Clinical Operations Specialist

hace 1 semana

Madrid, Madrid, España Pharmiweb A tiempo completo
About the Role

We are seeking a highly skilled and experienced Clinical Operations Specialist to join our team. As a key member of our global clinical operations team, you will play a critical role in ensuring the successful delivery of clinical trials.

Key Responsibilities
  • Provide operational support to clinical trial teams, ensuring timely and efficient delivery of study milestones.
  • Develop and maintain strong relationships with internal stakeholders, including study managers, clinical research associates, and data managers.
  • Collaborate with cross-functional teams to identify and implement process improvements, ensuring compliance with regulatory requirements and company standards.
  • Manage and maintain accurate and up-to-date records, including study trackers, access, and analysis of various reports.
  • Develop and distribute dashboards and reports to study teams, ensuring timely and effective communication of key performance indicators.
  • Provide system-related support, including management of access and study trackers, and analysis of various reports.
  • Manage TMF activities, including both in-house and FSO trials, ensuring timely follow-up with stakeholders to improve TMF compliance.
  • Work closely with SDS/SM to manage activities post-SAC and until final archival.
Requirements
  • Excellent technical/IT skills, with ability to understand the impact of technology on studies and use and develop computer skills.
  • Knowledge of ICH GCP relevant operational procedures, systems, and quality guidelines regarding clinical studies.
  • Able to work independently as well as in a team, with a professional attitude and good customer focus.
  • Very good communication skills, with high English language proficiency.
  • 1-2 years of prior experience in clinical operations as CTA, CPA, or similar.
  • Knowledgeable of main systems (vTMF, mCTMS) and willingness and ability to continuously learn and become highly competent in using sponsor's evolving systems and tech.
What We Offer

We offer a competitive salary, a range of health insurance offerings, competitive retirement planning, and a global employee assistance program. We also offer flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, and subsidised travel passes.

We are committed to providing an inclusive and accessible environment for all candidates. We are an equal opportunities employer and welcome applications from diverse candidates. If you need a reasonable accommodation for any part of the application process, please let us know.

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