Senior Clinical Research Associate

Location: located in North Italy; Milan

Optimapharm is a globally operating, leading, mid-sized, full-service CRO aiming to deliver new therapies to improve and save patients' lives.

Optimapharm' s key priorities are the well-being of our people, consistent quality delivery to our clients and healthy, sustainable growth.

With 26 strategically located offices, Optimapharm operates in 40+ countries, providing most optimal access to Patients and Investigators globally. Established nearly 20 years ago, we leverage our experience, stable project teams and collaborative, and flexible approach to secure a high level of repeat business, gain the trust of new customers and secure continued growth of the company.

We're expanding our team in Italy and looking for a new CRA (CRA III - Senior CRA, depending on experience). Whether you're building your expertise as a CRA II or ready to step into a Senior CRA role, this is your chance to shape the future of clinical research - delivering excellence for our sponsors and meaningful impact for patients and families worldwide.

• Working in a successful company that's growing and developing every day
• Working with a highly experienced team of clinical research professionals
• Performance bonus
• Referral bonus
• Flexible work hours
• Home-based position
• Working from home allowance
• Meal vouchers
• Shopping discounts
• Employee engagement programs
• Well-being initiatives
• Training and development program

• University degree, preferably in medical or life sciences; nursing education or other relevant healthcare college degree
• At least 2 - 3 years of independent clinical trial monitoring experience in oncology (solid tumors); gastroenterology experience would be considered as a plus
• High level of knowledge of ICH GCP Guidelines, knowledge of regulatory requirements and a strong interest in clinical research
• Computer proficiency is mandatory
• Ability to read, analyze, and interpret common scientific and technical journals
• Excellent verbal and written communication skills
• Very good interpersonal and negotiation skills
• Ability to work independently, pro-active
• Affinity to work effectively and efficiently in a matrix environment
• A current, valid driver's license

• Perform routine site visits independently, including pre-study, initiation, interim monitoring and closeout visits
• Manage assigned sites by regular contact with site personnel to ensure site compliance, adequate enrolment and understanding of study requirements
• Independently perform CRF review; query generation and resolution against established data review guidelines or data management systems as applicable
• Identifying and escalating potential risks and identifying retraining opportunities for site personnel
• Preparation of corrective and preventive (CAPA) plans for issues identified during monitoring activities and pro-active follow of each, individual CAPA until timely resolution
• Preparation of documents required for EC submissions and notifications, translation of study-related documents (where applicable), and other tasks as instructed by the supervisor
• Independently negotiate study budgets with potential investigators/institutions and assist with the execution of site contracts as applicable
• Administration of site payments in accordance with relevant project instructions

By joining our fast-growing and prosperous team, you will have an excellent opportunity for further personal growth and career development.

If you would be interested in joining the Optimapharm team, please send your CV and note that only shortlisted candidates who meet the requirements will be contacted for the further selection process.

Compensation is competitive and final offers will reflect each candidate's experience, skills, and qualifications.

Disclaimer: Unsolicited CVs sent to Optimapharm (Talent Acquisition Team, Hiring Managers or any other OPT employee) by recruitment agencies will not be considered for this role. Optimapharm follows a direct sourcing strategy and collaborates exclusively with selected recruitment partners when external support is required.