Clinical Document and Trial Master File (TMF) Manager

Noema is developing a late-stage portfolio of oral small molecule therapeutics with well-characterized mechanisms and distinct features that offer unique therapeutic advantages for neurological and other disorders. The Company is advancing three programs in parallel across orphan and large-market indications targeting therapeutic areas of high unmet need and limited competitioneach with blockbuster potential.

Tasks

In this role you will be responsible for the overall management quality and maintenance of essential clinical trial and other designated documents including the set up and maintenance of the electronic (eTMF) with a strong focus on ensuring that routine document management operations are performed with adherence with SOPs and ICH/GCP/TMF guidelines. This position plays a key role in electronic global TMF system management by filing organizing and maintaining digital records and coordinating the document management activities performed by third parties such as CROs vendors clinical sites collaborators as well as other internal and external team members to achieve inspection readiness in close collaboration with cross-functional teams for all of Noemas programs.

• Expanding and leading the company documentation handling and filing processes across program and study functional areas (e.g. Clinical Clinical Development and Sciences Data Management Biostatistics etc.) Handling filing and tracking of final documents in the company documentation management system
• Leading the completion of the study specific sponsor TMF Plan and review of the CRO TMF plan and index in association with the respective TMF Owner(s).
• Overseeing the set-up maintenance and archival of the study Trial Master File
• Performing quality control (QC) review of documents to be filed in the sponsor documentation system as well as in the CRO eTMF in accordance with standard operating procedures (SOPs) DIA TMF Reference Model and study specific TMF Plans
• Conducting periodic oversight QC of the CROs TMF to identify documentation gaps and quality issues and to initiate corrective actions
• Acting as the point of contact for audits/inspections related to the Trial Master File processes and activities and assisting with the development of corrective action plans related to Trial Master File findings
• Serving as TMF Subject Matter Expert to study teams and external partners
• Ensuring effective communication cross-functionally and issue escalation across TMF stakeholders
• Conducting all activities in compliance with Client and CRO SOPs and other regulatory guidance documents
• Assist with the maintenance of legal document tracking tools e.g. CDAs MSAs workorders etc. and filing of final legal documents in the companys document management system
• Performing other activities for the study team and/or program team as assigned
• Adhere to and maintain training records to demonstrate an appropriate level of competence in compliance with GCP applicable regulations and SOPs.

Requirements

• Bachelors Degree required preferably in a science/health related field
• 5 years working experience in the biotech and pharma industry (e.g. CRO experience)
• A minimum of 3 years experience with electronic Trial Master Files (eTMF) solutions (Veeva Vault Clinical PhlexTMF other eTMF platforms) is a must
• Solid experience with the DIA TMF Reference Model ALCOA standard and document management best practices is mandatory
• Experience with writing and/or updating SOPs job aids or work instructions that support eTMF management and processes
• Broad understanding of records management requirements in Drug Development
• Experience performing Quality Control of TMF documents and CRO oversight QCs
• Experience supporting audits and regulatory inspections preferred
• Familiarity with various aspects of clinical trials and regulatory requirements for clinical trials (ICH/GCP FDA EU-CTR).
• Pro-active attitude acting with sense-of-urgency and applying an entrepreneurial mindset
• Ability to think analytically identify problems as they are occurring (proactive management) and rapidly identify and implement solutions that are GCP compliant
• Excellent organizational and planning skills including strong attention to detail
• Strong interpersonal skills. Ability to collaborate effectively with the study team cross-functional team members and external partners (CROs vendors)
• Excellent communication skills. Proficiency in English (written and oral)

If you live in the Boston area and if your profile matches the above description we look forward to your application.