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Clinical Study Manager

2 months ago


Canada Home Instead Woodland Hills Full time
Study Manager (SM) Job Description

Job Summary:

We are seeking a highly skilled Study Manager (SM) to join our Global Study Team. As a key member of the team, you will be responsible for delivering clinical studies to time, cost, and quality, ensuring inspection readiness, and driving continuous improvement initiatives.

Key Responsibilities:

  • Oversee study eTMF completeness, including setup, periodic reviews, and following up on missing documents.
  • Work closely with the Study Delivery Lead on end-to-end operational study delivery activities, from study setup to study archival.
  • Collaborate with internal and external partners on clinical study management activities, ensuring compliance with Study Team Operating Model (STOM), current clinical study regulations, and procedures.
  • Monitor study conduct and progress, identifying, resolving, and escalating risks/issues that may impact delivery.
  • Facilitate and maintain interactions with internal and external partners to ensure successful study delivery.
  • Manage vendor relationships, oversee study-specific deliverables, and ensure timely delivery of activities delegated to third parties.
  • Coordinate study-related activities, manage study team communication, and oversee delivery of clinical supplies and investigational products.
  • Ensure data oversight, ensuring the study is inspection ready at all times, and assure eTMF documents are complete and verified for quality.
  • Manage budget oversight, tracking updates, and escalating issues to the Study Delivery Lead.

Requirements:

  • University degree or equivalent in medical or biological science or a related field.
  • At least 3+ years of relevant work experience in a pharmaceutical/scientific environment.
  • Excellent knowledge of ICH-GCP, clinical study delivery process, and applicable clinical trial regulatory requirements.
  • Strong project management skills, leadership skills, and excellent communication and relationship-building skills.
  • Ability to manage multiple competing priorities, think independently, and analyze and solve problems systematically and creatively.

What We Offer:

  • Competitive compensation and benefits package.
  • Opportunities for professional growth and development.
  • Diverse and inclusive work environment.
  • Recognition and rewards for outstanding performance.

How to Apply:

If you are a motivated and experienced Study Manager looking for a new challenge, please submit your application, including your resume and a cover letter, to [insert contact information].