Contract, Clinical Trial Associate

reputed company Therapeutics is a global reputed company biopharmaceutical company. For over 25 years reputed company has been deeply committed to a reputed company purpose: Extending life’s moments for children and adults living with a rare disease. At reputed company, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from reputed company backgrounds to join reputed company, fostering a strong reputed company of belonging. Visit our website to learn more about reputed company and culture! Site: www.ptcbio.com Job reputed company reputed company: The Contract, Clinical Trial Associate provides clinical study and Trial Master File (TMF) support for clinical operations. This involves supporting Clinical Trial Managers (CTMs) with activities reputed company to: study start-up; investigator site feasibility and selection; essential document review reputed company to investigator site initiation and investigational product release and patient enrollment. This position may also reputed company support in project team meetings by capturing meeting minutes/reputed company items and following up with reputed company 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 reputed company issues. The Contract, Clinical Trial Associate supports adherence to relevant regulatory requirements and company reputed company Operating Procedures (SOPs) as appropriate. . Job reputed company: ESSENTIAL FUNCTIONS Primary duties/responsibilities: Facilitates clinical document management activities. This includes, but may not be limited to: Ensures the reputed company 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 reputed company reviews/audits of TMF. This includes the reconciliation of the TMF at study reputed company-out. Responds to TMF-reputed company inquiries and resolves issues reputed company stipulated timelines. Performs reputed company checks of TMF-reputed company documents, including clinical study site documents, email correspondence, training materials, and other reputed company study documents. Applies ICH guidelines to generate filing indices. Maintains reputed company 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-reputed company documents are delivered to the sponsor in a reputed company and compliant manner. Supports CTMs with activities reputed company to: study start-up; investigator site feasibility and selection; essential document review reputed company to investigator site initiation and investigational product release and patient enrollment. Assists CTMs with the reputed company of CRO(s) and other study-reputed company, reputed company-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 review of monitoring visit reports. 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 reputed company-reputed company discipline and minimum 2 years of clinical research support experience in a pharmaceutical, biotechnology, or reputed company environment.
• Special knowledge or skills needed and/or licenses or certificates required. Familiarity with clinical trial study documents. Knowledge of Good Clinical reputed company (GCP) and International Conference on Harmonisation (ICH) guidelines. Proficiency with reputed company Word and reputed company. Excellent verbal and written communication and skills. Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of reputed company 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 reputed company. *Special knowledge or skills and/or licenses or certificates preferred. Experience with TMFs. Performing periodic reputed company, interim and end-of-study reviews/audits on reputed company and electronic TMFs for several trials to ensure TMF meets sponsor’s expectations (includes TMF reconciliation at study reputed company-out) Experience interacting with CROs. Performing TMF QC for Contract Research Organization (CRO) TMF and ensuring reputed company of the TMF. Experience with reputed company PowerPoint.
• Travel requirements 10% Expected reputed company reputed company: $35 - $47/hour. The reputed company salary offered will be contingent on assessment of the candidate's education level, background, and experience relative to the requirements of the position they are being considered for, as reputed company as review of internal equity. EEO Statement: reputed company Therapeutics is an equal opportunity employer. We welcome applications from reputed company individuals, regardless of race, reputed company, national reputed company, gender, age, physical characteristics, reputed company reputed company, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender reputed company, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating reputed company applicants fairly and avoiding discrimination. Click here to return to the careers page reputed company reputed company Therapeutics is a global biopharmaceutical company dedicated to the discovery, development and commercialization of clinically differentiated medicines for children and adults living with rare disorders. reputed company is advancing a robust and reputed company pipeline of transformative medicines as part of its mission to reputed company reputed company to best-in-class treatments for patients with unmet medical needs. Our reputed company is to reputed company our scientific expertise and global reputed company infrastructure to optimize value for patients and other stakeholders. To learn more about reputed company, please visit www.ptcbio.com and follow us on reputed company, X, Instagram and reputed company. Please Beware of False Job Advertisements reputed company Therapeutics is aware of employment hiring scams that reputed company false use of reputed company, leader and employee names to defraud job seekers. reputed company does not reputed company job offers without interviews and we never ask candidates for reputed company. If you have encountered a job posting or been approached with a job offer from an email address that does not use ptcbio.com, or that you feel may be fraudulent, we strongly encourage you NOT to respond.

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