Associate Clinical Trial Manager jobs in United States
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Apellis Pharmaceuticals · 4 hours ago

Associate Clinical Trial Manager

Apellis Pharmaceuticals is a global biopharmaceutical company leading the way in complement science to develop life-changing therapies for some of the most challenging diseases patients face. The Associate Clinical Trial Manager will assist in the overall management, planning, implementation, and execution of clinical trials with significant oversight, ensuring trials are conducted in accordance with development plans, budgets, and timelines.

BiotechnologyHealth CarePharmaceuticalTherapeutics
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Assists the trial team to conduct the clinical trial in accordance with the clinical development plan/strategy, budget, and timeline
Contributes to clinical trial documents and trial-related plans
Participates in the clinical review of CRFs, CRF completion guidelines, and data review plan
Assists in the identification and selection of investigator sites
Assists and/or participates in planning and conduct of investigator’s Meetings
Provides input and coordinates the delivery of clinical trial supplies in collaboration with Clinical Supply team
Collaborates with the cross-functional team on selection of clinical trial vendors
Liaises and coordinates with document specialists regarding Trial Master Files
Manages escalation of trial-related issues and communicates as appropriate with management and other cross-functional areas
Assists with oversight of CRO activities and other clinical vendors to ensure the quality meets Apellis and regulatory requirements
Assists with monitoring and managing budget for clinical trial(s) including proposals, contracts, and change orders from CROs and vendors
May attend periodic visits to sites and/or CROs to assess progress of trials/protocol compliance
Reviews clinical monitoring reports and correspondence related to monitoring visits and identifies issues/trends as available working closely with CRO partners
Assists in review of protocol deviations, clinical monitoring reports, risk logs, and other key trial-related documents
Responsible for managing one or more clinical trial(s) with support from senior team members
Support departmental initiatives and process improvements
Familiarity with Regulatory Agency inspection requirements
Other duties and responsibilities as required

Qualification

Clinical trial managementRegulatory requirements knowledgeProject management softwareBudgetingForecastingICH/GCP knowledgeCommunication skillsOrganizational skillsAttention to detail

Required

B.S/B.A. degree is required
2+ years' experience managing clinical trials
2+ years' experience working within a pharmaceutical/biotech company, CRO, or similar organization
Proven ability to organize and manage multiple priorities and/or projects
Proven time management, planning, and organizational skills required
Proven written and verbal communication skills required
Attention to detail and thorough follow-up skills
Familiarity with financial budgeting and forecasting/reporting
Strong knowledge of applicable computer and project management software packages, including Microsoft Suite
Knowledge of current regulatory requirements and guidelines governing clinical research and related terminology
Knowledge and understanding of ICH/GCP/local regulations and applicability to trial(s)
Ability to work successfully within a cross-functional team within an evolving organization, investigational sites, and external vendors
Travel Requirements: Up to 25% domestic and/or international travel

Preferred

Science/health care related field preferred but not required

Benefits

401(k) plan with company match
Inclusive family building benefits
Flexible time off
Summer and winter shutdowns
Paid family leave
Disability and life insurance
And more!

Company

Apellis Pharmaceuticals

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Apellis Pharmaceuticals focuses on developing novel therapeutics and drug delivery technologies to address chronic inflammatory diseases.

H1B Sponsorship

Apellis Pharmaceuticals 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 (11)
2024 (6)
2023 (6)
2022 (8)
2021 (7)
2020 (3)

Funding

Current Stage
Public Company
Total Funding
$919.6M
Key Investors
Swedish Orphan BiovitrumSixth StreetNorthern Star Partners
2025-06-01Post Ipo Debt· $275M
2024-05-14Post Ipo Debt· $475M
2022-04-14Post Ipo Equity· $1.07M

Leadership Team

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Cedric Francois
Co-Founder and CEO
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Caroline Baumal
Chief Medical Officer
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Company data provided by crunchbase