Operations Manager, Clinical Trials at PSI CRO

Bucharest, , Romania -

Full Time

Start Date

Immediate

Expiry Date

13 Oct, 26

Salary

0.0

Posted On

15 Jul, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Trial Management, Team Leadership, ICH GCP, Budget Negotiation, Stakeholder Management, Protocol Feasibility Assessment, Audit Supervision, Performance Evaluation, Strategic Partnerships, Project Monitoring, Communication Skills, Problem Solving

Industry

Pharmaceutical Manufacturing

Description

Company Description At Milestone One, we’re transforming access to clinical trials by expanding research site networks and fostering strategic partnerships with medical institutions. Our mission is to connect patients, physicians, and sponsors in a seamless ecosystem that accelerates breakthrough treatments. With over 30 years of global experience, we are a team of industry experts dedicated to quality, innovation, and collaboration. As our Operations Manager, you’ll play a key role in driving our business expansion through leading the local team and building strong, long-term partnerships with clinical research organizations and medical institutions. Job Description Assesses feasibility of research protocols based on knowledge and experience and in accordance with designated criteria to select the most suitable studies for the clinical site. Supervises the conduct of clinical trials in accordance with ICH GCP, applicable regulations, procedures, and protocols, by monitoring the safety of patients, completeness of research documentation and proper study conduct. Monitors individual stages of budget negotiations and research timelines. Manages the team of Lead Coordinators, oversees the quality and results of their work by monitoring and follow-up of study related reports, timesheets, site trackers and any other available tools to ensure satisfactory performance of the MO1 team. Ensures continuous improvement and standardization of the research process, its continuity and consistency with ICH GCP, regulations, procedures and research protocols by co-creating operational procedures, templates, guidelines related to the work of medical staff and the site in clinical studies. Creates a work culture environment that promotes process transparency, high performance and openness. Manages and supervises the teams’ work, ensuring the development of individual team members through regular, open feedback, periodic support meetings, providing training and guidance. Provides performance evaluation in accordance with the employee evaluation system to maintain motivation and commitment at work. Supervises and participates, when necessary, in audits and inspections, supports the Milestone One team and the medical team at the site by ensuring a reliable and smooth audit process. Build and sustain long-lasting relationships with existing and potential clients (sponsors, CROs, medical institutions). Support network development activities by active promotion of Milestone One brand by acquiring new clinics and new medical institutions to the network. Qualifications University degree in life sciences Minimum 5 years of a clinical on the job experience, in a leadership position at a CRO or SMO Fluent use of local language, at least C1 level of English Proficiency in MS Office Valid driver’s license Excellent communications and presentation skills Excellent Management Skills Effective problem solving and result oriented Accountable Team Leadership Skills Additional Information Accelerate your career with Milestone One!

Responsibilities

The Operations Manager leads the local clinical trial team and oversees the conduct of studies in compliance with ICH GCP and regulatory standards. They are responsible for building strategic partnerships with CROs and medical institutions while ensuring operational efficiency and quality.