Manager, Monitoring Oversight

Clinical Waltham, Massachusetts


Description

Apellis is a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, which is an integral component of the immune system, at the level of C3, the central protein in the complement cascade.

We believe that our lead product candidate, APL-2, has the potential to be a first-in-class treatment targeting C3 that may address the limitations of existing treatment options or provide a treatment option where there currently is none. APL-2 has already shown activity that we believe is clinically meaningful in clinical trials for two distinct medical conditions—geographic atrophy in age-related macular degeneration (GA) and paroxysmal nocturnal hemoglobinuria (PNH). We plan to conduct additional clinical trials in GA, PNH, autoimmune hemolytic anemia (AIHA) and complement-dependent nephropathies.

To support our clinical trials activities and forecast, our Clinical Operations team is growing! This is an exciting time to be joining an organization in a growth phase and truly be a part of building a best-in-class clinical team.

Position Summary:

The Manager, Monitoring Oversight, is responsible for providing proper oversight for all clinical monitoring activities as performed by the Contract Research Organization monitors for a given trial in accordance with the CRO Monitoring Oversight Plan, Monitoring Plan, Protocol, GCP and ICH Guidelines and other associated documents. The Manager of Monitoring Oversight will work cross-functionally with internal and external stakeholders to ensure ongoing inspection readiness, data quality, and data integrity.

Key Responsibilities Include:

  • Oversee clinical monitoring activities as performed by a Contract Research Organization (CRO) for assigned studies
  • Develop, execute, and manage the CRO Monitoring Oversight Plan, in collaboration with the study team, and ensure compliance
  • Generate, utilize and oversee metrics tools to assure the study monitoring activities are conducted according to the pertinent regulations, SOPs and study objectives (e.g., CTMS, DM Query Trends, Outstanding Monitoring Reports)
  • Review Monitoring Visit Reports for quality and trend identification purposes at both the site, study, and program level; communicate the trending and significant findings with the CRO and the study team
  • Oversee the CRO Monitoring Visit Reports finalization metrics to assure timelines are met
  • Proactively identify issues and risks, including study processes, monitoring or site issues (e.g. adherence to the study protocol, GCP compliance)
  • Manage/resolve site and/or monitoring issues including appropriate retraining, issue escalation, and/or implementation of corrective actions to prevent recurrence, as needed
  • Present clinical monitoring metrics to the Apellis study team at internal study team meetings and management, when applicable
  • Participate and contribute to the CRA team training including development of training materials and study tools for site and CRA use
  • Participate in Clinical Operations and cross functional initiatives such as process improvements and SOP development

Education, Registration & Certification: 

  • Bachelor's degree required. Scientific/health care field preferred, but not required

Experience:

  • 5+ years of relevant experience in clinical research
  • 2+ years of experience in Clinical Monitoring Role (field monitoring experience required)
  • Preferably experience as a Lead CRA from a CRO and/or biotech company
  • Experience managing clinical trial vendors preferred

 Skills, Knowledge & Abilities:

  • Strong knowledge of clinical research process and understanding of GCP/ICH guidelines
  • Extensive knowledge of trial oversight activities is required
  • Strong experience with clinical study technologies (IRT, eTMF, EDC)
  • Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands
  • Energetically embraces responsibilities, demonstrates ability to achieve goals
  • Has strong initiative, and functions well as part of a cross-functional team
  • Exhibits excellent time management and is able to work independently
  • Excellent verbal and written communication skills
  • Experience in a start-up environment preferred
  • Must be pro-active team player, flexible, and open to change

 Other:

  • Office based preferred
  • Remote potential
  • Minimal travel (up to 10%)

 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 http://apellis.com/careerbenefits.html to learn more.

Company Background:

We are a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, which is an integral component of the immune system, at the level of C3, the central protein in the complement cascade. We believe that this approach can result in broad inhibition of the principal pathways of the complement system and has the potential to effectively control a broad array of complement-dependent autoimmune and inflammatory diseases.

Visit http://apellis.com/about.html to learn more.

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 pneumocononiosis or any other characteristic protected under applicable federal, state or local law.

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.  

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 pneumocononiosis or any other characteristic protected under applicable federal, state or local law.