Clinical Operations Lead

2 weeks ago

London Area, United Kingdom ARTO Full time

We are seeking a highly motivated and experienced Clinical Project Lead to join our dynamic team. The Clinical Project Lead will play a pivotal role in the planning, execution, and management of clinical research projects focused on women's health. This individual will collaborate with cross-functional teams to ensure the successful implementation of clinical trials, from protocol development to study closeout, while adhering to regulatory requirements and maintaining the highest standards of quality and integrity.


Responsibilities:

  • Lead and oversee the planning, initiation, execution, and completion of clinical research projects related to women's health, ensuring adherence to timelines, budgets, and quality standards.
  • Develop and implement comprehensive project plans, including study protocols, timelines, resource allocation, and risk management strategies.
  • Serve as the primary point of contact for internal and external stakeholders, including clinical investigators, study sites, contract research organizations (CROs), and regulatory agencies.
  • Collaborate with cross-functional teams, including clinical operations, regulatory affairs, medical affairs, and data management, to ensure alignment and effective communication throughout the project lifecycle.
  • Manage and monitor study progress, including patient recruitment, enrollment, data collection, and site performance, and proactively identify and address any issues or deviations from the study plan.
  • Prepare and review study-related documentation, including informed consent forms, case report forms (CRFs), study reports, and regulatory submissions, to ensure compliance with applicable regulations and guidelines.
  • Provide leadership and guidance to project team members, fostering a collaborative and supportive work environment focused on achieving project goals and milestones.
  • Stay current with industry trends, regulatory requirements, and best practices in clinical research, particularly as they pertain to women's health, and apply this knowledge to enhance study design and execution.


Qualifications:

  • Bachelor's degree in a relevant scientific or healthcare discipline; advanced degree (e.g., Master's or Ph.D.) preferred.
  • Minimum of 5 years of experience in clinical research, with a demonstrated track record of managing clinical trials in the pharmaceutical, biotechnology, or medical device industry.
  • Strong understanding of clinical trial design, execution, and regulatory requirements, preferably in the context of women's health indications (e.g., reproductive health, gynecological disorders, menopause).
  • Proven leadership skills with the ability to effectively manage cross-functional teams and drive project execution in a fast-paced, deadline-driven environment.
  • Excellent communication, interpersonal, and problem-solving skills, with the ability to build strong relationships and influence stakeholders at all levels of the organization.
  • Detail-oriented with a commitment to quality and compliance, including familiarity with Good Clinical Practice (GCP) guidelines and other relevant regulations (e.g., FDA, EMA).

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