Clinical Research Operations Manager

2 settimane fa


Roma, Lazio, Italia Fortrea A tempo pieno
About Fortrea

Fortrea is a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas.

Job Title: Clinical Research Operations Manager

Estimated Salary: $120,000 - $180,000 per annum

Job Description:Critical Responsibilities

We are seeking an experienced Clinical Research Operations Manager to join our team in this role, accountable for execution and oversight of local operational clinical trial activities and has ownership, oversight, and impact on local regulatory and financial compliance, at a country operations level at the client.

The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up. The ability to indirectly influence investigators, vendors, external partners, and country managers to deliver these commitments is a must.

This includes adhering to budget targets and agreed payment timelines, addressing and resolving issues, maintaining expertise in country-based regulations, laws, and procedures with minimal support from the client management.

The ideal candidate will have thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries, a thorough understanding of the drug development process, fluency in English, both written and verbal, and good organizational and time management skills.

Responsibilities include but are not limited to:

  • Oversight and tracking of clinical research-related payments
  • Payment reconciliation at study close-out
  • Execution and oversight of clinical trial country submissions and approvals for assigned protocols
  • Development of local language materials including local language Informed Consents and translations
Requirements

To be successful in this role, you will need:

  • A University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution
  • Nursing certification, medical or laboratory technology, relevant and equivalent experience in lieu of educational requirements
  • A minimum of four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries or experience in a healthcare setting
  • Excellent communication skills, oral and written
  • Self-motivation with the ability to work under pressure to meet deadlines
  • Works well independently and in a team environment
About Us

Fortrea is proud to be an Equal Opportunity Employer: As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.



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