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Job Title: Senior Clinical Study ManagerJob Description

The Senior Clinical Study Manager is responsible for the delivery and execution of clinical studies across multiple geographic regions, adhering to Good Clinical Practices, Standard Operating Procedures, FDA regulations, and International Conference on Harmonization guidelines. This role involves routine interaction with both internal and external stakeholders, ensuring effective communication of project status and troubleshooting inquiries.

Responsibilities

+ Lead the development of the clinical study plan, including critical path activities and interdependencies for assigned clinical studies.

+ Create and manage the cross-functional Clinical Study Oversight Plan, ensuring adherence by the study team and coordinating activities with CROs and vendors.

+ Provide operational input into study protocol profiles, final protocols, and amendments.

+ Coordinate document review and medical writing tasks, including ICF, CRF guidelines, IB, and safety communications.

+ Oversee the CRO and vendor selection process, including the creation of scopes of work and trial feasibility activities.

+ Monitor clinical trial performance and quality metrics, ensuring issues are addressed and risks are mitigated.

+ Manage study budget, including monitoring against trial progress and approving vendor invoices.

+ Ensure compliance with quality measures and adherence to scope of work within timelines and budget at a task level.

+ Coordinate operational activities for study start-up, interim analysis, database lock, and study close-out activities.

+ Support department in codifying knowledge and best practices, preparing training, and making recommendations for improvement.

Essential Skills

+ Expert level written and verbal communication skills.

+ Strong decision-making abilities and clinical project management skills.

+ Minimum of 7 years experience in Pharma/biotech.

+ Experience in clinical trial study start-up and enrollment boosting activities.

+ Experience overseeing CROs and vendor management.

+ Proficiency in SharePoint, Excel, and PowerPoint.

+ Experience working with IRT systems and global recruitment requirements.

+ Recent experience in phase III oncology start-up, minimum 2 years.

Additional Skills & Qualifications

+ Bachelor's degree in Science or advanced degree.

+ Experience in clinical operations leading phase II or III global studies.

+ Prior experience working for a Japanese company is a plus.

+ Experience working as a CRA is a plus.

+ Solid Tumor experience preferred, lung experience is beneficial.

Work Environment

This is a 100% remote role for candidates in the Eastern timezone or local to the NJ/PA/NY area. The position requires flexibility for face-to-face meetings.

Pay and Benefits

The pay range for this position is $85.00 - $95.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• 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 is anticipated to close on Jun 13, 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.

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 due to a disability, please email [email protected] (%[email protected]) for other accommodation options.