Integrated Resources, Inc ( IRI ) · 2 days ago
Clinical Trial Lead
United States
Contract
Remote
Senior Level, Lead/Staff
$110/hr - $115/hr
10+ years expIntegrated Resources, Inc (IRI) is seeking a Clinical Trial Lead to support and lead clinical trials. The role involves overseeing CROs and vendors, managing study budgets and timelines, and ensuring compliance with regulations and operational standards.
BiotechnologyHealth CareHuman ResourcesRecruitingStaffing Agency
Hiring Manager
Shivi Singh
Responsibilities
This position will be responsible for supporting and/or leading clinical trials, including overseeing CROs and vendors
Works cross-functionally on operational strategy and related initiatives
Works collaboratively within Development Operations and across cross-functional teams on the study to ensure successful execution of assigned responsibilities
Manages clinical study budgets, timelines, and resources, focusing on quality and operational strategies to support study and/or program objectives
Responsible for developing clinical development operational plans in support of the study
Oversees execution of studies in compliance with ICH/GCP, local regulations, and Client's SOPs
Provides input into study budget forecasting and is responsible for invoice and budget tracking for individual studies
Supports the selection, oversight, and management of CROs and other vendors
In collaboration with the CRO, oversees site feasibility/capability assessments
Reviews 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
Responsible for representing Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensuring compliance with operational standards and procedures
Represents Client externally to Investigators, site staff, and Key Opinion Leaders
Represents Client Clinical Operations related to study-specific discussions with collaborators/partners, as applicable
Performs and documents study level Sponsor Oversight of outsourced clinical activities
Communicates study-status, cost and issues to ensure timely decision-making by senior management
Oversees/collaborates on and contributes to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct
Maintains oversight of departmental and organizational SOPs metrics for study team to ensure compliance
Leads and/or participate in the creation and review of departmental and organizational SOPs and initiatives
Manages the cross functional team and CRO/vendor(s) related to all aspects of clinical trial operations
Develops collaborative relationships with key stakeholders; internal and external to Client
Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors
Exercises judgments within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
Manages internal staffing and performance management, including hiring, training, coaching, and performance reviews
Mentors and develop Clinical Operations staff
Proposes innovative ideas to help resolve challenges faced by the study team
Strives for continuous improvement and more efficient ways of working in Clinical Operations
Acts as a role model for Client's core values
Qualification
Required
10 years pharmaceutical development experience including managing CROs
3 years previous people management experience is required
Must have demonstrated ability to solve problems with innovative solutions along with strong organizational skills
Excellent written and verbal communication skills in addition to excellent project management skills
Experience and understanding of ICH, and GCP
Must be a demonstrated self-starter and team player with strong interpersonal skills
Must have strong computer skills with a proficiency in Microsoft Project, Word, Excel, Visio, and PowerPoint
Some travel required depending on business needs
A Bachelors degree is required
Preferred
Experience in GCP inspections/audits is highly desired
A Bachelor's or Master's in a scientific discipline is preferred
RN or BSN degree highly desired, equivalent experience may be accepted
Company
Integrated Resources, Inc ( IRI )
Integrated Resources Inc.
501-1000 employees
H1B Sponsorship
Integrated Resources, Inc ( IRI ) has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (5)
2023 (13)
2022 (9)
2021 (25)
2020 (39)
Funding
Current Stage
Late StageRecent News
2025-06-11
2025-06-11
2025-04-14
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