Apellis Pharmaceuticals · 3 hours ago
Clinical Trial Manager
United States
Full-time
Remote
Mid, Senior Level
$129K/yr - $194K/yr
4+ years expApellis 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 Clinical Trial Manager is responsible for the overall management, planning, implementation, and execution of clinical trial(s) in a fast-paced environment with moderate oversight from senior management.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
Leads and/or assists the trial team to execute and deliver the clinical trial in accordance with the clinical development plan/strategy, budget and timeline
Author clinical trial documents and trial-related plans
Contributes to and/or approves with oversight, the clinical review of CRFs, CRF completion guidelines, and the data review plan
Leads/assists in the identification and selection of investigator sites
Responsible for planning, conducting, and presenting during Investigator’s Meetings
Provides input and coordinates the delivery of clinical trial supplies in collaboration with Clinical Supply team as escalate issues as appropriate
Collaborates with the cross-functional team on selection and management of clinical trial vendors
Responsible for providing input to Trial Master File Plan, overseeing Clinical Operations-related documentation, and coordinates with document specialists regarding trial files
Manages and triages escalation of trial-related issues and communicates as appropriate with management and other cross-functional areas
Leads oversight of CRO activities and other clinical vendors to ensure the quality meets Apellis and regulatory requirements
Monitors and manages budget for clinical trial(s) including proposals, contracts, and change orders from CROs and vendors
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, identifies issues/trends as available, and provide oversight and/or serve as escalation point to junior team members
Collaborate with cross-functional team members to monitor the clinical trial data to ensure timely entry, collection, and identification of data quality issues
Provides periodic status reports regarding trial timelines, budget issues, accruals, etc. to management as requested
Responsible for managing one or more clinical trial(s)
Support departmental initiatives and process improvements
Provides input and serves as the subject matter expert for the trial during regulatory inspections
Other duties and responsibilities as required
Qualification
Required
B.S/B.A. degree is required
4+ years' experience working within a pharmaceutical/biotech company, CRO, or similar organization
2+ years' experience managing clinical trials
Must be able to work in a fast-paced environment with demonstrated ability to manage multiple competing tasks and demands
Ability to complete tasks to deadlines (time management) and resolve/escalate problems in a timely manner
Excellent written and verbal communication skills required
Provide review of vendor requests for proposals, scope of work(s), and contract scope changes
Contribute, develop, and manage clinical trial budget(s)
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
Ensure trial adherence to ICH/GCP/local regulations
Lead a cross-functional team within an evolving organization and external vendors
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
More!
Company
Apellis Pharmaceuticals
Apellis Pharmaceuticals focuses on developing novel therapeutics and drug delivery technologies to address chronic inflammatory diseases.
501-1000 employees
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 CompanyTotal Funding
$919.6MKey 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
Cedric Francois
Co-Founder and CEO
Caroline Baumal
Chief Medical Officer
Recent News
2026-01-18
Investor's Business Daily
2026-01-13
Company data provided by crunchbase