Clinical Trials Operations Contractor

PTC Therapeutics, Inc.; New Jersey; On-site; USD 83,000 - 110,000; Full time

Job summary

PTC Therapeutics, Inc. is seeking a Contractor, Clinical Operations to lead the execution of the full lifecycle of clinical trials across indications or therapeutic areas.

You will work as part of the clinical team to plan, design, execute, and report studies and ensure regulatory compliance. The role requires a scientific degree and at least 7 years of clinical research experience in pharma/CRO settings, with strong project management and regulatory submission capabilities.

Qualifications

• Bachelor’s degree in a scientific discipline and a minimum of 7 years progressively responsible US and/or global experience in clinical research in a pharmaceutical, biotechnology, CRO, university medical center or related environment.
• Special knowledge or skills needed and/or licenses or certificates required.
• Comprehensive working knowledge of the drug developmental process.
• Working knowledge of clinical trial design, conduct, data acquisition, and reporting.

Responsibilities

• Lead and contribute to the planning, execution, and reporting of clinical trials, including estimation of clinical project timelines, protocol writing, CRF design, site selection, study drug forecasting, site and CRO management, data review, and study reporting; recommends monitoring, safety, eligibility, enrollment, and data consistency strategies.
• Interact with external and internal project team members to assist in the development of clinical strategies, trial design, study plans, and project deliverables; meets with investigators and PTC scientific and clinical staff to obtain direction and feedback.
• Assist in the evaluation of scientific literature and investigator advice regarding current clinical practice as a component of clinical strategy and protocol development; writes, reviews and/or edits study protocols, protocol amendments, study manuals, informed consent forms, and related documents.
• Prepares investigational site lists and participates in the review and approval of investigational sites; negotiates contracts and budgets with sites and vendors and presents to the project team for approval; plans, coordinates, and conducts investigator meetings including presentations at the meetings; responds to questions from sites and trial monitors regarding trial conduct.
• Manages clinical study timelines using the appropriate project management tools; develops budgets and manages expenditures for clinical trial program, including those for investigational sites and vendors; presents project progress reports through accurate, succinct summaries of clinical study work at internal team meetings and investigator meetings.
• Facilitates regulatory submissions and communications by working with appropriate team members during the submission process; writes assigned portions of reports for submission to regulatory agencies, institutional review boards, scientific journals, and conferences.
• Provides on-going review of clinical trial data to ensure timely, consistent, and accurate data; assists in the interpretation of clinical data in preparation for clinical study reports and regulatory submissions.
• Compiles and reviews assigned portions of reports for submission to regulatory agencies and Institutional Review Boards (IRBs) and Ethics Committees (ECs).
• Addresses and resolves questions from sites and trial monitors regarding trial conduct.
• Performs other tasks and assignments as needed and specified by management.

Skills

Clinical research

Regulatory submissions

Project management

GMP/GCP/ICH

Education

Bachelor’s degree in a scientific discipline

Tools

MS Word

MS Excel

MS Project

PowerPoint

Job description

PTC Therapeutics, Inc. is seeking a Contractor, Clinical Operations to lead the execution of the full lifecycle of clinical trials across indications or therapeutic areas.

You will work as part of the clinical team to plan, design, execute, and report studies and ensure regulatory compliance. The role requires a scientific degree and at least 7 years of clinical research experience in pharma/CRO settings, with strong project management and regulatory submission capabilities.