Senior Clinical Trial Manager

Opportunity awaits those up to the challenge of developing transformative therapies across a broad range of debilitating diseases.

Summary:

Roles and Responsibilities:

Responsibilities:

• Ensure trial adherence to ICH/GCP/local regulations.
• Assisting with the development of high-quality monitoring report templates and plans
• Ensure country and site selection meet study requirements.
• Reviewing monitoring reports and escalating monitoring and/or data integrity issues as appropriate
• Ensure accuracy and timeliness of vendor and site payments.
• Ensuring the validity, correctness, and completeness of clinical data reviewed and collected as dictated by study plans and the protocol
• Ensure availability of clinical/non-clinical supplies.
• Provide input for clinical trial plans and documents as required
• Ensure internal and external systems are updated in a timely manner (CTMS, clinicaltrials.gov).
• Maintain and oversee the Trial Master File.
• Identify, address, and communicate quality and compliance concerns.
• Ensure inspection readiness internally and externally.
• Provides regular study activity status updates as requested.
• Communicate effectively with internal and external study personnel (investigative site staff, monitors, Project Managers).
• Other duties and responsibilities as required.

Qualifications:

• Bachelor's Degree required.
• Experience in ophthalmology not required but preferred.
• 5+ years' experience managing clinical trials within biotech, pharmaceutical or medical device environment.

Skills, Knowledge & Abilities:

• Excellent verbal and written communication skills.
• Experience in a start-up environment preferred.
• Must be pro-active team player, flexible, and open to change.
• Knowledge of GCP and ICH.
• Experience developing monitoring plans and report templates
• Experience in multiple phases of research preferred.

Travel Requirements:

Education:

Pay Information:

Work Arrangement:

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 leading the way in complement science 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 C3-targeting medicines approved to treat four serious diseases. Breakthroughs for patients include the first-ever therapy for geographic atrophy, a leading cause of blindness, and the first treatment for patients 12 and older with C3G or primary IC-MPGN, two severe, rare kidney diseases. We believe we have only begun to unlock the potential of targeting C3 across many serious diseases.

For more information, please visit http://apellis.comor follow us on LinkedIn andX.

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.