POSITION SUMMARY:

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.

EDUCATION, REGISTRATION & CERTIFICATION:

• B.S/B.A. degree is required. Science/health care related field preferred but not required.

EXPERIENCE:

• 5+ years’ experience working within a pharmaceutical/biotech company, CRO, or similar organization.
• 2+ years’ experience managing clinical trials.
• Ophthalmology, Nephrology, Hematology experience preferred.

SKILLS, KNOWLEDGE & ABILITIES:

• 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.

TRAVEL REQUIREMENTS:

• Up to 25% domestic and/or international travel.

KEY RESPONSIBILITIES INCLUDE:

• 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.

OTHER DUTIES:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.