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 competition—each 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 Noema’s 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 CRO’s 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 company’s 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

Bachelor’s 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.

Noema Pharma

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