Clinical Trial Manager

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.

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.

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.

Physical Demands and Work Environment:

This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary. This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Travel Requirements:

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

Benefits and Perks:

Apellis offers a comprehensive benefits package, including a 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! Visit https://apellis.com/careers/benefits/ to learn more.

Company Background:

Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy, a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targeting C3 across many serious diseases.

For more information, please visit http://apellis.com or follow us on Twitter and LinkedIn

 EEO Statement:

Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law.

For San Francisco postings: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.  

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.