Document Management Lead

  • Full-time

Company Description

Corbus Culture:

Our passion. Our purpose. At Corbus, it starts at our core.

We look for unique talent. Our people are brilliant, they break barriers and are not defined by a title. Eclectic experiences make Corbus a special place to share ideas and grow. At Corbus, transformative ideas can come from anyone, anywhere and anytime. We offer our team flexibility and the opportunity to excel in their professional journey. We provide a welcoming space where collaboration, mentorship and diversity are encouraged. We come together, like no other, to elevate each other and focus on what’s best for patients.

About Corbus

Corbus is committed to leveraging our expertise in immunology to fulfill our purpose of developing innovative new medicines that improve the lives of people living with inflammatory, fibrotic, and metabolic diseases, and cancer. Corbus’ current pipeline includes small molecules that activate or inhibit the endocannabinoid system and anti-integrin monoclonal antibodies that block activation of TGFβ. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on Twitter, LinkedIn and Facebook.

Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer

 

Job Description

The Document Management Lead (DML) is responsible for championing Good Documentation Practice (GDP) within Corbus. Key to this will be overseeing and assisting with documentation management activities at Corbus, ensuring documents are identified, stored, and archived according to Corbus policies and procedures. As DML, you will be required to work collaboratively with group members and contribute to positive team relationships both with Corbus and our vendors. This role serves as a subject matter expert in document management operations, systems and processes.

MAIN DUTIES / RESPONSIBILITIES (include, but not limited to the following):

  • Collaborates with R & D functional teams to ensure documentation is created, named and file according to Corbus standards and GDP.
  • Maintains source documentation and data securely in Corbus electronic repositories to support data integrity
  • Acts as a subject matter expert for Trial Master Files including the following activities:
    • Population of metadata and QC of uploaded TMF documentation
    • Periodic reviews of the TMF, including reporting to study teams on completeness, timeliness and Quality
    • Query resolution on documentation with stakeholders
    • Assisting with the oversight of the eTMF vendor and related TMF setup and maintenance processes, eTMF user support and training;
    • Liaising with other functional areas and CRO stakeholders to ensure consistent processes and procedures for the management of the TMF
    • Maintenance of inspection-readiness with respect to documentation
    • Liaise with other functional areas and CRO stakeholders to ensure consistent processes and procedures for the management of the TMF.
  • Facilitate the writing or update of departmental SOPs, WIs, job-aids and guidelines as needed.
  • Acts as the designated Archivist for Corbus, being responsible for archive selection, maintenance according to Corbus policies and oversees the final destruction of document, as required.

WORKING RELATIONSHIPS:

Working closely with other Functional Groups with R & D (especially Clinical Operations and R & D Business Operations), Corbus IT, the eTMF vendor, and other vendors providing R & D services to Corbus

 

 

Qualifications

 

EDUCATION AND EXPERIENCE REQUIRED:

  • Education to Bachelor of Science level or equivalent, preferably in a scientific discipline or equivalent in experience of Document Management
  • Experience with Clinical Document Management, TMF, and/or Clinical Quality Control is a requirement, knowledge of Veeva eTMF is both desirable and an advantage
  • Detailed knowledge of domestic and international regulatory requirements (including ICH, EMA, and FDA guidelines)
  • Strong knowledge of key clinical trial documents (e.g., IBs, ICFs, CRFs, Protocols, regulatory approval documents)
  • Solid understanding of the clinical development process
  • Knowledge/understanding of technologies to support document collection and archiving

 

SKILLS AND APTITUDE REQUIRED:

  • Must have strong verbal, written and interpersonal communication skills, especially needed to work in and effectively manage a cross-functional team
  • Ability to drive cross-functional projects with conflicting priorities
  • Ability to work with individuals from a wide range of cultures
  • Must be very detail oriented and possess excellent organizational and time management skills
  • Ability to work both independently and as part of a team, both within direct and matrix environments
  • Proficient computer skills, especially using MS Office

Additional Information

All your information will be kept confidential according to EEO guidelines.