Associate Director, Clinical Operations Process Excellence job in Boston, USA | ��ý��ygfcmw��(�й�)վ��ֱ�ӽ�

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Job type: Contract

Discipline: Project/Study Manager (CSM/CPM), VP/Head of Clinical Operations

Location: United States

This vacancy has now expired. Please see similar roles below...

Associate Director, Clinical Operations Process Excellence - Contract - Boston, MA

��ý��ygfcmw��(�й�)վ��ֱ�ӽ� is seeking a Clinical Operations Process Excellence Specialist to join our team. In this role, you will focus on developing and implementing global standards and processes to enhance consistency within the Clinical Operations organization. You will collaborate across functions to support clinical study management tools and contribute to continuous improvement initiatives. This position is pivotal in driving operational excellence and ensuring inspection readiness.

The Clinical Operations Process Excellence Associate Director will:

Develop and create governance, processes, and guidance documents for Clinical Operations and Clinical Trial Teams.
Assist in the development and implementation of study-related tools, guidelines, and training.
Manage onboarding and offboarding tools for clinical operations.
Lead quarterly Key Performance Indicator (KPI) updates and ensure accurate information distribution.
Oversee the Clinical Operations Tool Kit and manage document reviews.
Support audit processes and act as a central contact for the Quality team.
Serve as a subject matter expert for initiatives with Clinical Operations Leadership.
Independently manage projects and report on outcomes.
Conduct post-study assessments to identify improvements.
Track progress on department initiatives and report to leadership.
Review standard procedures and collaborate with subject matter experts.
Lead risk management activities and assist with organizational training.

Skills & Requirements:

Bachelor's degree required.
Experience in clinical research within the pharmaceutical industry.
Proficiency in clinical trial processes and project management.
Strong leadership, collaboration, and change management skills.
Knowledge of GCP, US FDA regulations, and global regulatory requirements.
Ability to work autonomously and solve problems effectively.
Experience in multiple therapeutic areas, including oncology and rare diseases.
Excellent interpersonal, organizational, and communication skills.
Creative problem solver with a customer service mindset.

If you are having difficulty in applying or if you have any questions, please contact Bo Forsen at b.forsen@proclinical.com

��ý��ygfcmw��(�й�)վ��ֱ�ӽ� is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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��ý��ygfcmw��(�й�)վ��ֱ�ӽ� Staffing is an equal opportunity employer.

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