Clinical Operations Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Execute and manage local operational clinical trial activities at the national level

• Take ownership of local regulatory and financial compliance

• Achieve country-specific trial commitments and objectives, particularly during study initiation

• Influence investigators, vendors, external partners, and country managers to fulfill commitments

• Maintain adherence to budget targets and payment schedules

• Identify and resolve issues while developing country risk management and mitigation strategies

• Oversee country and site budgets along with clinical research-related payments

• Reconcile payments during study close-out

• Execute and manage country submissions and approvals for designated protocols

• Create local-language materials, including informed consent documents and translations

• Collaborate with IRB/IEC and Regulatory Authorities on submission and approval processes

• Manage country deliverables, timelines, and outcomes for assigned protocols

• Contribute to the development of local SOPs

• Work in conjunction 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 supervise local vendors

• Oversee clinical and ancillary supplies, including importing/exporting, supplies destruction, filing, archiving, retention, and insurance processes

• Input and update country information in clinical, regulatory, safety, and finance systems

• Perform additional duties as assigned

⛳️ Requirements

• Bachelor's or college degree (preferably in life sciences), or a certification in a related allied health profession from an accredited institution, nursing certification, medical, or laboratory technology

• Relevant and equivalent experience may be accepted in place of formal educational requirements

• A minimum of four (4) years of relevant clinical research experience in pharmaceutical or CRO industries, or experience in a healthcare setting may substitute for educational qualifications

• Comprehensive knowledge of ICH Guidelines and GCP

• Basic understanding of regulatory requirements in various countries

• In-depth understanding of the drug development process

• Fluency in the local office language and English, both written and verbal

• Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC, and other relevant regulations/guidelines

• Familiarity with investigator start-up documentation

• Previous experience interacting with operational project teams and investigative sites is preferred

• Exceptional oral and written communication skills

• Proficient computer skills and familiarity with a variety of software applications

• Capability to lead and mentor junior staff

• At least four to six (4-6) years of clinical research experience

• Ability to work independently and collaboratively in a team setting, under pressure, and to meet deadlines

• Detail-oriented and process-focused

• Ability to manage multiple tasks simultaneously

• Flexibility and adaptability to a dynamic 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