Associate Director, Start-up Lead, SiteID & Activation

The businesses of Merck KGaA, Darmstadt, Germany•Billerica, MA

36d•$128,700 - $193,000

About The Position

We are seeking an experienced clinical research professional to serve as the Associate Director, Start-up Lead, SiteID & Activation to lead start-up and site activation strategies across our global clinical trial portfolio. This role is crucial in driving operational excellence to bring medicines to patients faster and ensuring compliance with ICH-GCP standards and applicable regulations.

Requirements

Medical or Life Sciences degree or equivalent qualification
10+ years in clinical research in a CRO or Pharmaceutical / Biotechnology Industry environment
5 years of project management and experience in study start-up activities
Thorough knowledge of ICH-GCP and applicable laws and regulations for key countries

Nice To Haves

PM certification (CPM, PMP)
Strong communication skills - verbal, written and listening
Fail fast and data driven mentality as well as agile methodology
Strong data insights and analytical skills to identify trends and drive quality / process improvements
Ability to balance competing priorities of various stakeholders and strive for achieving mutually beneficial and compliant solutions
Experience in multiple Therapeutic Areas, especially in oncology

Responsibilities

Oversee country and site feasibility assessments
Drive regulatory submissions and site activations from protocol through implementation
Collaborate with internal teams and external service providers to accelerate study timelines and optimize recruitment outcomes
Champion process improvements
Manage performance metrics
Drive operational excellence to bring medicines to patients faster
Ensure compliance with ICH-GCP standards and applicable regulations