Clinical Operations Manager

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $100k - $113k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🏥 Clinical Operations

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• Execute and oversee local operational clinical trial activities at the country level • Own and oversee local regulatory and financial compliance • Deliver country-specific trial commitments and objectives, especially during study start-up • Influence investigators, vendors, external partners, and country managers to deliver commitments • Adhere to budget targets and payment timelines • Address and resolve issues and develop country risk management and mitigation plans • Manage country and site budgets and clinical research-related payments • Reconcile payments at study close-out • Execute and oversee country submissions and approvals for assigned protocols • Develop local-language materials, including informed consents and translations • Work with IRB/IEC and Regulatory Authorities on submission and approval interactions • Manage country deliverables, timelines, and results for assigned protocols • Contribute to local SOP development • Collaborate with clinical operations, quality, finance, medical, regulatory, pharmacovigilance, compliance, legal, regional operations, vendors, sites, IRBs/IECs, and Regulatory Authorities • Align country timelines with Regional Operations and oversee local vendors • Oversee clinical and ancillary supplies, importing/exporting, supplies destruction, filing, archiving, retention, and insurance processes • Enter and update country information in clinical, regulatory, safety, and finance systems • Perform other duties as assigned

🎯 Requirements

• 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 may be considered in lieu of educational requirements • Minimum of four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries or experience in a health care setting may substitute for the educational requirement • Thorough knowledge of ICH Guidelines and GCP • Basic understanding of regulatory requirements in other countries • Thorough understanding of the drug development process • Fluent in local office language and English, written and verbal • Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC, and other applicable regulations/guidelines • Familiarity with investigator start-up documents • Previous interaction with operational project teams and investigative sites preferred • Excellent oral and written communication skills • Good computer skills and working knowledge of a range of computer packages • Ability to lead and develop junior staff • Minimum of four-six (4-6) years of clinical research experience • Ability to work independently and in a team environment, under pressure, and meet deadlines • Detail- and process-oriented • Multi-tasking capability • Flexible and adaptable to a developing work environment

🏖️ Benefits

• Medical insurance • Dental insurance • Vision insurance • Life insurance • Short-term disability (STD) and long-term disability (LTD) • 401(K) • Employee Stock Purchase Plan (ESPP) • Paid time off (PTO) or Flexible time off (FTO) • Company bonus where applicable