Sr Clinical Operations Consultant (remote position)Apply Now
Employment Type: Contract
Contract Length: 12+ months
This position is 100% remote
Job Summary: Seeking a Sr. Consultant in Clinical Operations to manage Infectious Disease programs which may consist of one or more studies. This position will be responsible for initiating and leading clinical trials across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives. This position reports to the Senior Director, Clinical Operations within the Infectious Disease Therapeutic Area. This position will work collaboratively across the Infectious Disease teams and cross-functional teams on the overall development programs and related studies to ensure successful execution of assigned projects.
- Accountable for delivery of assigned clinical program/studies budget, timelines, and resource management with focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives
- Develop operational strategy and clinical operations plans in support of execution of the Clinical Development Plan
- Partner and collaborate with cross-functional stakeholders such as the Project Leader, Clinical Lead and other relevant stakeholders
- Lead and oversee execution of first-in-human through phase 4 trials, depending on lifecycle of program, in compliance with ICH/GCP, local regulations, and SOPs
- Support the selection, oversight, and management of CROs and other vendors
- Oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team
- Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
- Manage the cross functional team and CRO/vendor(s) related to all aspects of clinical trial operations
- Minimum of BA/BS with at least 5-8 years of trial and clinical program experience. Advanced degree preferred.
- Experience in vaccine development highly desired.
- Solid experience in early and late phase drug development.
- Multi-dimensional Clinical Operations background with capability of devising plans for operational challenges such as site activation, subject enrollment, monitoring oversight, protocol deviation management, data cleaning, etc.
- Cross-Collaboration proficiency with other functions such as Regulatory, CMC, Biostatistics, Data Management, Finance, Program Management, etc.
- Experience in GCP inspections/audits
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