Senior Clinical Manager (m/f)

in Basel region  ‐ Onsite
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Keywords

Description

Hays ist ein weltweit führender Personaldienstleister, der sich auf die Rekrutierung von Spezialisten konzentriert - sowohl für den Projekteinsatz als auch für Festanstellungen und auf Zeit. In Deutschland, Österreich und der Schweiz vertrauen mehr als 600 internationale Topunternehmen auf unsere qualitätsgesicherten Prozesse, wenn Sie Experten suchen.


We are looking for a
Senior Clinical Manager (m/f)

Referenz: -en
Beginn: asap
Dauer: 6 MM
Ort: in Basel region
Branche: Sonstige Überlassung von Arbeitskräften

Ihre Aufgaben:
  • Support Clinical Trial Head in ensuring all trial deliverables are met according to timelines, budget, procedures and quality standards. This includes development of specific sections of protocol and related documents; development of study tools, guidelines and training materials; management of clinical study material, implementation of issue resolution plan; preparation of clinical outsourcing specifications
  • Responsible for management of CRO(s) and ensure adherence to scope of work within timelines and budget
  • Support the development, management and tracking of trial budget working closely with the TA program operations group
  • Support CTH in managing interactions within the global business
  • Accountable for accuracy of trial information in all trial databases and tracking systems.
  • Contribute to the ongoing scientific review of the clinical data and support trial data analysis, reporting and publishing
  • May participate in the organization and logistics of various trial related meetings with external customers
  • Point of contact for managing/answering questions related to trial procedures and patients' eligibility
  • Participate in clinical trial team meetings
  • Assist with program level activities (i.e., tracking of brand-related publications, development of clinical sections of regulatory documents like Investigators' Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions)
  • Responsible for implementation of best practices & standards for trial management within the TA, including sharing lessons learned


Ihre Qualifikation
  • Advanced degree or equivalent qualification in life science/healthcare required OR experience in clinical research OR Bachelors degree or equivalent qualification in life science/healthcare required if accompanied with a profound experience in clinical research
  • Fluent English (oral and written)
  • Involvement in cross-functional, multicultural and international clinical trial teams; demonstrated capabilities in supporting trial development, implementation and reporting activities
  • Good communication, organization and tracking skills
  • Proven networking skills and ability to share knowledge and experience amongst colleagues
  • Proven ability to work both independently or in a team setting, and to meet set goals by managing own timelines
  • Knowledge of GCP; basic knowledge of clinical trial design; understanding of the overall drug development process
  • Basic knowledge of principles for trial budgeting is preferable
  • Basic knowledge of Therapy Area preferable
  • Please send your CV by Tuesday January 17th 2012



Skills:
- Clinical Project Management
Start date
ASAP
Duration
6 MM
From
Hays AG
Published at
13.01.2012
Contact person:
Jennifer Knebes
Project ID:
297014
Contract type
Freelance
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