eTMF Specialist(novotech)

Roles and Responsibilities

About The Role:

The Trial Master File (TMF) Specialist will serve as a subject matter expert and primary point of The 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 applicable Good Clinical Practice (GCP) guidelines, regulatory requirements and Standard Operating Procedures (SOPs). Oversee end to end TMF management and support cross 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 plus being 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.

• Subject Matter Expert for the TMF and lead internal document management 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.

• Assist with the development, implementation, and maintenance of the Trial Master Files (TMFs) to meet regulatory requirements.

• Support the TMF Management requirements to ensure TMF’s are always “inspection ready” by liaising with key stakeholders including QA.

• Ensure optimal use of eTMF functionality by analysing project and industry best practices and transferring manual processes into automated workflows, as possible.

• Generate and deliver TMF performance metrics and compliance reports to ensure adherence to company policies.

• Design and/or delivery training on TMF requirements and processes.

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

• Adhere to Company policies, procedures and guidelines and be quality minded in performance of duties.

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

• Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry.

• Ensure all communications with external parties and the performance of the study team presents a positive professional image of the company.