Associate Director Clinical Operations

Actalent • Raleigh, NC • 2h ago

Job Title: Associate Director, Clinical OperationsJob Description

The Associate Director, Clinical Operations will align with the Head of Clinical Development Operations or Senior Director, Clinical Operations to successfully implement studies and manage compounds at the program and franchise levels. This role may represent Clinical Operations on Strategy and Portfolio or Clinical Sub Teams within their therapeutic area, ensuring operational aspects are incorporated into CDP planning and individual protocols to facilitate successful implementation of programs.

Responsibilities

Ensure high-quality delivery of all studies, including individual studies and programs or franchises.

Lead study teams to develop cross-functional, integrated study plans and create initial study budgets.

Review study feasibility assessments provided by the CRO(s), lead the CRO selection process, and provide input into ARO selection.

Validate the study implementation plan provided by the CRO through to study close out and CSR writing.

Ensure major study milestones and associated budgets meet the needs of the overall development plan.

Lead site selection, site qualification discussions, kick-off meetings, and study team meetings.

Oversee CROs and provide timely input to ensure study execution aligns with the agreed project plan.

Complete study risk assessments and ensure mitigation and contingency measures are prepared and implemented.

Design, update, and implement innovative and best-in-class procedures and SOPs related to clinical study oversight.

Ensure a state of inspection readiness for all TMFs and meet quality expectations.

Manage CRO performance to ensure adherence to scope of work within timelines and budget.

Track major study milestones and monitor operational performance metrics throughout the study lifecycle.

Create and monitor study budgets, working closely with internal and external stakeholders.

Essential Skills

Clinical operations expertise

Vendor management experience

Oncology and hematology knowledge

7+ years of clinical trial management experience

Global study management experience (Phase I-III)

Strategic leadership in a matrix environment

Experience in clinical research and study start-up

Additional Skills & Qualifications

Previous title of Associate Director / Director

Early development experience in oncology is a plus

6-8 years in CTM/Director roles

Candidates from Functional Service Providers (FSP) with Pharma embedding are welcome

4-year degree

Experience with study start-up/enrollment

Work Environment

The position is fully remote, with the exception of candidates located within 75 miles of Basking Ridge, NJ, who may be required to work in-office 1-2 days a week at the manager's discretion. The role involves collaboration with matrix teams, including 3 study managers and 1-2 study associates, leading entire phase 1b studies.

Pay and Benefits

The pay range for this position is $89.00 - $99.00/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 Aug 23, 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 actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

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