Global Studies/Study Manager (GSM ) PHARMA / ro-323

Status: 
closed
Location: 
4070 Basel
Start Date: 
2018-05-14
End Date: 
2019-04-02
Deadline: 
2018-05-09 15:00
Hours per day: 
8,00
Hours per week: 
40,00
Workload: 
100%
Total Hours: 
4.176
Assignment: 

Background

For our Swiss customer located in Basel we are currently looking for (m/f) a Global Studies/Study Manager (GSM ) PHARMA

  • Type of placement:   12 months, external contract with possible long term extension
  • Company:  major Pharma company in Basel area
  • Salary:  level 2-3, please ask us for the exact rate range 

(monthly gross salary levels in CHF,  level1= 5-10k , level2=10-15k,  level3= >15k) -PHARMA

 

The positions are open in the Oncology Team

Duration: 1 year

Start day: asap
 

 

Position Purpose

  • Provides the operational expertise and leadership to one or more cross-functional global Study Management Teams (SMTs)
  • Ensures the timely and efficient delivery of all operational aspects of one or more studies through all phases (phase 1b-IV) and stages (start-up, conduct and close-down), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations.

 

Main Responsibilities and Accountabilities

  • Provides direction and leadership to one or more global Study Management Teams (SMTs)
  • Contributes to the development and management of the study timelines, budget, risk and quality plans
  • Provides clinical operations expertise to ensure operational feasibility and delivery
  • Oversees forecasting of clinical/non-clinical supplies
  • Delivers the operational elements of the study plan
  • Provides the day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work
  • Identifies areas of best practice and process improvements
  • Ensures study adherence to ICH/GCP and SOPs
Requirements: 

Qualifications

  • Life sciences degree or nursing equivalent.

 

Experience

  • Proven clinical development experience of the operational aspects of all stages of clinical studies preferably working in a Global environment and/or including monitoring or leading affiliate teams, working with vendors and/or CROs, drug supply management and planning operational activities to achieve database lock.
  • Experience of project managing operational aspects of a clinical study including development of timelines and budgets.
  • Good knowledge of ICH GCP
  • Proven ability to successfully achieve results within a multi-cultural and geographically diverse team.
  • Experience of working as part of a large team and leading small study or functional teams, with a proven ability to be an active member of the team and motivate and lead a small team to deliver against commitments.
  • Well developed written and verbal communication skills demonstrated by an ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization.
  • Strong attention to detail
  • Proficient computer skills

Competencies

  • Technical and Business ExpertiseTeamwork and Collaboration
  • Communication
  • nAchieving Results

Other

  • Mobile: Some travel may be required