and Listings;
- In-house Second Review of Clinical Data;
- Query Generation and Resolution;
- Interim and Final Study Report Analysis;
- Biometrics and Statistical Analysis;
- Drug Safety and Pharmacovigilence;
- Safety Project Outsourcing;
- Experience in a reputed Pharmaceutical unit with hands down knowledge of Clinical Trails;
- Ability to create innovative solutions to achieve business goals;
- Experience in the management of clinical and / or medical affairs professionals and knowledge of several other key development disciplines (e.g. clinical research, health outcomes research, pharmaco-economics, regulatory affairs, and/or marketing);
- High integrity and strategic ability;
- Self-confident, proactive, highly interactive, and decisive leader who will facilitate the best possible execution of projects;
STUDIES:
- a degree in biological sciences or similar;
- previous regulatory affairs experience;
- a critical eye for detail;
- strong computer literacy skills;
- the ability to communicate effectively with both internal and external parties including government agencies.
SKILLS:
- Strong communication and interpersonal skills dealing with various cultures;
- Good communication style and reputation which inspires;
- Strong record of accomplishments and peer recognition in previous leadership positions;
- Excellent English skills.
Lider pe piata austriaca in domeniul recrutarii on-line, ISG Personnel Management furnizeaza SOLUTII COMPLETE in domeniul resurselor umane la standarde europene, recunoscute si verificate in peste 10 ani de experienta.
