Senior Manager, Data Management

Clinical Waltham, Massachusetts


Description

Position Summary:

Are you always in search of more efficient ways to work? Are you tired of data organizations that don’t make data driven decisions? If you are passionate about doing your part to accelerate bringing life-changing therapies to patients, then we would love for you to join our team here at Apellis!

The Senior Manager, Data Management will be responsible for supporting the development and implementation of Apellis clinical data management strategies and processes to enable the delivery of data capture, review and reporting systems that facilitate timely availability of actionable data to enable fast and efficient drug development. The individual would also be responsible for the oversight of CDM activities outsourced to CROs, from study startup through study closeout.

Senior Manager, Data Management

Responsibilities

  • Contributes to developing strategies for and implementing ongoing improvements within Data Management to ensure the quality and integrity of the clinical data.
  • Develop, review and implement Clinical Data Management processes, policies and SOPs.
  • Develop Data Management outsourcing strategies, metrics and key performance indicators to aid the selection of CRO partners / Vendors and the ongoing management of partnerships.
  • Identifies opportunities, and implements solutions to globalize and standardize methods, processes, procedures, systems and templates in accordance with CDISC/SDTM requirements and industry best practices.
  • Participate in vendor qualifications and audits.
  • Oversees the planning, execution, and maintenance of major projects, if required.
  • Oversees the appropriate and effective use of data management information and system tools for data and report retrieval, data listing review, error detection and production of standard displays to ensure quality data.
  • Support study-level/program audit and inspection readiness activities as needed.
  • Lead data management support of submission activities.
  • Maintains proficiency in Data Management systems and processes through regular training and/or attendance at professional meetings/conferences. Takes the opportunity to network with colleagues for new and/or repeat business. May represent the Company at professional meetings or seminars.
  • Provide DM oversight of CRO and other external data vendors by developing and ensuring adherence to project timelines using metric reports and key performance indicators, if required.
  • Ensure the delivery of quality data by partnering with CROs and external vendors to develop and execute efficient quality data processes.
  • Train and mentor DM staff or members of the clinical trial team form other functions on processes, projects, systems and programs.
  • Perform hands-on data management responsibilities, if required.

Person Specification / Qualifications

Required

  • Bachelor’s degree, preferably in a scientific or engineering discipline such as Physical & Life Sciences, Statistics, Mathematics, Computer Science, IT, Biology.
  • 8+ years working in clinical data management, with experience building data management functions and developing initiatives designed to promote efficiency and productivity.
  • Extensive knowledge of clinical data management outsourcing models including functional-service providers and full-service CROs
  • Experience leading team of CRO data managers to ensure the timely provision of DM deliverables.
  • Advanced hands-on knowledge of data management processes and systems.
  • Knowledge of regulatory requirements (e.g. ICH, GCP, HIPAA)
  • Strong project management skills, and ability to effectively lead and collaborate with various business functions.
  • Demonstrated ability of working on multiple projects simultaneously, independently managing competing priorities, and define tracking tools to manage projects.
  • Excellent written and verbal communication skills, able to communicate effectively with senior management as well as with peers.
  • CDASH, CDISC & SDTM experience.
  • Demonstrated ability to influence without authority.
  • Demonstrate initiative, sound judgment and flexibility.
  • Solid understanding of clinical drug development processes.

Desirable / Preferred

  • Experience with data visualization, analytics and reporting tools
  • Experience programming in R, SAS, Python or other languages

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.

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.