Contract, Clinical Operations

PTC Therapeutics - Remote, OR

Full-time

Remote, OR

Chemical Manufacturing

About the position

The Contract, Clinical Operations role is pivotal in providing the scientific and operational expertise necessary for leading the execution of clinical trials throughout their complete life cycle. This position requires adherence to regulatory requirements for various indications across therapeutic areas. The incumbent will work as an integral member of the clinical team, managing clinical trials from study design through to closeout. This role involves cross-functional collaboration with internal departments and external resources to address Clinical Operations-related issues, ensuring compliance with relevant regulatory requirements and company Standard Operating Procedures (SOPs). In this position, the individual will perform a variety of essential functions, including leading, directing, and contributing to the planning, execution, and reporting of clinical trials. Responsibilities include estimating clinical project timelines, writing protocols, designing Case Report Forms (CRFs), selecting study sites, forecasting study drug needs, managing sites and Clinical Research Organizations (CROs), reviewing data, and reporting study outcomes. The role also involves interacting with both external and internal project team members to develop clinical strategies, trial designs, and project deliverables. The incumbent will meet with investigators and PTC scientific and clinical staff to gather direction and feedback, and will assist in evaluating scientific literature and investigator advice to inform clinical strategy and protocol development. The role requires the preparation of investigational site lists, participation in the review and approval of investigational sites, and negotiation of contracts and budgets with sites and vendors. The incumbent will also plan, coordinate, and conduct investigator meetings, responding to inquiries from sites and trial monitors regarding trial conduct. Managing clinical study timelines and developing budgets for clinical trial programs are key responsibilities, along with presenting project progress reports at internal team meetings and investigator meetings. The individual will facilitate regulatory submissions and communications, writing assigned portions of reports for submission to regulatory agencies, institutional review boards, scientific journals, and conferences. Ongoing review of clinical trial data is essential to ensure timely, consistent, and accurate data, assisting in the interpretation of clinical data for clinical study reports and regulatory submissions. Overall, this position requires a proactive approach to managing clinical trials, ensuring compliance with regulatory standards, and contributing to the successful execution of clinical research initiatives.

Responsibilities

• Lead, direct, and contribute to the planning, execution, and reporting of clinical trials.
• Estimate clinical project timelines and write protocols.
• Design Case Report Forms (CRFs) and select study sites.
• Forecast study drug needs and manage sites and Clinical Research Organizations (CROs).
• Review data and report study outcomes.
• Interact with external and internal project team members to develop clinical strategies and trial designs.
• Meet with investigators and PTC scientific and clinical staff to gather direction and feedback.
• Evaluate scientific literature and investigator advice for clinical strategy and protocol development.
• Prepare investigational site lists and participate in the review and approval of investigational sites.
• Negotiate contracts and budgets with sites and vendors and present to the project team for approval.
• Plan, coordinate, and conduct investigator meetings, including presentations.
• Respond to inquiries from sites and trial monitors regarding trial conduct.
• Manage clinical study timelines and develop budgets for clinical trial programs.
• Present project progress reports at internal team meetings and investigator meetings.
• Facilitate regulatory submissions and communications during the submission process.
• Write assigned portions of reports for submission to regulatory agencies, IRBs, and scientific journals.
• Review clinical trial data to ensure timely, consistent, and accurate data.
• Assist in the interpretation of clinical data for clinical study reports and regulatory submissions.

Requirements

• Bachelor's degree in a scientific discipline.
• Minimum of 6 years of progressively responsible US and/or global experience in clinical research in a pharmaceutical, biotechnology, CRO, or related environment.
• Comprehensive working knowledge of the drug developmental process.
• Working knowledge of clinical trial design, conduct, data acquisition, and reporting.
• Ability to recognize safety and efficacy trends of clinical data.
• Hands-on experience supporting and understanding Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and International Conference on Harmonisation (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.
• Analytical thinker with excellent problem-solving skills.
• Excellent planning, organization, and time management skills.

Nice-to-haves

• Prior involvement in Investigational New Drug applications (INDs) and New Drug Applications (NDAs) submissions.
• Previous experience as a field monitor.
• Medical writing experience or training.
• Proficiency with Microsoft Project and PowerPoint.