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Job Title: Associate Director Clinical Operations

Job Description

Align with the Head of Clinical Development Operations or Senior Director, Clinical Operations on plans for the successful implementation of studies. Responsible for the management of compounds at the program and franchise levels and may represent Clinical Operations on the Strategy and Portfolio or Clinical Sub Teams in their therapeutic area. Ensure operational aspects are incorporated into CDP planning and individual protocols to facilitate successful implementation of programs.

Responsibilities

+ Ensure high-quality delivery of all studies for which you are responsible, including individual studies as well as programs or franchises.

+ Lead the study team to develop a cross-functional, integrated study plan and create an initial study budget when sitting on a study team.

+ 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 the timing of major study milestones and the associated budget meet the needs of the overall development plan agreed to by the Global Project Team (GPT).

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

+ Oversee the CRO and provide timely input to ensure that the study is executed according to the agreed project plan.

+ Complete a study risk assessment and ensure mitigation and contingency measures are prepared and implemented.

+ Actively assess potential risks to the study and propose mitigation plans.

+ Responsible for oversight of all CROs utilized within their therapeutic area.

+ Work with Process Excellence and Risk Management to ensure oversight plans are in place for all studies falling under your responsibility.

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

+ Work with TMF Operations to ensure a state of inspection readiness for all TMFs and ensure quality expectations are met.

+ Manage CRO(s) performance to ensure adherence to the scope of work within timelines and budget at an overall study level.

+ Track major study milestones and monitor overall operational performance metrics through the life of the study.

+ Identify issues early and propose solutions. Whenever possible, resolve issues that have been escalated or if warranted, take issues to the appropriate governance committee.

+ Create the budget at study start-up and monitor the overall agreed budget against trial progress.

Essential Skills

+ 7+ years of clinical trial management experience.

+ Experience with global study management (Any Phase I-III).

+ Vendor/CRO management and oversight.

+ Strategic leadership ability with experience working in a matrix environment.

+ Experience in clinical research and hematology.

+ Experience with study start-up and monitoring.

+ Must have a current or previous title of Associate Director/Director.

Additional Skills & Qualifications

+ Oncology or Hematology experience.

+ Early development experience in oncology is a plus.

+ 6-8 years in CTM/Director roles.

+ 4-year degree.

Work Environment

This is a fully remote position. However, if located within 75 miles of Basking Ridge, NJ, it is not considered remote, and you may be required to work 1-2 days a week in-office at the manager’s discretion. No direct reports, but supported by matrix teams including 3 study managers and 1-2 study associates. For Phase 1b studies, the Associate Director leads the entire study.

Pay and Benefits

The pay range for this position is $85.00 - $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 Jun 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 [email protected] (%[email protected]) for other accommodation options.