CRA MANAGERDeze vacature staat offline! | ||
| De Opdrachtgever | ||
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Toonaangevende farmaceut in Noord-Holland. | ||
| Functieomschrijving | ||
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MISSION OF DEPARTMENT To provide local site and study management and central coordination of the monitoring function from feasibility to study completion, across all regions, phases and therapy areas. PURPOSE OF THE ROLE Manage the Clinical Monitoring organisation in a country, or group of countries, to ensure that trials are conducted with concern for ethics and patient safety and in compliance with Good Clinical Practice and local regulations. Serve as local expert for site and study management Plan and manage the operational performance of the Clinical Monitoring organisation in the country to ensure that appropriate targets for time, cost and quality are set and managed. Key tasks and responsibilities. 1. To recruit, train, develop and motivate staff. 2. To set goals and objectives in line with department and study goals 3. To manage individual performance including performance appraisal and salary review. 4. To forecast, plan and manage the resources needed for trials run in the country, maintaining sufficient flexibility to respond to changing priorities 5. To manage contract staff and to oversee the performance of CROs when monitoring is outsourced 6. To manage the performance of Clinical Monitoring staff (including in-sourced staff) in the country and to ensure that time, cost and quality objectives are met. 7. To ensure that all operations are undertaken in compliance with the appropriate regulations, guidelines, policies and SOPs. 8. To serve as the local expert for site and study management in the country, providing input to feasibility, site selection, recruitment plans, local ethics and regulatory submissions 9. To provide solutions to local problems in trial management through local knowledge and relationships 10. To build and maintain strong relationships with commercial management and ensure full collaboration on clinical trial activities performed in the country 11. To initiate, maintain or support the continuous improvement and implementation of processes and technologies in study monitoring and data acquisition. 12. To promote the consistency and harmonisation of processes and deliverables across trials and locations. PROFILE EDUCATION/LANGUAGES • Degree or higher qualification in biological science subject or equivalent • Excellent oral and written communication skills in English. • Fluent in local language PROFESSIONAL SKILLS & EXPERIENCE • At least 8 years experience as a monitor in biotech, pharmaceuticals or CRO • Experience in different phases of clinical development and in different therapy areas. • Excellent knowledge of GCP and applicable local regulations. • Experience of in-sourcing and/or outsourcing • Proficient PC skills: Word, Excel, and PowerPoint, e-mail. Profile PERSONAL SKILLS & COMPETENCIES • Strong interpersonal skills • Good people management and coaching skills. • Excellent organisational ability and flexibility. • Highly self-motivated and proactive. • Ability to assess risk, solve problems and take decisions. • Good team player. • Willing and able to travel. | ||
| Contactinformatie | ||
Heb je interesse in deze vacature, meld je direct aan middels de button 'aanmelden' of neem contact op met:
Geïnteresseerden kunnen hun c.v. ook rechtstreeks mailen naar andrea@pharmamediair.nl. |
