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Clinical Operations Manager at Milestone One | Bucharest

Milestone OneBucharest
On-site Full-time

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Experience Level

Mid to Senior

Qualifications

Bachelor's degree in life sciences or a related field. A minimum of 5 years of clinical experience, with at least 2 years in a leadership role within a CRO or SMO. Fluency in the local language and a minimum of C1 level proficiency in English. Proficient in MS Office applications. A valid driver's license. Exceptional communication and presentation skills. Strong management capabilities. Effective problem-solving skills and a results-driven mindset. Accountability and responsibility in all tasks. Demonstrated team leadership abilities. Experience in induction training in SOPs and administrative practices for SEO Managers, with on-the-job training under the supervision of a designated Project Manager. Sales skills and experience in client engagement are a significant advantage.

About the job

  • Evaluate the feasibility of clinical research protocols based on your expertise and established criteria to identify the most suitable studies for our clinical site.
  • Oversee the execution of clinical trials in compliance with ICH GCP guidelines, relevant regulations, and study protocols, ensuring patient safety and thorough research documentation.
  • Track and manage budget negotiations and research timelines effectively.
  • Lead a team of Lead Coordinators, ensuring the quality and outcomes of their work through diligent monitoring of study-related reports, timesheets, site trackers, and other performance tools.
  • Drive continuous improvement and standardization of research processes, ensuring alignment with ICH GCP, regulations, and protocols by co-developing operational procedures, templates, and guidelines for medical staff.
  • Cultivate a work environment that fosters transparency, high performance, and openness.
  • Supervise team performance and facilitate the development of individual team members through regular feedback, support meetings, and training opportunities. Conduct performance evaluations to sustain motivation and commitment.
  • Participate in audits and inspections as necessary, supporting the Milestone One team and the medical staff to ensure a smooth and reliable audit process.
  • Establish and maintain long-term relationships with existing and potential clients, including sponsors, CROs, and medical institutions.
  • Enhance network development efforts by actively promoting the Milestone One brand and acquiring new clinics and medical institutions for our network.

About Milestone One

At Milestone One, we are pioneering the transformation of access to clinical trials by expanding our research site networks and nurturing strategic partnerships with medical institutions. Our mission is to seamlessly connect patients, physicians, and sponsors to accelerate breakthrough treatments. With over 30 years of global expertise, our dedicated team of industry professionals champions quality, innovation, and collaboration. As the Clinical Operations Manager, you will be instrumental in driving our business expansion by leading the local team and forging robust, long-lasting partnerships with clinical research organizations and medical institutions.

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