Senior Clinical Site Manager

Sweden
09-07-2024
Job Type
Permanent
Emp Type
Full Time
Functional Expertise
Clinical Operations
Salary Type
Annual

Job Description

Clinical Trial Research Specialist - South Sweden

Summary

This role is responsible for ensuring the smooth execution of clinical trials by maximizing research partner performance and engagement. The research specialist will leverage their expertise in the therapeutic area to provide support throughout the clinical trial process. They will also be responsible for planning, initiating, coordinating, and managing all monitoring activities to ensure compliance with regulations and standards. This role requires collaboration with internal and external stakeholders, including investigators, sites, and vendors.

Key Responsibilities

  • Develops and implements strategies to build strong relationships with research partners throughout the trial lifecycle.
  • Identifies and qualifies high-performing research partners to participate in clinical trials.
  • Oversees all aspects of site visits, including selection, initiation, monitoring, close-out, and support.
  • Serves as the primary point of contact for research partners regarding study-related issues.
  • Manages and supports the Clinical Project Manager (CPM) with various tasks such as vendor management, training, logistics, and study tracking.
  • Contributes to the development of key study documents and prepares/reviews monitoring tools.
  • Tracks monitoring activities and ensures timely data collection.
  • Collaborates with internal and external teams to ensure the study is audit-ready and addresses any findings promptly.

Experience

  • A minimum of 5 years of experience in the pharmaceutical, biotechnology, or contract research industry.
  • Experience in site engagement or an investigator-facing role is preferred.
  • Bachelor's degree in a life science/biological field is preferred.
  • At least three years of experience in monitoring clinical trials, preferably in later phases (2-4).
  • Strong understanding of Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) Guidelines.

Skills and Abilities

  • Strong facilitation and collaboration skills.
  • Excellent communication skills (written, verbal, and presentation).
  • Ability to work effectively in a fast-paced and international environment.
  • Supervisory experience in a clinical trial setting.
  • Ability to work independently, under pressure, and as part of a team.
  • Proficient in Microsoft Office Suite.
  • Strong problem-solving and analytical skills.
  • Ability to travel extensively (including overnight stays).

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