Job Specifications
Clinical Operations Lead – Early Clinical Stage Development
6-month contract
Hybrid - 3 days/week onsite in Waltham, MA
Role and Responsibilities
Develop strategy and methodology for clinical operations programs.
Ensure clinical trials are conducted in compliance with applicable regulatory requirements and are inspection-ready.
Oversee planning, execution, and delivery of clinical programs/trials from Start of Development through Proof of Clinical Principle/Concept within assigned indications or assets, emphasizing speed and value.
Manage budgets and timelines while supporting implementation aligned with relevant local regulations and international ICH-GCP guidelines.
Provide operational and strategic input on training materials, program-specific standards, clinical development plans, and clinical sections of regulatory documents (e.g., Investigator Brochure, clinical study reports, safety updates, briefing books, submission dossiers).
Ensure timely execution and contribute to asset evidence plans and clinical trial protocols.
Collaborate with Clinical Trial Supply to determine comparator sourcing strategy when applicable.
Drive site selection and subject recruitment programs to meet enrollment targets.
Participate in database creation and user acceptance testing; provide input on edit checks, monitoring guidelines, and data cleaning activities between study sites, data management, and field monitors.
Participate in SOP development, process mapping, training of CTAs, and other departmental activities.
Partner and liaise with internal team members globally, including technical leads, project management, and regulatory affairs.
Minimum Education & Experience Requirements
M.S. or Ph.D. in basic sciences with 5+ years of Clinical Operations experience within a biotechnology, pharmaceutical company, or CRO.
Ability to identify and champion more efficient and effective methods/processes for delivering Clinical Operations, focusing on key performance metrics including reliability, efficiency, cost, and quality.
Thorough knowledge of FDA and/or EMEA regulations, ICH guidelines, and GCPs governing clinical trials. Experience leading global trials outside the U.S./EU/Asia/Americas is preferred.
Advanced experience with patient recruitment, non-compliance, safety, document management, investigational product, and budget management.
Demonstrated experience in successful planning and implementation of clinical trial operations.
Experience developing clinical protocols, SOPs, clinical study reports, and other documents to support New Drug Applications (NDA) on time, within budget, and in compliance.
Proven track record of leading and driving business process transformation and organizational culture change, as well as delivering on programs with complex business requirements.
About the Company
- Multi-Year Award Winner Inc. 5000's America's Fastest Growing Companies
- Awarded Best Places to Work in IL every year from 2018-present
- Multi-Year Award Winner "Best Staffing Firm to Work For" by Staffing Industry Analysts
- Awarded Best of Staffing - Talent Satisfaction by ClearlyRated from 2019-present
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