Job Title: Study Start Up Manager

Job Description

We are seeking an experienced Study Start Up Manager who will be responsible for managing start-up activities, including essential document collection and review, informed consent reviews, clinical site budget reviews, and clinical trial agreement language. The ideal candidate will have a strong background in clinical documentation and research, with specific experience in study start-up from a sponsor's perspective.

Responsibilities

• Manage and oversee start-up activities for clinical trials.
• Collect and review essential documents required for study initiation.
• Conduct informed consent reviews to ensure compliance with regulatory standards.
• Review and negotiate clinical site budgets.
• Evaluate and negotiate clinical trial agreement language.
• Collaborate with global teams to ensure successful study start-up.
• Leverage pulmonary experience to contribute to study design and execution.

Essential Skills

• Proven track record in study start-up from a pharma/sponsor's perspective.
• Experience in clinical documentation and research.
• Proficiency in managing essential document collection and review.
• Ability to conduct informed consent reviews.
• Experience in clinical site budget reviews.
• Expertise in negotiating clinical trial agreements.
• Global experience in clinical trials.
• Pulmonary experience.

Additional Skills & Qualifications

• Recent biotech/pharma study start-up experience.

Work Environment

This role is 100% remote, with a preference for candidates in the Eastern Standard Time (EST) zone.

Pay and Benefits

The pay range for this position is $55.00 - $68.00

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position will be accepting applications until Jan 20, 2025.

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 : $55 - $68