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Associate Director – Clinical Operations 5255

 

Our client, a dynamic biopharmaceutical company located in North Switzerland and focused on developing and commercializing small-molecule medicines for the treatment of cancers and immune-mediated diseases, is looking for a Study Management Associate Manager

to start as soon as possible for a permanent role.

 

The Associate Director – Clinical Operations  is responsible for managing a cohesive team of front-line study execution staff to deliver best-in-class study execution.

 

The ideal candidate should have at least 8 years of experience at senior level, 6 years of relevant study operations management and people management experience (team of about 15).

 

Main Responsibilities:

 

  • Delivering on best-in-class study execution, driving financial/headcount efficiencies, and increasing flexibility to rapidly respond to shifting business needs
  • Partnering with study teams to drive the implementation of the aggressive execution strategies in challenging spaces such as Enterprise Critical programs, filings, etc.
  • Resourcing, development of high performing teams, contracting, budgeting, hiring, performance reviews, and leading talent development of staff, elevating team to think more strategically, creating a culture of challenging the status quo to drive efficiencies and innovation
  • Utilizing deep understanding of study execution to support front-line staff and strength in influencing/partnering to build trust with CDO and cross-functional stakeholders.
  • Coaching and mentoring junior and peer SMA Managers, as well as advise those mangers on actual challenges they’re facing. Establish and conduct managerial learning forums junior and peer SMA Managers
  • Developing SMA IIIs to be strong peer coaches, through individual coaching and through establishment and conduct of coaching learning forums.
  • Analyzing internal and external market intelligence to identify and drive process improvement and innovation.
  • Designing and create training curriculum as well as lead development of SOPs, job aids, tools, templates, and work instructions in partnership with CSL leadership that drives consistency, alignment, and efficiencies across multiple Therapeutic Area study execution.
  • Contributing to study execution intelligence gathering across multiple countries and TAs. Analyze performance metrics and KPIs to identify trends/risks and develop mitigations.
  • Ensuring compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines.
  • Leading cross functional initiatives and initiatives within the Study Management organization.

 

Qualifications and Experience:

 

  • Minimum of Bachelor's Degree in health care or scientific field
  • Minimum of 8 years of clinical research experience, with 6+ years of relevant study operations management and people management experience.
  • Proven leadership skills in a cross-functional global team environment, experience in managing remote/virtual teams, and an ability to influence and align stakeholders, while modeling and driving the companies leadership attributes
  • Strong analytical and critical thinking skills and the ability to evaluate complex issues from multiple perspectives and drive smart decision making.
  • Expertise in drug development, operations, risk management, successful decision-making, strategic execution, and resource/budget planning across global geographies and therapeutic areas, in a fast-paced environment
  • Demonstration of successful study execution and aptitude for managing multiple priorities in a fast‐paced environment.
  • Advanced working knowledge of ICH and GCP guidelines and operational understanding of the global regulatory environment
  • Considered a subject matter expert in the application of Standard Business Procedures (International Conference on Harmonization, Global Regulations, Ethics and Compliance).

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