Senior TMF Manager & Documentation Lead

Corbus Pharmaceuticals Inc•Norwood, MA

23d•Hybrid

About The Position

This position is suitable for someone who is committed to a career in document management, compliance and inspection readiness. It transcends multiple disciplines and bridges quality with operations. As such, the person we are looking for is someone with the capacity to lead this important activity. This position will ideally be based hybrid in the Norwood office but open to East Coast candidates willing to travel monthly to Norwood.

Requirements

Education to Bachelor of Science level, preferably in a scientific discipline or equivalent level of experience of document management or equivalent years of relevant experience.
A minimum of 5 years’ experience with Clinical Document Management, TMF, and/or Clinical Quality Control
A current knowledge and experience of Veeva eTMF, RIM and other products is a requirement
Detailed knowledge of regulatory requirements (including ICH, EMA, and FDA guidelines)
Strong knowledge of key clinical trial documents (e.g., IBs, ICFs, CRFs, Protocols, regulatory approval documents) as well other documentation types pertaining to Manufacturing and Regulatory e.g. (IND modules, CTA applications, IMPDs etc)
An understanding of the clinical development process
Knowledge/understanding of technologies to support document collection and archiving
Must have a friendly disposition and strong verbal, written and interpersonal communication skills, especially needed to work in and effectively manage a cross-functional team.
Should be confident to speak as an SME, engage with Senior Management and act as a train-the-trainer where necessary
Should be able to work globally across multiple time-zones, cultures and geographies from our office HQ or remotely
Ability to drive multiple cross-functional initiatives with conflicting priorities
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

Responsibilities

Oversee document management activities at our Contract Research Organization (CRO) and Contract Drug Manufacturing Organization (CDMO) partners ensuring that electronic document management systems (EDMS) are always inspection-ready.
Provide regular and accurate reports of EDMS completeness, quality and timeliness to Senior Management.
Be a subject matter expert (SME) for Good Documentation Practice (GDP), promoting good practice throughout the company and with vendors.
Providing training on company EDMS systems to Corbus employees, consultants and vendors (as necessary).
In conjunction with Quality Assurance, developing and maintaining standard operating procedures (SOPs), working instructions (WIs), guidance, training materials and tools to ensure compliance and effective utilization of EDMS and appropriate filing of documentation across the Corbus organization (and vendors).
Acting as designated Archivist.
As necessary, supporting all Corbus functions with documentation filing, QC and retrieval.
Ensuring that documentation is retained according to relevant regulations.
Collaborating with IT to ensure that validation documentation is in place and available for inspection for EDMS systems.
Day-to-day management of Veeva Vaults including document filing, document QC, organization and attendance of oversight meetings, review of invoices and license management.
Collaboration with IT to ensure access has been provided appropriately to EDMS products.
Reporting to Snr Director, Clinical/Development Operations (Non-oncology), you will work closely with all R & D functions and IT.