Contract Clinical Operations Lead

PTC Therapeutics, Inc; New Jersey; On-site; USD 171,924,000 - 229,233,000; Full time

Job summary

PTC Therapeutics, Inc is seeking a Contractor, Clinical Operations to lead and coordinate the life cycle of clinical trials across indications, ensuring compliance with GMP/GCP/ICH and regulatory requirements. The role entails planning, site management, data review, and reporting within a fast-paced team.

Responsibilities include protocol development, site and CRO oversight, budgeting, and timely submissions.

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.
• 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 GMP, GCP, and ICH guidelines.
• Ability to influence without direct authority.
• Proficiency with Microsoft Word and Excel.
• Excellent verbal and written communication and skills.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

Responsibilities

• Lead, direct and contribute to planning, execution, and reporting of clinical trials, including timelines, protocol writing, CRF design, site selection, forecasting, CRO management, data review, and study reporting.
• Interact with internal and external team members to develop clinical strategies, trial design, and project deliverables.
• Assist in evaluating scientific literature and investigator input for protocol development and study documents.
• Prepare investigational site lists, negotiate contracts and budgets, and coordinate investigator meetings.
• Manage study timelines and budgets, and present progress at team/investigator meetings.
• Facilitate regulatory submissions and communications with team members during submissions.
• Review clinical trial data for timely, accurate interpretation and reporting.
• Compile and review reports for submissions to regulatory agencies and IRBs/ECs.
• Address questions from sites and monitors regarding trial conduct.

Skills

GMP/GCP/ICH knowledge

Drug development process

Communication skills

Microsoft Word/Excel

Project management

Education

Bachelor's degree in scientific discipline

Tools

Microsoft Project

PowerPoint

Job description

PTC Therapeutics, Inc is seeking a Contractor, Clinical Operations to lead and coordinate the life cycle of clinical trials across indications, ensuring compliance with GMP/GCP/ICH and regulatory requirements. The role entails planning, site management, data review, and reporting within a fast-paced team.

Responsibilities include protocol development, site and CRO oversight, budgeting, and timely submissions.