eTMF Specialist

About The Role:

The Trial Master File (TMF) Specialist will serve as a subject matter expert and primary point ofThe Trial Master File (TMF) Specialist will serve as a subject matter expert and primary point of contact for activities associated with ensuring the TMFs meet all applicableGood Clinical Practice (GCP) guidelines, regulatory requirements and Standard Operating Procedures (SOPs). Oversee end to end TMF management and supportcross functional TMF users including driving innovative solutions related to trial master file management and TMF system usage. Collaborate with internal stakeholders to manage study specific TMF structure, system integrations and upgrading needs as required.

Minimum Qualifications & Experience:

• Graduate in clinical or life sciences with at least 3 years of TMF management experience including experience in study start-up, maintenance and close-out,and performing quality and completeness reviews.

• Subject Matter Expert knowledge of clinical trial documentation, DIA TMF Reference Model, clinical trial activities and related terminology. Detailed understanding of (e)TMF systems, principles, practices, and workflows plusbeing capable of working with a variety (e)TMF systems.

• Experience with coordinating document management activities performed by internal teams and developing SOPs for TMF Management.

Responsibilities:

• Lead the TMF strategy including development and maintenance of internal TMF SOPs and study processes ensuring a TMF plan is in place for all studies.

• SubjectMatterExpertfortheTMFandleadinternaldocumentmanagement activities in accordance with Novotech SOPs.

• Participate in the eTMF team including vendor management, contract oversight, monthly financial tracking and reporting and system administration.

• Work with functional groups to support, facilitate, train, and review filing of TMF documents and processes.

• Assistwiththedevelopment,implementation,andmaintenanceoftheTrialMaster Files (TMFs) to meet regulatory requirements.

• SupporttheTMFManagementrequirementstoensureTMF'sarealways inspection ready by liaising with key stakeholders including QA.

• Ensure optimal use of eTMF functionality by analysing project and industry best practicesandtransferringmanualprocessesintoautomatedworkflows,as possible.

• GenerateanddeliverTMFperformancemetricsandcompliancereportstoensure adherence to company policies.

• Designand/ordeliverytrainingonTMFrequirementsandprocesses.

• Actively involved and/or leads department and business improvement initiatives for the TMF.

• AdheretoCompanypolicies,proceduresandguidelinesandbequalitymindedin performance of duties.

• Participate in activities of the clinical operations group, including coordination of and presentation at clinical team meetings.

• UnderstandtheresponsibilitiesofNovotechasaserviceproviderinthe pharmaceutical industry.

• Ensureallcommunicationswithexternalpartiesandtheperformanceofthe study team presents a positive professional image of the company.

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.
We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.
We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.