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Beacon Hill · 9 hours ago

Clinical Operations Lead - Oncology

United States

Contract

Remote

Senior Level

$70/hr - $90/hr

6+ years exp

Beacon Hill is a company focused on clinical operations, and they are seeking a Clinical Operations Lead specializing in Oncology. The role involves overseeing clinical trials, managing vendors, and ensuring compliance with regulations while collaborating with various stakeholders.

Staffing Agency

H1B Sponsor Likely

Hiring Manager

Annie Crittenden

Responsibilities

Support the study team to ensure trials are initiated efficiently and completed on time, within budget, and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines with minimal supervision

Collaborate with study team to develop, review, and facilitate Request for Proposals (RFPs), and contribute to bid defense meetings to select CROs and other clinical vendors for strategic fit

Manage various clinical vendors to ensure project and corporate goals are achieved on time and within budget

Oversee site management activities (e.g., review of monitoring reports, recruitment, quality metrics) in collaboration with CRO

Actively manage and resolve site issues in collaboration with internal functional lines and CRO partners

Contribute to development and review of key clinical documents (e.g., protocols, informed consent forms (ICFs), case report forms (CRFs), study reference manuals, study plans)

Serve as subject matter expert (SME) on departmental initiatives and participate in SOP and process development and implementation

Oversee fiscal and contracts management: manage vendor contracts, forecast financials, reconcile invoices, and ensure accuracy of CRO/vendor work orders and change orders

Participate in implementation and oversight of clinical systems including CTMS, TMF, EDC, and IRT

Conduct clinical data review of listings and summary tables, including query generation

Support other study activities as needed (e.g., site selection, start-up, recruitment, protocol deviation and TMF review)

Review and track key study metrics and progress reports; anticipate obstacles and implement creative solutions to achieve project goals and timelines

Proactively identify potential study risks, recommend mitigation strategies, and facilitate discussions with stakeholders for implementation

Establish and maintain strong relationships with internal teams, CROs, vendors, and clinical research site personnel for successful trial execution

Train investigators, site staff, vendors, and team members on study protocol and trial conduct processes

Ensure TMF is set up and maintained appropriately throughout the trial and conduct periodic reviews/QCs

Ensure trials are inspection-ready at all times and participate in QA and/or regulatory authority audits as needed

Occasional domestic and international travel may be required

Perform other duties as assigned

Qualification

Clinical study managementVendor managementOncology expertiseFDA regulations knowledgeICH/GCP guidelines knowledgeAnalytical skillsRelationship-building skillsCommunication skillsDetail-orientedCreative thinking

Required

Bachelor's degree in life sciences or related discipline with 6+ years of experience in clinical and drug development

Advanced knowledge of domestic and global clinical study management and vendor management experience in oncology, including interpretation and implementation of FDA and ICH/GCP regulations and guidelines

Self-motivated, results-oriented, and collaborative team player with strong relationship-building skills

Detail-oriented and creative thinker with a passion for process optimization

Excellent organizational, analytical, and communication (verbal and written) skills in a fast-paced environment

Ability to analyze and triage problems, prioritize accordingly, and propose solutions

Ability to travel as required

Preferred

Early-phase oncology trial management experience preferred, including precision medicine trials

Company

Beacon Hill

Glassdoor3.9

Beacon Hill was founded to set a new standard in search, career placement and flexible staffing.

Founded in 2000

Boston, Massachusetts, USA

1001-5000 employees

http://www.beaconhillstaffing.com

H1B Sponsorship

Beacon Hill 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 (38)

2024 (94)

2023 (76)

2022 (60)

2021 (77)

2020 (86)