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Beacon Hill · 3 weeks ago

Remote - Regional Clinical Operations Lead

United States

Contract

Remote

Senior Level, Lead/Staff

$80/hr - $90/hr

8+ years exp

Beacon Hill is a highly reputable biotechnology corporation seeking a qualified Regional Clinical Operations Lead to work remotely in the United States. The role involves overseeing and managing clinical trials, collaborating with cross-functional teams, and ensuring compliance with regulations. The Lead will also manage clinical vendors and contribute to the development of key clinical documents.

Staffing Agency

H1B Sponsor Likely

Hiring Manager

Andrew Osborn

Responsibilities

Responsible for the regional operational execution, oversight and management of one or more clinical trials from start-up through close out for early stage clinical programs

As a Regional Lead, you will work directly with cross-functional representatives including Medical Monitor, Clinical Science, Clinical Data Management, Regulatory, Biostatistics, Pharmacology and Translational Science and other key functions both internally and externally to ensure successful completion of all clinical activities/project deliverables

Support the Study Lead and Study Execution Team (SET) to ensure trials are initiated efficiently and completed on time, within budget and in compliance with Standard Operation Procedures (SOPs), FDA regulations and ICH/GCP guidelines with minimal supervision

In collaboration with SET, develop, review and facilitate Request for Proposals (RFPs), and contribute to bid defense meetings to select Contract Research Organizations (CROs) and other clinical vendors for the right strategic fit

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

Contribute to development and review 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 various company/department initiatives and participate in the development, review and implementation of departmental SOPs and processes Fiscal and contracts management: oversee and manage vendor contracts, forecast financials in partnership with finance, reconcile invoices against accruals, ensure accuracy of all CRO/vendor work order and change order updates

Participate in implementation and oversight of clinical systems including but not limited to CTMS, TMF, EDC and IRT

Clinical data review of data listings and summary tables, including query generation

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

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

Provide input and support in development and review of key study documents including protocols, ICFs, CRFs, study plans, Clinical Study Reports (CSR), as appropriate

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

Risk management: Proactively identify potential study risks, recommend mitigation strategies/solutions and facilitate discussions with internal and external stakeholders for implementation

Establish and maintain strong relationships with internal cross-functional teams, CROs and vendors, and clinical research site personnel for successful execution of clinical trials

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

Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial and conduct periodic TMF reviews/QCs, as needed

Ensure the clinical trial(s) are inspection ready at all times and participate in Quality Assurance and/or regulatory authority inspection audits, as needed

May require occasional domestic and international travel

Perform other duties as assigned

Qualification

Clinical operations experienceOncology clinical trial experienceFDAICH/GCP knowledgeVendor management experienceClinical study managementAnalytical skillsCommunication skillsTeam playerDetail-orientedCreative thinker

Required

Bachelors Degree in life sciences or related discipline

8+ years of experience in clinical operations and drug development

5+ years of oncology clinical trial experience

5+ years of working for a biotechnology or pharmaceutical corporation

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 and strive for continuous improvement and embrace innovative ideas in daily work

Results-oriented team player; enjoy working collaboratively with colleagues and building positive relationships

Detailed oriented and creative thinker with a passion for process optimization

Excellent organizational, analytical and communication (verbal and written) skills in a fast-paced, and rapidly growing dynamic company

Analyze and triage problems, prioritize accordingly, and propose solutions

Must be able to work PST hours

Ability to travel as required (up to 40%)

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)