Job Description Summary:

The Contract TMF Specialist collects, reviews, files, maintains and archives essential regulatory documents for the Trial Master File (TMF) in accordance with Good Clinical Practice (GCP), E6 International Conference on Harmonisation (ICH) Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, European Medicines Agency (EMA) Clinical Trials Directives), and company Standard Operating Procedures (SOPs) as appropriate. Essential regulatory documents include, but may not be limited to: externally-sourced documents from clinical investigators, Institutional Review Boards (IRBs)/ethics committees, competent authorities, etc., and internally-sourced documents (e.g., clinical protocol, Data Management Plan [DMP], Statistical Analysis Plan [SAP], etc.) for domestic and international clinical studies.

The incumbent works cross-functionally with internal departments and external resources on Clinical Documentation related issues.

The Contract TMF Specialist supports adherence to relevant regulatory requirements and company SOPs as appropriate.Job Description:

ESSENTIAL FUNCTIONS

Works with multi-functional teams (internal and external) to ensure the maintenance of TMFs, both electronic and paper, in a state of inspection readiness.Tracks effective and expiration dates of external documents (e.g., clinical laboratory certifications, Medical Licenses, and curriculum vitae [CVs]).Collects, reviews, and indexes essential documents in accordance with TMF structure.Uploads TMF documents into the eDMS and/or other document files, e.g., as “working documents” while the study is ongoing.Acts as TMF Subject Matter Expert (SME) and point-of-contact for study teams and TMF stakeholders.Provides oversight of Contract Research Organization (CRO)/ Vendors when TMF is outsourced.Provides support and TMF guidance during audit and/or inspections.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.

High school diploma and a minimum of 3 years of relevant professional experience with essential regulatory documents in a pharmaceutical, biotechnology, CRO or related environment.

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

Thorough knowledge of essential regulatory documents required for the conduct of clinical studies, as described in the ICH E6 Guidelines and in relevant regulations (e.g., Food and Drug Administration (FDA) 21 CFR).Knowledge and working experience with TMF Reference Model.Proficiency with Microsoft Office.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.

Associate’s and/or Bachelor’s degree.Experience using eDMS software.Demonstrated experience identifying, developing, and implementing improvements to departmental processes that increase efficiency and that maintain or improve quality (e.g., increasing the numbers of documents processed).Demonstrated ability to identify opportunities to improve study sites’ processing of essential regulatory documents. This includes communicating recommended changes to the sponsor’s study management and site monitoring staff.

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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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