Clinical Development Manager

GenevaFixeChimie, Pharma, Biotechnologie2019-07-10Non exigé / Non qualifié
Spring Life Sciences is looking for his client a

Clinical Development Manager

The Role:

• Contributes, with appropriate oversight, to all aspects of the assigned clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance and performance standards.
• May lead specific aspects of the assigned clinical trial(s).
• Core member of the Clinical Trial Team (CTT), deputy for the Associate Clinical Development Director/Clinical Development Director. Contributes to operational excellence through process improvement and knowledge sharing.

Responsibilities:

1. Contribute to all operational trial deliverables, under the oversight of the Associate Clinical Development Director/Clinical Development Director, according to timelines, budget, operational procedures, quality/compliance and performance standards.

2. Resource Management:
• Support the Associate Clinical Development Director/Clinical Development Director with the development, management and tracking of the trial level life cycle budget including forecast, and annual cost targets.

3. Core member of the CTT; participate in establishment of study progress and issues/resolution plan at the CTT meeting; can deputize for the Associate Clinical Development Director/Clinical Development Director to chair and facilitate CTT meetings. Ensure completion of CTT meeting minutes. Organize and chair trial sub teams within the scope of his/her delegated responsibilities.

4. Contribute to preparation of the Data Review Plan (DRP); participate in data review as specified in the DRP.

5. Contribute to the development of clinical sections of regulatory documents e.g., Investigators' Brochures, Annual Safety Update Reports.

6. Contribute to talent development through active participation in onboarding and training activities. May participate in Development Operations and/or cross-functional initiatives.

7. Responsible for education, implementation and compliance to standards (SOPs) and best practices for trial management within assigned clinical trial(s), including sharing lessons learned.

Profile:

• Advanced degree or equivalent education/degree in life science/healthcare recommended.
• Fluent English (oral and written).
• 3-5 years of experience in a pharmaceutical company or a contract research organization with a minimum of 2 years in global clinical research. Involvement in cross-functional, multicultural and international clinical trials demonstrated ability in supporting operational aspects of clinical trials.
• Excellent communication, organization and tracking skills. Strong operational skills and demonstrated ability to meet timelines.
• Proven ability to work either independently or in a team setting, to meet goals by managing compliance and budget.

Votre contact

Etes-vous intéressé(e)? Merci de postuler directement en ligne.

Merci de préciser la référence JN -072019-296715 - HAID.

Postuler