Clinical Document and Trial Master File (TMF) Manager at Noema Pharma

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.TasksIn 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 systemLeading 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 FilePerforming 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 PlansConducting periodic oversight QC of the CROs TMF to identify documentation gaps and quality issues and to initiate corrective actionsActing 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 findingsServing as TMF Subject Matter Expert to study teams and external partnersEnsuring effective communication cross-functionally and issue escalation across TMF stakeholdersConducting all activities in compliance with Client and CRO SOPs and other regulatory guidance documentsAssist 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 systemPerforming other activities for the study team and/or program team as assignedAdhere to and maintain training records to demonstrate an appropriate level of competence in compliance with GCP applicable regulations and SOPs.RequirementsBachelors Degree required preferably in a science/health related field5 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 mustSolid experience with the DIA TMF Reference Model ALCOA standard and document management best practices is mandatoryExperience with writing and/or updating SOPs job aids or work instructions that support eTMF management and processesBroad understanding of records management requirements in Drug DevelopmentExperience performing Quality Control of TMF documents and CRO oversight QCsExperience supporting audits and regulatory inspections preferredFamiliarity 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 mindsetAbility to think analytically identify problems as they are occurring (proactive management) and rapidly identify and implement solutions that are GCP compliantExcellent organizational and planning skills including strong attention to detailStrong 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. Key Skills B2C,Facilities Management,Ado,Bus Driving,Application Support,Arabic Cuisine Employment Type : Employee Experience: years Vacancy: 1