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 completed.

The 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 of education and experience.

* Special knowledge or skills needed and/or licenses or certificates required.

Familiarity with clinical trial study documents.Knowledge of Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.Proficiency with Microsoft Word and Excel.Excellent verbal and written communication and skills.Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

*Special knowledge or skills and/or licenses or certificates preferred.

Experience with TMFs.  Performing periodic ad hoc, interim and end-of-study reviews/audits on paper and electronic TMFs for several trials to ensure TMF meets sponsor’s expectations (includes TMF reconciliation at study close-out)Experience interacting with CROs. Performing TMF QC for Contract Research Organization (CRO) TMF and ensuring quality of the TMF.Experience with Microsoft PowerPoint.

* Travel requirements

10%

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EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

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