[Hiring] Clinical Research Manager @Fortrea

Role Description

The CRM is 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 in compliance with ICH GCP and country regulations. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives, especially during the study.

• Accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards, and adverse event reporting requirements internally and externally.
• Point of contact for assigned protocols, driving and tracking execution and performance of deliverables/timelines/results to meet country commitments.
• Responsible for quality and compliance in assigned protocols in country, overseeing CRAs and CTCs on assigned projects.
• Collaboration with functional outsourcing vendors, investigators, and other external partners.
• Collaborates internally with local PV, Regulatory, GMA/GHH to align on key decisions in countries.

Qualifications

• University/college degree (life science preferred) or certification in a related allied health profession from an appropriately accredited institution.
• Minimum of four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries or experience in a health care setting will be considered.
• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries.
• Fluent in local office language and in English, both written and verbal.
• Focus on Customer, Innovate and Change, Pursue Scientific and Process Excellence, Work with Others, Achieve Results.

Requirements

• Minimum of six-eight (6-8) years of clinical research experience.
• Good organizational and time management skills.
• Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC, and other applicable regulations/guidelines.
• Excellent communication skills, oral and written.
• Self-motivation with the ability to work under pressure to meet deadlines.
• Detail and process oriented.
• Interact with internal and external customers with high degree of professionalism and discretion.
• Multi-tasking capability.
• Good computer skills with good working knowledge of a range of computer packages.
• Ability to lead and develop junior staff.
• Flexible and adaptable to a developing work environment.

Benefits

• Client office as per assignment.
• Travel Requirements: ≤ 20-40 % travel may be required.
• International and Domestic Travel may be required, including overnight stays as necessary consistent with project needs and office location.