Senior Clinical Trial Manager - Waltham, United States - Apellis Pharmaceuticals

Description

Position Summary:

The Senior Clinical Trial Manager is responsible for oversight and the overall management, planning, implementation, and execution of clinical trial(s) in a fast-paced environment with minimal oversight from the Associate Director/Director, Clinical Operations. The Senior Clinical Trial Manager actively contributes to and supports an environment of learning and process improvement.

Key Responsibilities Include:

• Leads and/or oversees the trial team to execute and deliver the clinical trial in accordance with the clinical development plan/strategy, budget, and timeline.
• Author and/or approve clinical trial documents and trial-related plans.
• Responsible for the clinical review and/or approval of CRFs, CRF completion guidelines, and the data review plan.
• Responsible for oversight of 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 well as identifies/mitigates/escalates any potential 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.
• Escalates and/or addresses trial-related issues and communicates as appropriate with management and other cross-functional areas.
• Oversees CRO and other clinical vendor performance and activities to ensure the quality meets Apellis and regulatory requirements and serves as the primary escalation point.
• Develops, 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 and relationship building.
• Ensures compliance with monitoring and monitoring oversight plans and identifies/escalates trends as appropriate.
• 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.
• Mentor other Clinical Operations team members.
• Responsible for managing multiple clinical trial(s) with varying levels of complexity.
• Support and recommend potential 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:

• 6+ years' experience working within a pharmaceutical/biotech company, CRO, or similar organization.
• 3+ years' experience managing clinical trials.

Skills, Knowledge & Abilities:

• Proven ability to work in a fast-paced environment with demonstrated ability to prioritize and manage multiple competing tasks and demands.
• Proactively identify issues/problems and provide solution-oriented resolutions/mitigations.
• Excellent written and verbal communication skills required.
• Ability to collaborate, manage and communicate effectively with vendors including reviewing requests for proposals, scope of work(s), and contract scope changes.
• Contribute, develop, and manage clinical trial budget(s) directly and/or provide support and oversight to the process for more junior team members.
• 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.
• Successfully lead and serve as an escalation point for cross-functional teams 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. 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 great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more Visit 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 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.