Apellis Pharmaceuticals

Clinical Trial Manager

Apellis Pharmaceuticals

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Job Level

Mid-LevelSenior

Tech Stack

Google Cloud Platform

About the role

  • 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 the Senior Clinical Trial Managers and/or Associate Director, Clinical Operations.
  • 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.

Requirements

  • B.S/B.A. degree is required. Science/health care related field preferred but not required.
  • 5+ years' experience working within a pharmaceutical/biotech company, CRO, or similar organization.
  • 2+ years’ experience managing clinical trials.
  • Ophthalmology, Nephrology, Hematology experience preferred.
  • 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.