Contractor, Clinical Operations

PTC Therapeutics, Inc.•Warren Township, NJ

4d•$60 - $80

About The Position

The Contractor, Clinical Operations provides the scientific and operational expertise required to lead the execution of the complete life cycle of clinical trials in accordance with applicable regulatory requirements for one or more indications within or across therapeutic areas. As an integrated member of the clinical team, the incumbent manages clinical trials from study design through closeout and works cross-functionally with internal departments and external resources on Clinical Operations matters. The role supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs). The position contributes to clinical trial planning, execution, and reporting, including protocol development, site and CRO management, timelines, budgets, data review, and study reporting. It also supports regulatory submissions and communications, investigator and site interactions, and the preparation and review of clinical and regulatory documents. The role requires a bachelor’s degree in a scientific discipline and at least seven years of progressively responsible clinical research experience. Travel is listed as 0–10%. The expected hourly range is $60–$80, contingent on candidate qualifications and internal equity.

Requirements

Bachelor’s degree in a scientific discipline.
At least 7 years of progressively responsible US and/or global clinical research experience in a pharmaceutical, biotechnology, CRO, university medical center, or related environment.
Comprehensive working knowledge of the drug development process.
Working knowledge of clinical trial design, conduct, data acquisition, and reporting.
Ability to recognize safety and efficacy trends in clinical data.
Hands-on experience supporting and understanding GMP, GCP, and ICH guidelines.
Ability to influence without direct authority.
Proficiency with Microsoft Word and Excel.
Excellent verbal and written communication skills.
Ability to work independently and collaboratively in a fast-paced, matrixed team environment with internal and external team members.
Analytical thinking, excellent problem-solving skills, and ability to adapt to changing priorities and deadlines.
Excellent planning, organization, and time-management skills, including the ability to support and prioritize multiple projects.

Nice To Haves

Prior involvement in Investigational New Drug (IND) and New Drug Application (NDA) submissions.
Previous experience as a field monitor.
Medical writing experience or training.
Proficiency with Microsoft Project and PowerPoint.

Responsibilities

Lead, direct, and contribute to clinical trial planning, execution, and reporting, including estimating timelines, writing protocols, designing Case Report Forms, selecting sites, forecasting study drug, managing sites and CROs, reviewing data, and reporting study results.
Recommend strategies for monitoring, safety, eligibility, enrollment, and data consistency.
Work with internal and external project team members on clinical strategies, trial design, study plans, and deliverables; meet with investigators and PTC scientific and clinical staff to obtain direction and feedback.
Evaluate scientific literature and investigator advice to inform clinical strategy and protocol development; write, review, or edit protocols, amendments, study manuals, informed consent forms, and related documents.
Prepare investigational site lists and participate in site review and approval.
Negotiate site and vendor contracts and budgets and present them to the project team for approval.
Plan, coordinate, and conduct investigator meetings, including giving presentations; respond to site and trial monitor questions about trial conduct.
Manage clinical study timelines using appropriate project management tools; develop budgets and manage clinical trial program expenditures for sites and vendors.
Present accurate, succinct clinical study progress reports at internal team and investigator meetings.
Facilitate regulatory submissions and communications with appropriate team members; write assigned portions of reports for regulatory agencies, IRBs, scientific journals, and conferences.
Review clinical trial data on an ongoing basis to support timely, consistent, and accurate data; assist with interpretation of clinical data for study reports and regulatory submissions.
Compile and review assigned portions of reports for regulatory agencies, IRBs, and Ethics Committees.
Perform other tasks and assignments as needed and specified by management.