Contractor, Clinical Operations
PTC Therapeutics, Inc.
August 19, 2026
Remote friendly (New Jersey, United States)
United States
Operations
Job Description Summary
- Lead the execution of the complete life cycle of clinical trials for one or more indications, supporting study design through closeout and ensuring compliance with regulatory requirements and relevant company SOPs.
- Work cross-functionally with internal departments and external resources.
Responsibilities
- Plan, execute, and report clinical trials (timelines, protocol writing, CRF design, site selection, study drug forecasting, site/CRO management, data review, study reporting); recommend monitoring, safety, eligibility/enrollment, and data consistency strategies.
- Develop clinical strategies, trial designs, study plans, and deliverables; meet with investigators and internal scientific/clinical staff.
- Evaluate scientific literature; write/review/edit protocols, amendments, study manuals, informed consent forms, and related documents.
- Prepare and approve investigational site lists; negotiate site/vendor contracts and budgets; coordinate investigator meetings; respond to site/monitor questions.
- Manage timelines and budgets; provide progress reports.
- Support regulatory submissions and communications; write assigned report portions for agencies, IRBs, journals, and conferences.
- Review clinical trial data and assist in interpreting data for study reports and submissions.
- Compile/review report sections for agencies and IRBs/ethics committees; resolve site/monitor conduct questions.
Qualifications/Required Skills
- Bachelor’s degree in a scientific discipline + 7+ years US/global clinical research experience (pharma/biotech/CRO/university medical center or related).
- Knowledge of drug development and clinical trial design/conduct/data reporting; ability to recognize safety/efficacy trends.
- Hands-on GMP/GCP/ICH guideline experience; ability to influence without authority.
- Proficiency: Microsoft Word/Excel; strong verbal/written communication; independent and collaborative work in a matrix environment.
- Analytical, problem-solving, and strong planning/organization/time management.
Preferred
- Prior IND/NDA submission involvement; field monitor experience; medical writing experience/training; Microsoft Project and PowerPoint.
Travel: 0–10%
Compensation: Expected hourly range $60–80/hour (subject to assessment).
- Lead the execution of the complete life cycle of clinical trials for one or more indications, supporting study design through closeout and ensuring compliance with regulatory requirements and relevant company SOPs.
- Work cross-functionally with internal departments and external resources.
Responsibilities
- Plan, execute, and report clinical trials (timelines, protocol writing, CRF design, site selection, study drug forecasting, site/CRO management, data review, study reporting); recommend monitoring, safety, eligibility/enrollment, and data consistency strategies.
- Develop clinical strategies, trial designs, study plans, and deliverables; meet with investigators and internal scientific/clinical staff.
- Evaluate scientific literature; write/review/edit protocols, amendments, study manuals, informed consent forms, and related documents.
- Prepare and approve investigational site lists; negotiate site/vendor contracts and budgets; coordinate investigator meetings; respond to site/monitor questions.
- Manage timelines and budgets; provide progress reports.
- Support regulatory submissions and communications; write assigned report portions for agencies, IRBs, journals, and conferences.
- Review clinical trial data and assist in interpreting data for study reports and submissions.
- Compile/review report sections for agencies and IRBs/ethics committees; resolve site/monitor conduct questions.
Qualifications/Required Skills
- Bachelor’s degree in a scientific discipline + 7+ years US/global clinical research experience (pharma/biotech/CRO/university medical center or related).
- Knowledge of drug development and clinical trial design/conduct/data reporting; ability to recognize safety/efficacy trends.
- Hands-on GMP/GCP/ICH guideline experience; ability to influence without authority.
- Proficiency: Microsoft Word/Excel; strong verbal/written communication; independent and collaborative work in a matrix environment.
- Analytical, problem-solving, and strong planning/organization/time management.
Preferred
- Prior IND/NDA submission involvement; field monitor experience; medical writing experience/training; Microsoft Project and PowerPoint.
Travel: 0–10%
Compensation: Expected hourly range $60–80/hour (subject to assessment).