Job Description Summary: The Senior Specialist, Clinical Trial Associate provides clinical study and Trial Master File (TMF) support for clinical operations. This involves supporting Clinical Trial Managers (CTMs) with activities related to: study start-up; investigator site feasibility and selection; essential document review related to investigator site initiation and investigational product release and patient enrollment. This position may also provide support in project team meetings by capturing meeting minutes/action items and following up with action item owners to ensure tasks are incumbent is also responsible for contributing to study budget management. This includes the review of vendor invoices for accuracy against budget, tracking vendor payments. The incumbent works cross-functionally with internal departments and external resources on Clinical Development related issues. The Senior Specialist, Clinical Trial Associate supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
.Job Description:

ESSENTIAL FUNCTIONS

Primary duties/responsibilities:

Facilitates clinical document management activities. This includes, but may not be limited to:
- Ensures the proper application of regulatory requirements pertaining to the management of clinical documents.
- Ensures electronic trial master files (eTMF) are compliant with relevant regulatory requirements by performing periodic and ad hoc reviews/audits of TMF. This includes the reconciliation of the TMF at study close-out.
- Responds to TMF-related inquiries and resolves issues within stipulated timelines.
- Performs quality checks of TMF-related documents, including clinical study site documents, email correspondence, training materials, and other related study documents.
- Applies ICH guidelines to generate filing indices.
- Maintains current lists of correspondence.
- Contributes to health authority inspection readiness by providing requested documents, from the TMF.
- Liaises with Contract Research Organization (CRO) to ensure study-related documents are delivered to the sponsor in a timely and compliant manner.

Supports CTMs with activities related to: study start-up; investigator site feasibility and selection; essential document review related to investigator site initiation and investigational product release and patient enrollment.

Assists CTMs with the oversight of CRO(s) and other study-related, third-party vendors to ensure study requirements are met.

Assists with preparing, editing, producing, tracking and routing clinical documents as required. This includes, but may not limited to, clinical protocols. Investigator Brochures and informed consents.

Assists with the development and production of presentations, reports, submissions, articles, and other materials.

Prepares and manages clinical study conduct binders that include meeting agendas, minutes, status or patient trackers, patient screening logs and other documents as appropriate.

Reviews vendor invoices for accuracy against budget and liaises with Finance as required to resolve issues, ensure payments are made, etc. Applies understanding of clinical contract terms.

Performs other tasks and assignments as needed and specified by management.

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

* Minimum level of education and years of relevant work experience.

Bachelor's degree in a relevant life science or healthcare-related discipline and minimum 4 years of clinical research support experience in a pharmaceutical, biotechnology, or related environment or a recognized equivalent

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Senior Specialist, Clinical Trial Associate at PTC Therapeutics