Us PTC Therapeutics

Contract, Clinical Trial Associate

USA - New Jersey - Warren · Contract

Sponsorship not specified$35k-$47kDetected 22 days ago

GCPClinical TrialsClinical ResearchResearchCommunicationProblem SolvingTime ManagementMicrosoft OfficeGxP

About the role

PTC Therapeutics is a global commercial biopharmaceutical company.
For over 25 years our team has been deeply committed to a unified purpose: Extending life's moments for children and adults living with a rare disease.
We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.

Facilitates clinical document management activities.
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.
Performs quality checks of TMF-related documents, including clinical study site documents, email correspondence, training materials, and other related study documents.
Maintains current lists of correspondence.
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.
Prepares and manages clinical study conduct binders that include meeting agendas, minutes, status or patient trackers, patient screening logs and other documents as appropriate.
Performs other tasks and assignments as needed and specified by management.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

Assists with preparing, editing, producing, tracking and routing clinical documents as required.
Reviews vendor invoices for accuracy against budget and liaises with Finance as required to resolve issues, ensure payments are made, etc.
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
Experience with TMFs.

Minimum level of education and years of relevant work 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.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
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%

The hourly 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 well as review of internal equity.

Contributes to health authority inspection readiness by providing requested documents, from the TMF.
Bachelor's degree in a relevant life science or healthcare-related discipline and minimum 2 years of clinical research support experience in a pharmaceutical, biotechnology, or related environment.

Extending life's moments for children and adults living with a rare disease.
At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered.
Visit our website to learn more about our company and culture!

PTC Therapeutics is an equal opportunity employer.
We are committed to treating all applicants fairly and avoiding discrimination.
Click here to return to the careers page
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.

Liaises with Contract Research Organization (CRO) to ensure study-related documents are delivered to the sponsor in a timely and compliant manner

This listing is sourced directly from Us PTC Therapeutics's careers page and normalized into a canonical job model.