Job Title: Senior Clinical Trial Manager

Job Description

We are seeking a dedicated and experienced Senior Clinical Trial Manager responsible for ensuring the proper conduct of clinical trials in accordance with the Monitoring Plan, applicable laws, Good Clinical Practices, and company standards. The role is crucial for achieving project goals, timelines, and quality benchmarks.

Responsibilities

• Ensure the proper conduct of clinical trials in accordance with the Monitoring Plan, applicable laws, Good Clinical Practices, and company standards.
• Accountable for study execution and drives key decisions.
• Author, provide input, and/or oversee program and/or study level documentation.
• Provide proper oversight of CROs and other third-party vendors to ensure quality of delivery, financial accuracy, and adherence to timelines.
• Manage financial aspects of clinical studies.
• Assist in the development and improvement of Clinical Operations processes and procedures.
• Mentor junior staff.
• Manage direct reports (if required).
• Involved in interviewing, hiring, and training employees.
• Participate in vendor selection, including critical review of contracts and work orders, and management of ongoing performance.
• Collaborate on SOP development.

Essential Skills

• Bachelor’s degree.
• 8-10 years of clinical operations experience.
• At least 5-6 years of Clinical Trial Management (CTM) experience.
• Experience with Phase II and III trials.
• Global clinical trial experience.
• Ability to run an entire study as the lead from start-up to closure and database lock activities.
• Strong communication skills, able to effectively communicate with doctors and Principal Investigators (PIs).
• Experience in rare disease trials.

Additional Skills & Qualifications

• Experience with Hereditary Angioedema (HAE) is a bonus.
• Experience managing all phases of an individual study.
• Commitment to a study for 2-3 years.
• Eager personality and demonstrated tenure at previous companies.

Work Environment

The team is small but highly supportive, valuing work-life balance and collaboration. The US and EU teams work together to balance workloads across time zones. The company has recently reported positive Top-line Phase 2 data and anticipates a busy year with 3-4 new studies launching. The role requires a professional who is committed and eager to contribute to the team's success.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $75 - $90