Clinical Operations Contractor Jobs

The Clinical Operations Contractor provides operational expertise for one or more clinical programs, which includes one or more cross-functional Clinical Study Teams (phase 1-3). This individual is responsible for the successful execution of program strategy as well as trials from the protocol concept through the clinical trial report, ensuring timely and efficient delivery of all program and study deliverables, in accordance with the appropriate quality standards including ICH/GCP and applicable regulations. Also responsible for oversight of Clinical Research Organizations (CROs) and other third-party vendors and works closely with cross-functional members of the Project Team (PT) and Clinical Study Team (CST).

Responsibilities:

• Provide operational expertise at the Project level for one or more programs
• Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team
• Assist with the identification and selection of appropriate CROs and third-party study vendors, and ensure appropriate cross-functional input is included in the scope of work
• Identify program risks, and proactively create sand implement mitigation strategies
• Establish and maintain good working relationships with investigators and study staff
• Collaborate with Vendor Management in creating and managing study finances, including, but not limited to, budget creation, negotiation and maintenance, invoice and payment management
• Assist with any other tasks as requested
• Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures
• Identify and develop best practices
• Provide guidance/mentorship to Clinical Trial Managers and/or Clinical Program Associates
• Oversee performance of CROs and 3rd-party vendors to ensure compliance with study protocol and in accordance with scope of work, escalating as needed
• Analyze the feasibility data received from the CRO and makes decisions for the strategic country, site distribution, and patient numbers
• Develop relationships with key thought leaders to support product development and represent externally in applicable scientific and medical forums
• Collaborate with Data Management to oversee data quality issues (query and data quality management and resolution)
• Create and manage program and study timelines, including study team goal and milestone creation, and monitoring progress
• Identify and communicate program risks, and proactively create and implement mitigation strategies
• Oversee CRO TMF management and maintenance checks
• Contribute to the development of clinical protocols, amendments, informed consent forms, study guides, lab manuals, case report forms, study plans and any other clinical research related documents, in collaboration with cross-functional team members or CRO partners

Qualifications:

• Ability to apply critical thinking and streamline work
• Strong influencing, negotiation, and conflict resolution skills to build relationships internally and externally at all levels of seniority, and achieve alignment and commitment to deliverables
• Must have experience creating and managing complex study budgets with a focus on financial management of vendors
• Detail oriented with the ability to work independently and manage multiple competing priorities under pressure
• Strong leadership and motivational skills developed through leading successful multi-functional matrix study teams through all stages of clinical studies
• Self-motivated, critical thinker, and able to work with minimal oversight
• Experienced in developing and executing plans including, but not limited to, study goal, milestone, and risk management plans
• Strong understanding of GCP/ICH guidelines and the clinical development process
• BA/BS in a relevant scientific discipline or equivalent combination of education/experience in science or a health-related field is required
• Minimum 10 years’ clinical trial clinical trial leadership experience in the pharmaceutical industry or equivalent is required
• Minimum 2 years’ oncology experience is required
• Proficient computer skills
• Excellent oral and written communication skills
• Strong vendor management experience, from selection to management, and issue escalation. Experience developing and ensuring adherence to scope of work