Contractor, Clinical Operations

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. At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging. Visit our website to learn more about our company and culture: www.ptcbio.com.

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 appropriate regulatory requirements for one or more indications within or across therapeutic areas. The incumbent works as an integrated member of the clinical team to manage clinical trial(s) from study design through close out. The incumbent works cross-functionally with internal departments and external resources on Clinical Operations related issues. The Contractor, Clinical Operations ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Responsibilities

• Perform as an integrated member of the clinical team to lead, direct and contribute to the planning, execution, and reporting of clinical trials, including estimation of clinical project timelines, protocol writing, Case Report Form (CRF) design, site selection, study drug forecasting, site and Clinical Research Organization (CRO) management, data review, and study reporting; recommend 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; meet 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; write, review and/or edit study protocols, protocol amendments, study manuals, informed consent forms, and related documents.
• 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 at the meetings; respond to questions from sites and trial monitors regarding trial conduct.
• Manage clinical study timelines using appropriate project management tools; develop budgets and manage expenditures for clinical trial program, including those for investigational sites and vendors; present project progress reports through accurate, succinct summaries of clinical study work at internal team meetings and investigator meetings.
• Facilitate regulatory submissions and communications by working with appropriate team members during the submission process; write assigned portions of reports for submission to regulatory agencies, institutional review boards, scientific journals, and conferences.
• Provide ongoing review of clinical trial