Senior Clinical Trial Manager

3 weeks ago

Waltham, United States Apellis Full time
Job DescriptionJob 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.
  • Authors and/or approves 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 overseeing the identification and selection of investigator sites.
  • Responsible for planning, conducting, and presenting during Investigator Meetings.
  • Provides input and coordinates the delivery of clinical trial supplies in collaboration with the Clinical Supply team, while identifying, mitigating, and escalating potential issues as appropriate.
  • Collaborates with the cross-functional team on the selection and management of clinical trial vendors.
  • Responsible for providing input to the Trial Master File Plan, overseeing Clinical Operations-related documentation, and coordinating with document specialists regarding trial files.
  • Escalates and/or addresses trial-related issues, communicating with management and other cross-functional areas as appropriate.
  • Oversees CRO and other clinical vendor performance and activities to ensure quality meets Apellis and regulatory requirements and serves as the primary escalation point.
  • Develops, monitors, and manages budgets for clinical trials, including proposals, contracts, and change orders from CROs and vendors.
  • Attends periodic visits to sites and/or CROs to assess trial progress, protocol compliance, and build relationships.
  • Ensures compliance with monitoring and monitoring oversight plans, identifying and escalating trends as appropriate.
  • Collaborates with cross-functional team members to monitor clinical trial data, ensuring timely entry, collection, and identification of data quality issues.
  • Provides periodic status reports regarding trial timelines, budget issues, accruals, etc., to management as requested.
  • Mentors other Clinical Operations team members.
  • Responsible for managing multiple clinical trials with varying levels of complexity.
  • Supports and recommends potential departmental initiatives and process improvements.
  • Provides input and serves as the subject matter expert for the trial during regulatory inspections.
  • Up to 25% domestic and/or international travel.
  • 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 t0 20% travel expected.

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/ 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.

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